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Pickleball injuries are on the rise: 5 preventive tips to keep you on the court – The Manual

Posted: September 16, 2022 at 2:13 am

Pickleball is Americas favorite emerging recreational sport at the moment. The game that was first developed on Washingtons Bainbridge Island in 1965 is taking the country by storm for its ease of access, fun, quick action, and social attraction.

Whats lost in the hype, however, is that the sport is leading to numerous injuries. An analysis of pickleball-related injuries using data from the National Electronic Injury Surveillance System of the U.S. Consumer Product Safety Commission found the annual estimated number of injuries rising precipitously from 2013 to 2017.

Even though the court is much smaller, and requires much less ground to cover, numbers show that pickleball-related emergency room visits are quickly catching up tennis-related traumas, especially for seniors. Using data from 2001 to 2019 (as reported by the NEISS), analysts found a weighted total of 28,984 pickleball injuries as compared with 58,836 tennis injuries.

Although pickleball-related injuries have many similarities with those associated with other racquet sports, there were various differences (e.g., increasing trend and older patient age) that may need to be considered for the prevention and management of injuries related to the sport, concluded the article.

This was especially true for seniors as 85% of medical stresses occurred in people over 60. Still, all players risk any number of athletic impairments including ankle sprains, muscle strains, tendon pulls/tears, shoulder problems, rotator cuff injuries, and lower back problems such as disc injuries and strains.

No need to stress, though. The Manual is here with a guide on how to prevent devastating pickleball injuries.

Any sport that you play, youre going to want to support that condition with cross-training. The United States Office of Disease Prevention and Health Promotion recommends 150 minutes of moderate-intensity aerobic physical activity per week. High-impact cardiovascular exercise includes running, jogging, and sports like basketball, or skiing. While these will work wonders for physical shape, they can be hard on limbs and joints. Lower impact activities such as biking, elliptical machines, pool walking, or swimming can promote fitness with less destructive contact with the ground and other bodies.

Sleep is key to mental and physical recovery.

The ODPHPs Physical Activity Guidelines note that moderate to vigorous activity improves the quality of sleep in adults.

You break your body down with activity, which leads to improved physical conditioning and a mental calm that encourages healthy, healing sleep. Its a beautiful system.

For optimal health, the American Academy of Sleep Medicine and Sleep Research contends that adults should get at least seven hours of sleep. This varies, of course, from person to person and according to the sleepers age, but the body will rest as it should as long as you keep a regular schedule of proper diet and exercise. In turn, youll be actively promoting quicker recovery, better blood flow, and improved focus, all from under the covers.

Warming up is an obvious preventative step. At the same time, it can be a big pain in the butt.

Everybody remembers those half-hearted first 10 minutes of gym class and/or practice, lackadaisically limbering body parts before the real play could begin. Dedicate yourself to active stretching, and you can flip that half-assed practice and not only help avert injury, but improve performance.

Elite movement coaches have found increased athletic achievement in concert with fewer injuries with targeted, non-repetitive, and dynamic stretching before, during, and after workouts. Straining muscles by elongating instead of flexing will have the same effect: youll get better movement and stronger, more defined musculature.

In turn, this can level up your pickleball game. A broad 2010 comprehensive analysis found that warming-up enhanced athletic execution in 79 percent of the criteria examined over several studies.

Core muscles your abs, inner and outer obliques, the diaphragm on top, and pelvic floor on the bottom stabilize your body as you bend, stretch, jump, and leap toward, say, yellow Wiffle balls on the pickleball court. It stands to reason that the more control you have over your extremities, the better shape your body is going to be in at the end of the activity.

Stabilizer, mobilizer, and load transfer core muscles assist in understanding injury risk, assessing core muscle function, and developing injury prevention programs, a National Library of Medicine paper concluded. Moderate evidence of alterations in core muscle recruitment and injury risk exists. Exercise programs to improve core stability should focus on muscle activation, neuromuscular control, static stabilization, and dynamic stability.

Similar to stretching, core workouts not only can help you prevent a strained back or pulled hamstring, but they can also boost your athletic capacity.

Whacking a plastic ball with a short, wood and graphite paddle might seem easy enough to do without practice, but that repetitive, chaotic motion can take a serious toll, especially if youre not doing it right.

Tennis elbow tendinitis that flares up when you dont warm and swing your arm correctly can affect pickleball players just as much as their hardcourt brethren. Seeing as tennis elbow can linger for six to 12 months, this is a common injury youre going to want to avoid. Knowing how to properly swing your paddle is key. For new players, break into the sport easily. Its no fun waking up with sore elbow tendons that could signal stepping away from the sport for a half or full year.

Mount Sinai Hospitals orthopedic department suggests balanc(ing) your body weight without over-extending your arms, legs, or your back. Use proper footwork to help you avoid injuries to the ankle and the Achilles tendon. Play with the proper equipment for your size and ability.

Pickleball, like any sport, can be a blast. Competition fires adrenaline, endorphins, testosterone, and other critical hormones. Whats good for the body is just as good for the mind. Theres no reason to get too excited, though. Youve got a lifetime to smack balls around. Make sure that youre prepared and on point to not only prevent injury, but give the game the best you got.

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Can Sustainable Initiatives Benefit Your Team’s Mental Health As Well As The Environment? – MinuteHack

Posted: September 16, 2022 at 2:13 am

Sustainability in its truest sense is much more than just being about the environment. It is also about the sustainability of professions and individual companies. A truly sustainable company has good team retention and the individuals in the team flourish because of the positive environment of the team.

The senior managements role in a business is to set the culture and strategy and be the encourager and enthusiast in the business. Its to help the wider team to decide what the values to live by are.

In the narrower sense, of course, we understand it as how businesses can help the environment. OneHealth is a current concept that is creating waves in the veterinary and medical world and suggests how all health must be viewed holistically. Health in mind and body and including the animals in our world and the environment all add up to give a sum greater than its parts.

There is increasing evidence that access to nature is good for physical and mental health. Research has shown that people experiencing stress can use green and blue spaces to improve well-being through walking and exercise.

In a recent webinar at The Webinar Vets 10th annual virtual congress, Dr. Catriona Mellor, a psychiatrist, introduced the concept of solastalgia which can be defined as a form of emotional or existential distress caused by negative environmental change or worrying about what may happen in the future to our planet.

When employees can see that their company cares about the planet and is making positive steps to improve local and international areas then this will help them realise that improving our planet is still possible if enough people, individually and corporately, make an effort. It takes the employee in the opposite direction to solastalgia. When companies have clear targets for becoming carbon neutral or being accredited by Investors in the Environment or the Carbon Trust, employees feel that the business exists for more than just making a profit but to help all stakeholders including themselves and the environment.

Planting wildflowers at the workplace on waste pieces of ground or where more traditional gardening has been previously, been will encourage wildlife like butterflies and bees. Preparing this area and seeing the beautiful flowers growing, gives people a sense of achievement and also helps to slow them down when they want to study the flowers and animals that thrive there.

The benefits of appreciating nature have become so well recognised that GPs have begun green and blue prescribing under the banner of social prescribing.

A recent article in the Wildfowl and Wetland Trusts magazine, Waterlife discussed five ways to well-being wellbeing in nature:

In the Lancashire Wildlife Trusts spring 2022 magazine, Lapwing, it was noted that green and blue social prescribing to a group of people suffering from loneliness, depression and anxiety delivered 6.88 of value to participants and the wider society for every 1 spent. There are many of these schemes springing up in North West England. As a vet, Im a big believer in preventative medicine. Spending time in nature as part of a companys sustainability activities or as an individual will protect the person from beginning to feel depressed or anxious.

When I am feeling stressed or sad, I often jump on my bike and cycle along the River Mersey amongst the dunes of Waterloo and Hightown. I enjoy the sights and sounds of the sea and the beautiful plants and animals that live at the coast as well as exercising and keeping myself fit. I can recommend it!

Anthony Chadwick is founder and CVO of Alpha Vet International

Anthony Chadwick BVSc CertVD MRCVS qualified from Liverpool University in 1990 and received his certificate in Veterinary Dermatology in 1995 from the Royal College of Veterinary Surgeons. Anthony was involved in first opinion practice and dermatology referrals until 2016. In 2010 Anthony set up The Webinar Vet, the first online training platform for veterinarians and nurses, in an attempt to make veterinary education more accessible and affordable across the world.

Since that time tens of thousands of veterinarians and nurses have accessed the platform from all over the world. The Webinar Vets first virtual conference took place in 2013. During the pandemic, The Webinar Vet helped to take over 40 veterinary meetings and conferences online including WVAC2020 and WCVD9.

In 2021, Anthony took the business carbon negative, helping to stand by The Webinar Vets principles of being as sustainable as possible and delivering exceptional quality training, internationally via remote means. The Webinar Vet is an Investor in the Environment Green Accredited business.

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Opinion: From the Great War to the pandemic, doctors and nurses have always carried a heavy burden – The Globe and Mail

Posted: September 16, 2022 at 2:13 am

Four stretcher-bearers and three replacements carry a wounded man through the shattered Passchendaele landscape.Four stretcher-bearers and three replacements carry a wounded man through the shattered Passchendaele landscape./CEF official photograph

Tim Cooks most recent book is Lifesavers and Body Snatchers: Medical Care and the Struggle for Survival in the Great War.

When I was diagnosed with Hodgkins lymphoma cancer in 2012 at the age of 40, I was told to down tools and concentrate on my health. It seemed like good advice, so I did just that. I stopped writing and instead focused on being well. I did some yoga. I tried breathing exercises. I practised mindfulness. I sent mantras out into the universe.

After a short period, I went back to research and writing, something I had been doing for almost 20 years as a public historian. I had concluded that cancer takes and takes, often until there is nothing left. I did not want it to extinguish the writer in me.

So I researched, and read and wrote as I was being poisoned and irradiated, losing myself in the past to give myself a future. Over a two-year ordeal that included multiple rounds of chemotherapy and radiation, and two stem-cell transplants, the cancer was destroyed.

During this test, as I read history books in the cancer ward in preparation for a two-volume history of Canada and the Second World War, I found that many of my oncologists at the General Hospital in Ottawa were not only interested in my research, but they had their own stories about medical practices that came about during wartime. Memorably, one doctor gave me an impromptu lecture on how mustard gas in the Great War had led to the development of certain chemotherapies. I was both fascinated and horrified.

I was also intrigued that so many medical practitioners saw themselves as part of a long continuum of caregivers, and I thought, in a vague way, that it might be nice to write a book about military medicine and one day present it to some of the doctors and nurses as a gesture of thanks. But I had other books to write, and it was not until 2020 that I returned to the subject of military medicine.

Lifesavers and Body Snatchers: Medical Care and the Struggle for Survival in the Great War, by Tim CookHandout

All books have their own history, and my latest history book is no different. I started what would become Lifesavers and Body Snatchers: Medical Care and the Struggle for Survival in the Great War in April, 2020. While research takes us into many unexpected places, I began with the devastating pandemic of 1918 to 1920, and how Canadians dealt with the invisible death 100 years ago.

How could I not as everyone was living through, and struggling with, the current pandemic that was sweeping the globe? The virus from 1918 to 1920 killed about 55,000 Canadians but had been largely forgotten until we faced our own iteration of this life-changing crisis. It was a topic worthy of study.

And yet the medical battles of the Great War went far beyond the virus and Canadian doctors and nurses played a crucial role in the terrible attritional war of 1914 to 1918. Half of all Canadian doctors and a third of the countrys nurses served in uniform, caring for the 620,000 Canadians who also left their loved ones to fight against the Kaisers forces.

So many medical practitioners were drawn into the vortex that Canadians at home suffered shortages of doctors by the midpoint of the war an intolerable doctor famine, as it was labelled in one medical journal. There was talk of conscripting doctors for service in Canada and redistributing them against their will across the nation. It did not happen, but the situation was desperate as the war overseas drew in medical personnel like a sucking chest wound.

And we needed every single one of them. Throughout centuries of warfare, almost every army saw more soldiers die from bacteria and viruses than from bullets and shells. During the Great War, doctors helped keep the fighting forces from withering away from disease and illness, a crucial act of force protection as thousands of Canadians fought amid the slurry of mud and filth in Western Front trenches populated with rats and rotting corpses.

Doctors impressed on the military high command the need to instigate mandatory vaccines against smallpox and typhoid. These vaccinations saved lives. The British, who initially had a voluntary system of vaccination, suffered comparatively more losses to disease. As a Canadian doctor wrote of those soldiers who refused vaccination and were removed from service: He was not allowed to endanger the health of his comrades.

Several thousand Canadians still died from disease in the putrid mire, but the great killer during the war was the devastating effects from artillery, machine guns, rifles, mortars and chemical weapons.

Canadian surgical team of two nurses, a surgeon, and an anesthetist work on a wounded soldier from the Battle of the SommeCanadian surgical team of two nurses, a surgeon, and an anesthetist work on a wounded soldier from the Battle of the Somme/Courtesy of Tim Cook

A Canadian doctor, Lieutenant-Colonel Walter Langmuir Watt, wrote of the carnage: Wounds here, wounds there, wounds everywhere. Legs, feet, hands missing; bleeding stumps controlled by rough field tourniquets, large portions of the abdominal walls shot away; faces horribly mutilated; bones shattered to pieces; holes that you could put your clenched fist into, filled with dirt and mud, bits of equipment and clothing, until it all became like a hideous nightmare.

To meet the horror, doctors devised new surgical treatments. The nefarious effects of infection that seethed in most wounds killed countless thousands in the age before antibiotics, with French, British, German and all other surgeons experimenting with means to eradicate the infections. A solution was to remove great swaths of flesh from ripped-open bodies, hoping to cut out the infection, while irrigating wounds with saline and chemical solutions.

If that did not work, amputation was often the only alternative. Colonel J.M. Elder, a prewar surgeon in Montreal, noted that he and other doctors overseas struggled to strike a just balance between the saving of a limb and the saving of a life.

Nine out of 10 wounded Canadians who reached a surgeon survived. Obscured in those statistics are the many tens of thousands of wounded who died in a smoking shell crater or disappeared into the mud of the many battlefields, dying alone and in agony.

To save lives required a constant learning process. When a study revealed soldiers dying of shock, doctors experimented with blood transfusions, with Canadian practitioners acting as pioneers among the Allied forces. By 1918, the last year of war, it was common to infuse the grievously wounded, in patient-to-patient transfers of life-giving blood.

X-rays were used extensively for the first time in war, assisting surgeons as they navigated the savagely pulped organs peppered with metal and shattered bones.

Invisible wounds to the mind, labelled broadly as shell shock, were particularly troubling to the high command that watched with concern as soldiers broke under the strain. The medical services were ordered to reduce losses and return soldiers to the front. New psychiatric approaches, including rest and talk therapy were mixed with electric shock therapy.

As I research and wrote the book, reading about our contemporary caregivers within the hard-pressed medical system in Canada, I was more aware of the emotional burden that lay heavy on the nurses and doctors of the Great War.

I am witnessing terrible suffering, wrote nursing sister Sophie Hoerner of the patients in her Canadian hospital behind the Western Front. Nursing sister Elizabeth Paynter recounted the agony of administering care to young men with terrible wounds, hoping they would recover: Another patient died, and another still was very low, while there were at least four other delirious head cases, who seemed to take turns pulling off their dressings or getting out of bed.

Other nurses wrote last letters to next of kin, telling them of a son, father or husband who would not be returning home, seeking to soften the blow with a personalized note or in sharing a last sentiment.

How could one read of the nurses who held the hands of young Canadian soldiers whispering for their mothers as they breathed their last breath and not weep from thinking about what was happening in our COVID-19 wards patients dying without their loved ones, usually with only nurses and doctors to bear witness?

Through 2020 and early 2021, writing history that was connected to the contemporary medical crisis kept me going, a shield against the sheer awfulness of COVID with its physical threat and mental attrition that seemed to have no end.

Of course, for the generation that lived through the Great War, they too could see no end to the slaughter. They too believed it would be a forever war.

But the guns finally went silent on Nov. 11, 1918, and, like all great catastrophes, there were powerful legacies. In the field of medicine, as thousands of doctors and nurses returned to their communities, battlefield innovations were mapped on to civilian care.

X-rays were employed to assist those with tuberculosis, the great killer of Canadians aged 18 to 45 in the early 20th century.

Blood transfusions saved lives, with pioneers like Lawrence Bruce Robertson taking the lessons of infusing dying soldiers on the Somme to assist burn patients at Torontos Hospital for Sick Children.

To engage more fully in preventative care, a new Department of Health was created in 1919. It aligned with the desire of Canadians and medical practitioners to prevent disease instead of simply treating it. The success of soldiers wartime vaccinations in reducing losses to disease and the revelations of the poor health of tens of thousands of malnourished men turned away from service further drove the need for change.

There is nothing like a war to discover the steps that should be taken for the protection of public health, mused one influential Canadian senator.

There were advances in physiotherapy for the thousands of veterans who were grievously wounded, developments in psychology (although treatment remained deeply contested), and even a new emphasis on maternal care with the message of needing to save the lives of babies to replace the 66,000 Canadian soldiers killed during the war. In Montreal at the turn of the century, for instance, one in four babies had died before their first birthday, a horrendous indictment of the lack of public health in Canada.

Out of the welter of this terrible war, wrote one Canadian physician, with all its misery and suffering, will emerge as some small measure of compensation a fuller knowledge of the prevention of disease, the treatment and cure of sickness and wounds and general surgical conditions, which knowledge will be used by the medical profession to the great benefit of living humanity and generations yet unborn.

Lifesavers and Body Snatchers is not about our current pandemic, but, as with most history books, the present bleeds into its pages.

I was excited about a book tour in September to speak about my findings and to hear the reaction from readers. Those plans were laid to waste when cancer struck again.

It is a different cancer than 10 years ago. And after a brief pity party, I prepared for battle. I told myself that I was, perhaps, better equipped than some for the trial ahead, a veteran of past fights and grounded in the long view provided by history.

I marched forward, head down, hoping to make the hard yards. The battle plan saw radiation and chemo in the summer, and then surgery some time in September.

I met daily the doctors and nurses who treated me with care, compassion and skill. Some were interested in the new book; others looked too harried to have much time to read. I hope they do. There are lessons from the Great War on what nurses and doctors did in a time of great crisis and mass death, with no end in sight for those caught in the storm. It might bring some comfort to those medical workers today as our health care system is on the brink of breaking under unyielding strain.

For me, I hope to survive and be on the road again talking about my work. In the meantime, I will keep writing to cope and endure, and to find meaning in the past to provide guidance in the present, and some hope for the future.

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Opinion: From the Great War to the pandemic, doctors and nurses have always carried a heavy burden - The Globe and Mail

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Management of Chronic Migraine in Children and Adolescents | PHMT – Dove Medical Press

Posted: September 16, 2022 at 2:13 am

Introduction

Migraine is a primary headache disorder affecting up to 7 million children and adolescents in the United States.13 Females are disproportionately affected by migraine, and the prevalence of the disease increases over the course of development.4,5 The impact of migraine on quality of life among children and adolescents is comparable to that of other chronic illnesses such as rheumatic disease and cancer,6 and unfortunately, migraine tends to persist into adulthood.7

Chronic migraine is a subtype of migraine that affects approximately 12% of youth,5 and is typically characterized by a gradual progression (ie, chronification) of episodic symptoms over the course of weeks or months.8 Youth with chronic migraine may experience co-occurring medical concerns for which subspecialty care may be required, including abdominal or musculoskeletal pain complaints, clinically significant sleep disturbances, and other neurological conditions such as epilepsy.9 Children and adolescents with chronic migraine often report substantial impairment in school-related functioning,10,11 challenges related to engaging in leisure activities and spending time with friends,12 and difficulties in family relationships.13,14 Thus, the management of chronic migraine in children and adolescents requires a holistic, integrative, and multimodal intervention approach that incorporates both medical and non-pharmacological treatments to address the symptoms and functional impairment associated with this debilitating headache disorder.

The purpose of this narrative review is to provide an overview of current best practices for acute and preventive treatment of chronic migraine in children and adolescents, direct attention to the most recent developments in the field, and emphasize important avenues for clinical research. In this review, we use guidelines set forth by the American Academy of Neurology (AAN) and the American Headache Society as frameworks to highlight treatments that represent the current standard of care for pediatric patients with chronic migraine and identify relevant gaps in intervention research. We then highlight treatment options that are currently receiving rigorous clinical research attention, provide a discussion of novel directions for research focused on improving existing interventions for chronic migraine in pediatric populations, and describe targeted research strategies that may expand access to evidence-based care for these patients and their families.

Accurate diagnosis of chronic migraine requires thorough physical and neurologic examinations and assessment of headache history including pain location(s), headache frequency, severity, and associated symptoms. The diagnosis of migraine and chronic migraine is made in accordance with the International Classification of Headache Disorders, 3rd edition (ICHD-315) criteria. Accurate diagnosis typically requires a recorded history of headaches and symptoms that occur during an attack using a headache diary.

The majority of treatment-seeking patients present with migraine or probable migraine; a diagnosis of probable migraine may be assigned when a patient meets all but one of the ICHD-3 diagnostic criteria for migraine. As Table 1 highlights, migraine is characterized by headaches of moderate-to-severe intensity that are accompanied by nausea, vomiting, photophobia, and/or phonophobia. The primary differentiating feature between youth with migraine and chronic migraine relates to headache frequency, as youth diagnosed with chronic migraine must experience 15 or more days with headache per month for at least 3 months, and the majority of these headaches must have migraine features.15 Some patients experience an aura (ie, a warning signal) with their migraine, which include visual, sensory, motor, and other central nervous system disturbances that precede headache onset.

Table 1 International Classification of Headache Disorders (ICHD-3) Diagnostic Criteria for Migraine without Aura and Chronic Migraine

Some children and adolescents also present with chronic tension-type headache (CTTH), a headache disorder in which the frequency of headache episodes is similar to that of chronic migraine. However, patients with CTTH typically do not experience migraine features such as photophobia, phonophobia, and severe nausea or vomiting, and their headaches are typically not as severe in intensity. In rare cases, youth may present for treatment with new daily persistent headache (NDPH), a primary headache disorder characterized by a rapid onset of unremitting headache. Patients with NDPH may or may not have migraine features with their continuous headache. Patients often recall the date their unremitting headache began due to its abrupt onset, and therefore do not endorse a history of increasing headache frequency. Chronic migraine can also be characterized by daily or continuous headache presentations; however, this presentationas highlighted abovetypically occurs via gradual chronification of headaches over time.

One other type of continuous headache presentation is hemicrania continua. Patients with this headache disorder may experience migraine-like symptoms with their continuous headache, but their pain is isolated to one half of the face and head with ipsilateral autonomic features such as conjunctival injection or with agitation, and the headache is responsive to one particular drug (indomethacin). This is incredibly rare in youth16 but is important to consider in those with unremitting unilateral pain that is refractory to treatment. Similarly, clinicians should consider idiopathic intracranial hypertension as a possible diagnosis for pediatric patients, as these youth most commonly present with intermittent diffuse headache that often occurs with migraine-like symptoms such as nausea and vomiting. However, IIH is most clearly identified by the presence of papilledema, significant visual disturbances (eg, blurred or double vision), tinnitus, and neck stiffness.17

Once a chronic migraine diagnosis has been established, a biopsychosocial approach to care that incorporates both medical treatment and non-medicine intervention strategies is recommended. The gold-standard biopsychosocial intervention plan incorporates acute treatment, preventive treatment, healthy lifestyle habit recommendations, and relaxation and/or cognitive-behavioral interventions. Goals of treatment include reducing headache frequency, reducing disability associated with headaches, and improving the child or adolescents quality of life.18 The following subsections will review each of these treatment components in more detail, and a summary of the reviewed acute and preventive treatment options is presented in Table 2.

Table 2 Summary of Reviewed Acute and Preventive Treatment Options for Chronic Migraine in Children and Adolescents.

One challenge that can complicate a child or adolescents diagnostic picture and treatment planning relates to use of acute medications. Some youth with migraine can experience headache chronification related to overuse of analgesic or headache rescue medications (see Acute Treatments section for more information). Medication-overuse headache (MOH) can be diagnosed if a patient with a pre-existing primary headache disorder (eg, migraine, chronic migraine) uses acute medication on 10 or 15 (depending on the medication) or more headache days per month for more than 3 months. Research suggests that approximately half of youth with chronic migraine overuse acute medications to manage their symptoms.19

According to ICHD-3 criteria, a diagnosis of chronic migraine should still be assigned even if a patient also meets criteria for MOH. This is notable because epidemiologic studies have shown that the estimated prevalence of chronic migraine decreases from approximately 2% to roughly 0.8% when children and adolescents with MOH are excluded.19 Thus, it is imperative to diagnose MOH where appropriate to guide appropriate treatment planning and counseling. For patients with comorbid chronic migraine and MOH, a comprehensive acute medication weaning plan should be established. An emphasis on prevention therapy is also especially important for patients with MOH.20

The purpose of acute migraine treatment is to ameliorate pain and associated symptoms that occur during an attack, minimize side effects, and facilitate a return to typical functioning as quickly as possible.21 Headache specialists work with school systems and caregivers to ensure that children and adolescents are able to access acute treatments in school and at home to treat headaches at onset and minimize the disruptive impact of migraine on daily life. The most recent (2019) guidelines from the AAN emphasize early intervention that is tailored to the specific features of an individuals headache attack.22

The most commonly studied and prescribed acute migraine medications generally fall into three categories: nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen), analgesics (eg, acetaminophen), and the migraine-specific triptans (eg, sumatriptan). In addition, novel therapies known as gepants and ditans are used in adults and will be discussed later. Current evidence supports use of ibuprofen as an initial treatment for both children and adolescents experiencing an acute migraine attack. Naproxen and diclofenac are commonly used as well, though with less objective evidence for their efficacy. Oral sumatriptan plus naproxen or almotriptan may be also be prescribed for adolescents aged 12 and older. For patients who cannot tolerate oral formulations, sumatriptan and zolmitriptan are United States Food and Drug Administration (FDA) approved in nasal spray formulations for ages 12 and older. Of the seven triptans available, rizatriptan is the only FDA-approved triptan for use in children down to age 6.

Antiemetic treatments should also be offered for youth who commonly experience nausea and vomiting with migraine, as none of the available treatments demonstrate significant efficacy for treatment of these symptoms.22 Dopamine antagonists such as prochlorperazine, chlorpromazine, promethazine and metoclopramide have pain relieving attributes in addition to their antiemetic characteristics23 but patients should be warned about the potential for extrapyramidal side effects such as muscle stiffness, akathisia or agitation which is more common with recurrent use, in younger patients, and among those already taking antidopaminergic agents.24 Finally, ondansetron has not demonstrated pain relief but may be considered for those with prior adverse reaction to antidopaminergic agents or other contraindications to them.25 It is generally safe but may cause QT prolongation and dysrhythmia, especially with recurrent use.26

Because overuse of triptans and analgesics can be associated with MOH27 and migraine chronification,28 clinicians should recommend that all abortive medications be used on no more than three headache days per week21 and triptans be used no more than 2 days per week.29 There are currently no evidence-based recommendations to guide treatment of MOH in children and adolescents. In clinical practice, management of MOH may include abrupt cessation or weaning of acute medications with immediate or later initiation of preventive therapy.30 A 6-week washout period of all acute medications has been shown to result in recovery of specific gene expression changes related to medication overuse.29,31

Given that pill-based therapies can be associated with the development of medication overuse headache and migraine chronification, considerable clinical research effort has been dedicated to the development of nonpharmacologic treatment options for acute migraine management. Neurostimulation (also termed neuromodulation) has gained attention in the adult migraine literature as an alternative approach to migraine management for patients who do not respond to available pill-based treatments. Neuromodulation aims to inhibit pain signaling by delivering electrical impulses to nerves involved in sensory processing and pain perception. A number of non-invasive (eg, single-pulse transcranial magnetic stimulation or vagal nerve stimulation) and invasive (eg, occipital nerve stimulation) techniques have been developed and tested in adults with migraine, and these are generally associated with fewer side effects relative to traditional pharmacologic treatment options (see32 for review). The following two devices are FDA-cleared for use in adolescents with migraine.

A non-invasive vagus nerve stimulation (nVNS) device is FDA approved for acute and preventive therapy of migraine and other headache disorders in adults and adolescents over age 12. The device is held at the neck for two cycles of 12 minutes, which can then be repeated after 20 minutes and again after 2 hours if needed. A small open-label study by Grazzi et al33 showed that nearly half (46.8%) of attacks were effectively treated without need for rescue medication and did not report any device-related adverse events. This pilot study provides the foundation for larger studies of nVNS for acute and preventive migraine therapy in adolescents.

Recently, an open-label study conducted by Hershey et al34 examined the safety, tolerability, and initial efficacy of a remote electrical neuromodulation (REN) device for treatment of acute migraine attacks among adolescents with migraine. This sample included a subset of participants who met criteria for chronic migraine based on their number of monthly headaches with migraine features. In the study, participants used the REN devicewhich was worn on the lateral upper armto deliver electrical stimulation during four migraine attacks over an 8-week period. Results showed that use of the device was not associated with any significant adverse events or participant study withdrawal; 71% of the participants experienced pain relief and 35% achieved pain freedom within 2 hours of symptom onset. Sustained pain relief was demonstrated among 90% of the participants at 24 hours. These preliminary data resulted in FDA clearance for use among adolescents for acute treatment of migraine.

Further studies are underway to assess the utility of the REN device in the Emergency Department setting, and others are being planned as a preventive option. Though preliminary, the promising findings discussed above suggest that the safety and efficacy of REN should be tested in a larger, randomized placebo-controlled trial to determine whether this acute treatment option could be integrated into routine clinical practice, or even in the Emergency Department setting for youth with chronic migraine, particularly those who present with comorbid MOH.

Counseling patients about the roles of lifestyle and behavioral factors that reduce the likelihood of headaches occurring is a primary emphasis of preventive care. Inadequate hydration, skipping meals, poor sleep, and insufficient exercise are factors associated with increased headache risk.35,36 Conversely, engaging in routine aerobic activity, eating regular meals, getting sufficient sleep, and obtaining sufficient daily fluid intake can reduce headache frequency and intensity.3739

Recently, Robblee and Starling40 published practical guidelines for clinicians with detailed information about lifestyle factors that promote migraine prevention. These guidelines recommend that clinicians provide patients with guidelines about obtaining a sufficient number of hours of sleep for their developmental stage (eg, 912 hours for school-age children; 810 hours for teenagers); practicing good sleep hygiene (eg, maintaining a consistent sleep-wake schedule, discontinuing use of electronics 3060 minutes before bedtime; and practicing a consistent bedtime routine that can incorporate relaxation practices); maintaining a healthy and well-balanced diet that includes protein, leafy green vegetables, and fruit; avoiding skipping meals; engaging in regular aerobic exercise; and obtaining adequate daily fluid intake. For teenagers with chronic migraine, between 80 and 100 ounces of fluid per day is recommended.

A variety of medications are currently used for pediatric migraine prevention, and include antidepressants (eg, amitriptyline), antiepileptics (eg, topiramate, gabapentin), and calcium channel blockers (eg, flunarizine).41 One preventive medication that is frequently used as a first-line drug therapy is amitriptyline, which is a tricyclic antidepressant that has shown to be effective in reducing headache frequency and disability in children while minimizing side effects when titrated slowly.42 Topiramate, a drug of the anticonvulsant class, is the only FDA-approved pediatric preventive migraine medication. Although topiramate has been shown to reduce headache frequency in youth,22,43 it is associated with more side effects than amitriptyline.44 Valproic acid, another anticonvulsant, has shown efficacy in youth with migraine, but its teratogenic (class X) and ovarian effects limit its use in females.45

Practice guidelines emphasize a 50% reduction in headache frequency as a benchmark for which the effectiveness of a preventive treatment can be evaluated. That all said, it should be noted that the largest comparative effectiveness trial of preventative medication for youth with migraine to datethe Childhood and Adolescent Migraine Prevention (CHAMP) trialwas discontinued early due to futility after interim results revealed that amitriptyline and topiramate were not superior to placebo in reducing headache days.44 Results from this study showed that up to 70% of youth in both the active drug and placebo groups exhibited a 50% reduction in headache days over the course of the trial. Further, meta-analytic evidence has demonstrated that there are limited data to support use of medication alone as an effective preventive treatment for youth with chronic migraine.46 These findings have led to an increasing call for pediatric headache providers to promote behavioral treatments as frontline preventive interventions.

The best available evidence, as described in current guidelines from the AAN and American Headache Society, supports use of a combined pharmacotherapy (ie, amitriptyline) and behavioral approach (ie, cognitive-behavioral therapy) for migraine prevention in children and adolescents. These recommendations were created after a large randomized controlled trial demonstrated that the combined treatment with cognitive-behavioral therapy (CBT) and amitriptyline was superior to amitriptyline and headache education in reducing youth headache frequency by at least 50% (from a baseline average of 21 headache days per month to approximately 10 after 20 weeks).47 An ancillary analysis from this trial revealed a linear trend and quadratic trend in headache day change, indicating that although decreases in headache days continued throughout the trial, the majority of clinical improvement occurred by the 8-week time point in the CBT+AMI group.48 These data suggest that these youth make relatively rapid treatment gains that can be sustained over time. The evidence base for CBT for pediatric migraine prevention continues to grow; a 2018 Cochrane review of all published clinical trials concluded that CBT is effective in reducing headache days and headache-related disability among youth with migraine.49

CBT is a skills-oriented treatment that provides training in coping techniques and behavioral strategies that can be applied to manage and prevent headaches.50,51 Typically, treatment begins with headache education and an introduction to the gate control theory of pain.52 In the initial stages of treatment, the therapist reviews family guidelines with youth and their caregivers; these guidelines offer practical steps to support the childs pain management and address family factors that may interfere with the patients daily functioning or increase their focus on current symptoms. Patients then receive instruction and practice several relaxation exercises including diaphragmatic breathing, progressive muscle relaxation, and guided imagery. These techniques decrease autonomic arousal and muscle tension that can be associated with pain, and serve as a means of distraction from symptoms. Relaxation training may be used in conjunction with biofeedback technology to allow youth to see for themselves how practicing relaxation skills results in physiological changes such as increased peripheral body temperature and decreased muscle tension.

Psychologists providing CBT also facilitate activity pacing and adherence to healthy lifestyle recommendations through instruction and collaborative problem-solving. This additional layer of intervention may be especially important given that youth with migraine frequently report difficulty with adherence to medical recommendations related to eating and hydration.53 Finally, cognitive reappraisal skills are provided to teach youth how thoughts and feelings are connected to the pain experience, and challenge negative or unrealistic thinking that can contribute to worsening pain and associated symptoms.

Despite the growing evidence base for CBT as an effective intervention for pediatric migraine prevention, it is important to consider that it is not a one-size-fits-all treatment, and may not meet the needs of each patient with chronic migraine. For example, although a majority of youth with migraine do not meet criteria for a co-occurring psychiatric disorder,54 children and adolescents with migraine are more likely than youth without migraine to report elevated internalizing symptoms (eg, anxiety, depression), attentional difficulties, and somatic complaints.55 Furthermore, the presence of co-occurring clinically elevated depressive or anxiety symptoms is associated with greater disability and diminished quality of life in youth with migraine.56,57 Thus, routine screening for co-occurring psychiatric comorbidities and appropriate follow-up should be routinely provided in specialty headache centers. If a clinically significant psychological disorder is detected in this assessment process, it should be considered a treatment priority.

The severity and disabling nature of chronic migraine in youth also presents numerous challenges for which traditional CBT may not promote effective management of symptoms. For example, some children and adolescents with chronic migraine have undergone several trials of preventive medication with varying success, and may therefore have different beliefs about how to best manage pain, what to expect from treatment, and goals for treatment relative to youth with less frequent or disabling headache presentations. The primary aim of CBT for migraine is to improve a patients functioning while reducing the frequency of symptoms. Other interventions may be needed to more specifically target disability and psychological factors that can impact day-to-day functioning in this patient population.

Third-wave psychological interventions, such as Acceptance and Commitment Therapy (ACT) and mindfulness-based approaches, focus primarily on increasing patients psychological flexibility and engagement in activity that they value as opposed to focusing on decreasing their pain or symptoms. Mindfulness, which is a core component of ACT, is derived from Buddhist spiritual traditions and involves bringing attention to the present moment, adopting a nonjudgmental, accepting stance about pain and symptoms, and flexibly adapting to daily fluctuations in pain and symptoms.58 The evidence for ACT in the treatment of pediatric chronic pain is growing.59 Two investigations of mindfulness-based interventions for chronic migraine in children and adolescents, including one recent open-label trial, have shown promising results in reducing migraine-related disability,60,61 mirroring findings from trials of mindfulness-based interventions among adults with migraine.62,63

Clinical research efforts have been devoted to studying alternative treatments that reduce risks associated with traditional pill-based migraine therapies given current practice guidelines. What follows is a discussion of alternative treatment options that have been studied extensively in adults with migraine, and may be recommended for pediatric patients who have not responded to available preventive treatments.

Youth with chronic migraine and their families often request trials of dietary supplements or nutraceuticals as alternative pill-based treatment options. Nutraceuticals, which are compounds derived from foods such as fruits and vegetables, are a form of complementary and integrative medicine (CAM) and are among the most commonly used treatments among pediatric patients with chronic pain conditions, including migraine.64 Despite the popularity and widespread use of nutraceuticals in pediatric pain populations, there are no practice guidelines regarding their use for acute migraine treatment or prevention.

Orr65 published, to our knowledge, the only existing review of nutraceuticals for the treatment of migraine in youth. The review summarized results from 11 observational studies, seven randomized controlled trials, and three systematic reviews. The reviewed nutraceuticals included vitamin D, riboflavin, coenzyme Q10, magnesium, butterbur, and polyunsaturated fatty acids. The review concluded that, given the relative absence of rigorous clinical trials, there is limited evidence for the efficacy of nutraceuticals for migraine prevention and acute treatment in children and adolescents. Coenzyme Q10 has demonstrated initial efficacy for migraine prevention compared to placebo, and oral magnesium may reduce pain intensity when acute headaches are treated with ibuprofen or acetaminophen. However, in the absence of clear, rigorous safety and efficacy data for nutraceutical use, clinicians should discuss with their patients that there is currently no evidence that these treatments are superior to placebo.

Orr65 also informs clinicians about differences in regulatory practices between pharmaceuticals and nutraceuticals, and encourages providers to educate patients about risks associated with nutraceuticals given the frequent assumption that they are safe if available without a prescription.66 For example, butterburwhich has a long history of use in adults with migraine and has been recommended in guidelines from the American and Canadian Headache Societieshas hepatotoxic properties and is generally not recommended for treatment of migraine among children and adolescents.65

OnabotulinumtoxinA (OBTA; ie, BOTOX) was approved in 2010 by the FDA for treatment of chronic migraine in adults. Data examining the efficacy of OBTA for treatment of youth with chronic migraine are limited. OBTA did not gain FDA approval in adolescents after failing to demonstrate greater efficacy compared to placebo.67 A later crossover trial of OBTA for treatment of youth with chronic migraine showed that, compared to a placebo group, youth who received a trial of OBTA injections administered in 3-month intervals and 6-week follow-up visits demonstrated a statistically significant decrease in migraine frequency and intensity, but not duration.68 Multiple retrospective reviews of outcomes for pediatric patients with chronic migraine who received treatment with OBTA after failing oral therapies showed a statistically significant reduction in headache days and disability, and that OBTA was well-tolerated.69,70 Current guidelines from the AAN state that there is currently insufficient evidence to support the use of OBTA for migraine prevention in youth. In practice, OBTA injections may be recommended when a patient with chronic migraine has not responded to two or more preventive therapies.

The calcitonin gene-related peptide (CGRP) is an amino acid peptide found in sensory fibers throughout the body, and particularly in the central nervous system. The CGRP pathway is involved in sensory processing and pain modulation, and has been implicated in the pathophysiology of migraine.71 In adults, antagonism of the CGRP pathway is associated with diminished headache days and medication usage.72 Monoclonal antibodies (mAbs) to CGRP or its receptorwhich require subcutaneous (erenumab, galcanezumab, fremanezumab) or intravenous administration (eptinezumab)have shown safety and efficacy in trials of adults with migraine,7377 some with open-label data for 1 to 5 years.78,79

To date, there are no published placebo-controlled trials of mAbs in children and adolescents with migraine. In 2018, Szperka et al published a set of recommendations for the use of anti-CGRP mAbs in children and adolescents with migraine.80 These guidelines emphasized that consideration of anti-GGRP mAbs should be limited to youth with a frequent migraine presentation and for whom established migraine preventive therapies have not been effective. These therapies should include oral treatments and may also include CBT, neuromodulation devices and nutraceuticals. The authors note that rigorous clinical research effort is needed to establish long-term safety and efficacy data for use of anti-CGRP mAbs in children and adolescents with migraine, and emphasize those youth with more severe migraine presentations (eg, continuous headache) should be included in future trials as these youth have the greatest need for targeted therapeutics.

Greene et al reported a multicenter retrospective study of children and adolescents treated with mAbs for chronic headaches including chronic migraine, persistent post-traumatic headache and NDPH.81 This report of 112 patients with nearly daily or continuous headaches was the first to provide safety and efficacy data in this group. Their data showed that side effects in adolescents are similar to those reported in adult trials and that mAb treatment may benefit youth who are otherwise refractory to other prevention therapies. Notably, severity of pain and functional status improved in more than half of cases. Several randomized controlled trials of mAbs in children and adolescents with episodic and chronic migraine are underway.

Newer targeted therapies known as gepants and ditans have made their way to market after decades of translational research. Gepants act as antagonists to calcitonin gene-related peptide (CGRP) receptors,82 while ditans likely act as agonists of the serotonin 5HT-1F receptors. In contrast to triptans, gepants and ditans do not cause vasoconstriction and are therefore safe for use in patients with history of cardiac or other vascular conditions including stroke.83 Rimegepant, ubrogepant and lasmiditan are currently FDA-approved for acute therapy in adults with migraine and studies are underway in children and adolescents. These drugs may therefore represent third- or fourth-line options for off-label use in youth with attacks refractory to other medications, or with contraindications or adverse reactions to triptans. Although no head-to-head studies have compared gepants and ditans to other pharmacologically active drugs, a meta-analysis showed that gepants and ditans were associated with a lower odds ratio than most triptans for pain relief or freedom at 2 hours.84

Rimegepant also recently gained FDA approval for migraine prevention in adults after showing superiority to placebo at reducing headache days in those with episodic and chronic migraine when dosed every other day.85 Adolescents who experience excellent and sustained (2448 hours) relief from headache with acute rimegepant use may be particularly good candidates for preventive therapy with rimegepant. In addition, atogepant is the only gepant with FDA approval solely for preventive therapy in adults with migraine. Finally, though not exclusively a pill-based therapy, zavegepant is currently being studied for prevention in its oral form and has evidence of efficacy for the acute treatment of migraine in its nasal form.86

Although there have been numerous advances in acute and preventive treatment over several decades, treatment of youth with chronic migraine continues to evolve. As highlighted in this review, available evidence suggests that pediatric patients with chronic migraine do experience a reduction in headache days when they receive multidisciplinary, biopsychosocially oriented intervention,87 and treatment gains made through preventive care are often maintained over time.88 Current practice guidelines for the prevention of migraine in youth emphasize a combined pill-based and nonpharmacological approach. We anticipate that a holistic approach to migraine management will continue to represent the best standard of care moving forward, even as considerable attention is being devoted to establishing an evidence base for the use of novel interventions such as neuromodulation, GGRP monoclonal antibodies, and targeted pill-based therapies for both acute and preventive treatment. In the following sections, we highlight important and novel avenues for advancing evidence-based care through future clinical research.

Despite the range of interventions that have been developed for the treatment of chronic migraine, additional research is needed to tailor available treatments for the clinical presentation and treatment needs of youth with chronic migraine and their families. Much of current clinical guidance has been gleaned from studies in adult patients; however, it has become increasingly apparent that children and adolescents with headache disorders can differ substantially from adults in terms of their responses to pharmacological treatments.

Given this, studies highlighted in this review underscore the importance of taking a developmental approach to research involving novel medical and nonpharmacological intervention approaches for youth with chronic migraine. As the field continues to evolve, prospective longitudinal research will be needed to advance our understanding of the developmental contributors to the progression and course of chronic migraine in children and adolescents. For example, epidemiologic studies have shown that pre-pubertal males have a higher prevalence of migraine relative to females, but there is a dramatic increase in migraine prevalence among females post-puberty.89 Prospective longitudinal studies that examine the roles of age and development (eg, puberty, hormonal changes) in relation to the presentation of migraine, or investigate neural changes associated with migraine progression may enhance our identification of targets for early intervention tailored to the needs of each individual. Further, given the strong link between genetics and migraine, studies identifying the monogenic and polygenic contributors to the pathophysiology of migraine disease are crucial as the field works toward precision medicine as a standard of care.31,90

The effectiveness of CBT for prevention of pediatric migraine also raises important questions about how and why this treatment approach works. Recently, our research group published an overview of psychological interventions for pediatric headache disorders,51 in which we discuss the role of mechanistic studies and their importance for elucidating neural alterations associated with CBT treatment. Research has demonstrated that pre-post CBT alterations in resting state brain activation and functional connectivity occur among youth with migraine who have received this intervention for headache.91 Our group is also conducting an ongoing mechanistic study (funded by the National Center for Complementary and Integrative Health and the National Institute of Neurological Disorders and Stroke) may be able to answer why patients with migraineincluding chronic migrainemake such rapid treatment gains in response to gold-standard preventive care by determining the extent to which components of CBT intervention are associated with particular neural changes among youth with migraine.

Empirical support for the treatment of migraine in youth is largely based on studies that have included patients recruited from specialty headache centers, patients who meet very specific diagnostic criteria, and patients without medical or psychiatric comorbidities. While this level of rigor in clinical trials increases our confidence in the benefit of available interventions, it is possible that the stringent nature of referrals from tertiary care clinics and inclusion criteria has resulted in many youth with chronic migraine being excluded from clinical trials, leaving a gap in our fields ability to conceptualize and understand which treatments work best for which patients. Furthermore, participants in migraine research studies tend to be predominantly White, female, and from upper middleclass backgrounds.92 Improving the representativeness and generalizability of our treatments will require prioritizing the inclusion of patients from underrepresented backgrounds in all aspects of the research process, from recruitment and retention to intervention development and dissemination of findings.

As discussed previously, a subset of treatment-seeking children and adolescents who meet the criteria for chronic migraine present with continuous (ie, unremitting) headache. Unfortunately, these patients are often excluded from research studies as they are considered to be much more complex in terms of their psychosocial profile and refractory to treatment relative to other youth with less frequent headache presentations. As the field moves forward, it will be important to recruit subpopulations of pediatric patients with chronic migraine experience continuous headache to determine their patterns of treatment utilization, preferences for treatment, and whether available treatments are also effective for patients with this headache presentation. Understanding the treatment priorities and goals of patients with more severe and disabling chronic migraine presentations may also lead to the development and testing of tailored interventions. It will be exciting to learn whether ACT and mindfulness-based approaches demonstrate efficacy for treatment of headache days and disability among youth with migraine, and whether principles of these treatments could augment traditional CBT intervention.

Population-based studies have shown that migraine is more prevalent among youth from lower socioeconomic (SES) backgrounds.93 Moreover, there are considerable racial and ethnic disparities in the prevalence of migraine. For example, in the United States, the prevalence of migraine is highest among Native Americans. These disparities reflect inequities in access to care and treatment practices that lead to poorer long-term health outcomes.94

An unfortunate reality stemming from differences in health equity is that many of the newer and investigational treatment options discussed in this paper, such as neurostimulation and anti-CGRP antibodies, are not consistently covered by third-party payors and have extremely high out-of-pocket costs. Access to adequate healthcare in the United States remains poor for many pediatric patients and their families, and this is a substantial barrier to evidence-based migraine treatment that has not improved in recent years. Indeed, a recent review published by Yu et al showed that percentage of children and adolescents experiencing underinsurance rose from 30.6% in 2016 to 34.0% in 2019.95 Even gold-standard preventive treatments, such as cognitive-behavioral therapy, are not consistently covered by insurance providers. The result of inequality in healthcare access is that under-resourced children and adolescentsthe young people who need the best available care the mostare not being seen for care in specialty headache centers. These children and their families understandably rely on the types of care that are available to them, and community clinics or hospitals may not employ neurologists with a specialization in headache medicine or pediatric psychologists who practice behavioral headache medicine.

One tangible approach that begins the process of addressing barriers to patients access to equitable care involves leveraging the potential of innovative study designs to expand the reach of evidence-based interventions. For example, a current study funded by the National Center for Complementary and Integrative Health (NCCIH U01 AT010132) is employing a multiphase optimization strategy (MOST;96) to develop a cognitive-behavioral intervention delivered by nursing staff in outpatient neurology clinics. The goal of this study is to identify which components and doses of CBT are most effective to promote change in key headache outcomes, with treatment being provided by healthcare professionals besides trained psychologists. The data gleaned from this study will inform the development of a large pragmatic or sequential multiple randomization (SMART) trial that will be conducted in neurology clinics and, in the long term, could also be conducted in primary care or pediatric practices. Expanding the availability of evidence-based pediatric behavioral medicine beyond secondary and tertiary care should be considered a priority as our field works to increase the accessibility of care for all patients and their families.

It is also crucial that clinicians and researchers continue to advocate for their patients as the field of pediatric headache medicine works toward a more equitable and inclusive scientific practice. The COVID-19 pandemic has exposed vulnerabilities in the healthcare system and further underscored racial and ethnic disparities in healthcare.97 Yet, the proliferation of telemedicine over the past 2 years perhaps represents an opportunity to rigorously study the efficacy of interventions that can be feasibility delivered remotely in the context of a pragmatic clinical trial. As the field works to expand care beyond specialty clinics, pragmatic trials may represent one clear opportunity to advance clinical practice and facilitate the successful dissemination and implementation of migraine treatment. For example, a trial examining the efficacy of CBT delivered entirely remotelyand casting a wide net to include patients with chronic migraine, including those who may have been historically excluded from trials (eg, youth with continuous headache)could facilitate the eventual integration of CBT into traditional clinical practice, thus increasing its accessibility to patients and families. If researchers can leverage the potential of innovative study designs to improve the availability of evidence-based care in a manner that allows patients to access it earlier, the field of pediatric headache medicine may be better positioned to prevent chronic migraine from progressing further and persisting into young adulthood.

Chronic migraine is a disabling migraine subtype that affects a substantial proportion of children and adolescents and tends to persist into adulthood. Over the past several decades, substantial gains have been made in advancing both acute and preventive treatments for this debilitating headache disorder. We have learned that a biopsychosocial approach to the conceptualization and treatment of migraine is most beneficial to patients, and current research is advancing our understanding about why nonpharmacological treatment strategies for migraine prevention work. As the field moves forward, considerable clinical research effort should focus on expanding access to evidence-based care, testing novel therapeutics, leveraging the potential of innovative study designs such as SMART and pragmatic trials to inform precision medicine and wider dissemination of interventions, recruiting patients for research studies who have traditionally been underrepresented, and tailoring existing nonpharmacological interventions to meet the unique needs of each child and their family. We believe the future of pediatric headache medicine is bright, and feel confident that the coming years will provide new insights into the optimal management of chronic migraine in children and adolescents.

This work was supported by R01 (R01AT010171) and U01 (U01AT010132) grants from the National Center for Complementary and Integrative Health, an R01 grant (R01NS101321) from the National Institute of Neurological Disorders and Stroke, and a training grant from the National Institute of Diabetes and Digestive and Kidney Diseases (T32DK063929).

Dr Robert C Gibler reports grants from National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases T32 Training Grant (T32DK063929), outside the submitted work. Dr Brooke L Reidy reports grants from NIH, during the conduct of the study; Frontiers in Headache Research Scholarship (travel award to attend Conference) in 2018 from American Headache Society, Travel Award to attend conference 2018 from International Society for Developmental Psychobiology, outside the submitted work. Dr. Powers reports funding to the Cincinnati Childrens Hospital Medical Center Research Foundation from the National Institutes of Health. The authors report no other conflicts of interest in this work.

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42. Hershey AD, Powers SW, Bentti AL, Degrauw TJ. Effectiveness of amitriptyline in the prophylactic management of childhood headaches. Headache. 2000;40(7):539549. doi:10.1046/j.1526-4610.2000.00085.x

43. Sakulchit T, Meckler GD, Goldman RD. Topiramate for pediatric migraine prevention. Can Fam Physician. 2017;63(7):529531.

44. Powers SW, Coffey CS, Chamberlin LA, et al. Trial of amitriptyline, topiramate, and placebo for pediatric migraine. N Engl J Med. 2017;376(2):115124. doi:10.1056/NEJMoa1610384

45. Vatzaki E, Straus S, Dogne JM, Garcia Burgos J, Girard T, Martelletti P. Latest clinical recommendations on valproate use for migraine prophylaxis in women of childbearing age: overview from European Medicines Agency and European Headache Federation. J Headache Pain. 2018;19(1):68. doi:10.1186/s10194-018-0898-3

46. El-Chammas K, Keyes J, Thompson N, Vijayakumar J, Becher D, Jackson JL. Pharmacologic treatment of pediatric headaches: a meta-analysis. JAMA Pediatr. 2013;167(3):250258. doi:10.1001/jamapediatrics.2013.508

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Workshop on promotion of physical activity in pregnancy | JMDH – Dove Medical Press

Posted: September 16, 2022 at 2:13 am

Background

The World Health Organization (WHO) recommends that women who, before pregnancy, habitually engaged in vigorous-intensity aerobic activity or who were physically active, can continue these activities during pregnancy and the postpartum period.1 The last three decades produced an increasing amount of scientific evidence on the positive effects of the prenatal physical activity on the maternal and fetal health, as well as in pregnancy outcomes, as shown by recent systematic reviews.218 Practice guidelines have become an increasingly popular tool for synthesis of clinical information.19 Clinical guidelines are commonly defined as systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances, which objectives are to enhance appropriateness of practice, improve quality of care, lead to better patient outcomes, improve cost effectiveness, help authorities to decide on the approval of drugs and devices, and identify areas of research needed.20 A profusion of guidelines has been issued over the past 6 years by different national and international obstetrics, gynecology, or sports medicine organizations, which are a trustworthy and comprehensive source of information in terms of safety and health benefits of exercise during pregnancy. Several official guidelines on physical activity during pregnancy have been updated recently.1,2129 Most of these guidelines were reviewed by other authors30 and in our textbook.31 Moreover, other organizations published these guidelines in a more accessible language to reach pregnant women.3235 Yet, the physical inactivity epidemic is considered the biggest public health problem of the 21st century.36,37

Challenges for practicing physical activity during pregnancy are numerous and include lack of knowledge about existing recommendations, unawareness of how to engage in physical activity, lack of social support, and unavailability of physical activity offers.38 Despite the above stated scientific evidence, health professionals often lack either knowledge of existing recommendations and pregnancy-related benefits or resources to adequately address the topic.39,40 Among health professionals, midwifes are ideally placed to promote physical activity during pregnancy consultations as part of a wider network of practitioners.40,41 After the assessment of potential contraindications for exercising, health-care providers should provide counseling on an active lifestyle and refer pregnant women to a qualified exercise professional (ie, exercise physiologist or prenatal exercise specialist), with a background and experience in pregnancy and/or postpartum physical activity and/or exercise.42 Interprofessional settings (including health-care providers and exercise experts) can help to reach fitness goals, tailor exercises according to abilities and - most importantly - minimize the risk of injury. Therefore, interprofessional collaboration is essential.43

When exercising during pregnancy, women need to feel safe and professionally guided to ensure proper technique, confidence, and appropriate progression of intensity and complexity.44 The exercise professional should provide proper exercise prescription and selection, along with regular feedback, positive reinforcement, and behavioral strategies to enhance adherence.45,46

The American College of Sports Medicine (ACSM)32,33 recommends that physical activity programs should be individualized for each woman based on situation, experience, and current health status. Exercise professionals can notably support aerobic training, strength training, flexibility, balance, pelvic floor muscle training, during pregnancy and postpartum.32,33,45,46 The National Health Services (NHS) guidelines34 advise pregnant women to make sure that exercise professionals are properly qualified and informed about their pregnancy status. The Sports Medicine Australia (SMA) guidelines21 advise pregnant women to ask for a medical doctors recommendation to consult exercise specialists in view of an individually prescribed exercise program including appropriate types of activities and ways to progress at a safe and steady pace. The Canadian guidelines24 and the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) guidelines26 highlight fitness professionals and exercise physiologists as target users of their evidence-based guidelines in view of maternal, fetal, and neonatal health outcomes of prenatal physical activity. The Physical Activity Guidelines for Americans23 state that physical activity specialists can encourage to attain and maintain regular physical activity by providing advice on adapted activities and ways to progress at a safe and steady pace, even for individuals with chronic conditions. These statements included in the official position documents highlight the increasing importance of the exercise professional in promoting and implementing adapted effective and safe exercise programs.

In 2016, EuropeActive published the role and standards of the Pregnancy and Postnatal Exercise Specialist, based on the European Qualification Framework.47 According to this professional educational standard, the role of the prenatal exercise specialist is to encourage exercise participation for beginners and already active women at all stages of pregnancy and during the postpartum period47 including the assessment of overall physical fitness, the development of adapted exercise programs, providing feedback on progress, adherence, and outcomes to relevant stakeholders.

The lack of information among women on the exercises during pregnancy, and lack of social support are two of the reasons hindering engagement in a prenatal exercise program.38 However, pregnancy may provide a teachable moment for positive health behaviour change,48 and a positive relationship was observed between the mothers knowledge about physical activity during pregnancy and their daily physical activity.49 Thus, promoting the guidelines and educational materials providing information about physical activity during pregnancy is expected to help pregnant women to engage in proper exercise programs.48,50

To sum up, the knowledge of health benefits is expected to lead to more favorable attitudes towards exercise during pregnancy, among pregnant women, exercise professionals and health-care providers.

With this background, a one-day workshop on promotion of physical activity in pregnancy for exercise professionals was planned and facilitated by an Associate Professor, coordinator of the masters in sciences program in Physical Activity and Health, of the Sport Sciences School of Rio Maior (ESDRM), Polytechnic Institute of Santarm, Portugal. The workshop was delivered at the ESDRM and in partnership with other higher schools of the Polytechnic Institutes of Beja and Leiria, Portugal, during 2021, to five groups of exercise professionals.

The main aim of this workshop was to motivate and prepare exercise professionals for promoting physical activity and implementing prenatal exercise programs, in their respective professional fitness center, or in remote settings, in personal training, or group exercise sessions.

The contents of the workshop were focused on six topics: 1) Role and professional development of the Pregnancy Exercise Specialist; 2) General physical and physiological adaptations during pregnancy; 3) Evidence-based benefits of physical activity during pregnancy; 4) Current guidelines for exercise during pregnancy; 5) Pre-exercise assessment and fitness testing; and 6) Exercise prescription and exercise adaptations, based on the Pregnancy and Postpartum Exercise Specialist educational standards by EuropeActive47 and on the Exercise and Physical Activity during Pregnancy and Postpartum textbook published by Springer.51,52

The following sections will mainly be structured as the report of the workshop event.

Exercise professionals attending advanced higher education programs were invited to participate in the workshop, free of charge. Participants were informed about the objectives and nature of the study, the potential benefits for future programs, that they were free to provide feedback or not, without any consequences, and that the feedback was anonymous. All participants (N = 137) were informed and agreed with the participation in the online questionnaires. Informed consent was checked upon responding to an online questionnaire. All educational materials produced by the research team were made available to the participants, free of charge. The study was conducted in accordance with the Helsinki Declaration. This study is part of the study protocol that was approved by the Ethics Committee of the Polytechnic Institute of Santarm, Portugal (approval number 9-2021-ESDRM).

The objectives of the workshop were:

The workshop was delivered in three Portuguese cities (Rio Maior, Beja and Leiria), at the facilities of the higher schools of sports and education of the respective public polytechnic institutes, and online, during 2021, to five groups of exercise professionals. Three workshops were delivered presently, and two workshops were delivered online by means of the zoom platform. The interactive teaching-learning methods were utilized in all sessions of the workshop.

The workshop was facilitated by an Associate Professor, which is the first author of this article, and it was conducted in the Portuguese language. The facilitator academic background includes a BSc in sport sciences, a MSc in exercise and health, a PhD in health and fitness, as well as professional background as exercise physiologist and fitness instructor. Each event was inaugurated by the program coordinator of each of the higher schools where it was delivered.

Between 23 and 42 persons (61% female) participated in each workshop, totaling 137 attendees including graduated exercise professionals, third year exercise science students, and master students, with 1 to 10 years of professional experience in conducting exercise classes and personal training. Only 30% of the attendees had professional experience in conducting classes for pregnant women. The academic background of all participants was a bachelors degree in exercise and sport sciences. The ages of the attendees varied from 21 to 55 years.

The contents of the workshop were inspired by the EuropeActives official document educational standard for the prenatal exercise specialist47 that the three authors of this article produced in 2016, and on the chapters developed in the textbook Exercise and Physical Activity during Pregnancy and Postpartum textbook published by Springer in 2019,51 and the second edition in 2022.52

The contents of the workshop were focused on the following six topics, delivered in 3h plus 3 hours (about one hour for each topic). The key points of each content are described as follows:

Participants were motivated for promoting physical activity, by understanding their role and the barriers and facilitators for exercising during pregnancy. Main points were: The medical and social need for Pregnancy Exercise Specialists (regarding the national laws, in this case, the Portuguese Law nr. 39/2012 of 28-08-2012); The place of the Pregnancy Exercise Specialists in the healthcare system and the cooperation of a multidisciplinary task force of health-care professionals (Obstetrician/Gynecologist, Midwife, Nutritionist, Exercise Physiologist, Exercise Psychologist, Physiotherapist); Specific evidence-based sources related to the benefits of exercise for pregnant women; National legislation, policies and guidance relating to the provision of exercise services to pregnant women; Ethical issues regarding working with pregnant women. Main references for this content: educational standard for the prenatal exercise specialist,47 chapter,43 and national Law nr. 39/2012 of 28-08-2012.

The main points were to describe the pregnancy-related symptoms and the body adaptations to pregnancy and to physical exercise, which require supervision of technique, adaptations of exercises, and safety considerations: The risk factors and prevalence of discomforts and health conditions associated with pregnancy and postpartum (eg, gestational diabetes, overweight, obesity, edema, low back pain, hypertension, pre-eclampsia, musculoskeletal disorders, diastasis recti abdominis, stress urinary and fecal incontinence and other pelvic-floor disorders, stress and anxiety, oral health, sleep disorders, headache, digestive disorders, etc.); Interactive effects of morphological, physiological and hormonal adaptations to pregnancy phases, and to exercise (eg, adaptation of cardiovascular and thermoregulation systems, metabolic changes); Musculoskeletal changes and biomechanical adaptations of posture and gait in pregnancy; Psychosocial adaptations to pregnancy and the main barriers to participation in exercise. Main references for this content: chapters.38,5356

The main points were to search the recent systematic reviews that support the positive impact of physical activity in the maternal health and fitness parameters, and how to utilize research outcomes when promoting physical activity and planning exercise programs. Participants were updated on the importance and evidence-based knowledge underlying physical activity during pregnancy, and were motivated for multidisciplinary research: The improved sense of well-being and enhanced quality of life as an effect of regular exercise during pregnancy; The acute and long-term effects of exercise in pregnant women and babies, related to all fitness and well-being parameters (eg, cardiovascular, muscular strength and endurance, flexibility, neuromotor, posture, body composition, mental health); The effect of exercise on increased energy expenditure (eg, excess post-exercise oxygen consumption, increased fat loss, preservation of lean body mass, increased metabolic rate, prevention of overweight and obesity in mother and child); The association of exercise with fertility, fetal development, birth outcomes and infant health; The preventative role of exercise in relation to any potential future cardiac health risk related to chronic disease; The preventative role of exercise in relation to gestational diabetes and diabetes mellitus type 2 (eg, lower blood glucose concentration during and after exercise, improved insulin sensitivity and decreased insulin requirement, lower glycated hemoglobin levels); The preventative role of exercise in relation to dyslipidemia (eg, decreased triglycerides, slightly decreased low-density lipoprotein, increased high-density lipoprotein); The preventative role of exercise in relation to hypertension and pre-eclampsia (eg, improvement in mild to moderate blood pressure); The preventative role of exercise in relation to the most prevalent musculoskeletal disorders (eg, low or upper back pain, pelvic floor disorders, osteoporosis and poor posture); The potentially preventative role of exercise in relation to other specific conditions of pregnancy and postpartum (eg, macrosomia, diastasis recti, pelvic girdle pain, postpartum weight retention, coronary heart disease prevention postpartum, etc.). Main references for this content: systematic review studies.218

The main points were to address and discuss the official position documents of the leading international organizations regarding physical activity and exercise during pregnancy and postpartum, published since 2018 (eg, WHO, US Department of Health and Human Services, UK Department of Health and Social Care, ACOG - American College of Obstetricians and Gynecologists, RANZCOG, CSEP - Canadian Society for Exercise Physiology, ACSM, etc.): Main guidelines for exercise during pregnancy included in the official statements and evidence-based guidelines for exercising during pregnancy and postpartum; Absolute and relative contraindications for exercising during pregnancy and postpartum; Reasons to stop exercising in pregnant and postpartum women; Sports and physical activities to avoid for pregnant and postpartum women; Safety and emergency procedures during a training session for pregnant and postpartum participants. Main references for this content: guidelines1,2129,3235 and chapter.31

The main points were to prepare participants for planning prenatal exercise programs by starting with basic assessment tools based on questionnaires of perception of health and readiness for exercising, weekly volume of physical activity, and perception of fitness and quality of life. Basic aspects and importance of fitness testing with pregnant women were addressed: Interviewing of pregnant and postpartum women and building rapport, taking into consideration the medical clearance for exercise; Preliminary screening tools, such as: the PAR-Q+ questionnaire; the new Get Active Questionnaire for Pregnancy (previously the PARMED-X for pregnancy questionnaire), to assess safety or possible contraindications to exercise; Physical activity and lifestyle assessment (eg, pedometers, accelerometers, and/or questionnaires such as the 7-day PAR - 7-day Physical Activity Recall interview and the PPAQ - Pregnancy Physical Activity Questionnaire); Safety considerations in exercise testing for pregnant women; Assessment of the pregnant womens body composition (eg, body circumferences, body fat distribution markers and other body indexes), heart rate and blood pressure, during rest and exercise; Cardiorespiratory tests (eg, Astrand, Rockport, 6 minutes walking test, Balke and Bruce tests using a treadmill or cycle ergometer); Static and dynamic tests to assess posture, functionality and overall autonomy in pregnant women. Main references for this content: chapter45 and ACSM textbook.57

The main points were to prepare participants for implementing prenatal exercise programs by following the steps of an exercise prescription plan and workout features which requires adaptations to each trimester of pregnancy. Motivational techniques for starting exercise or keeping adherence to exercise (eg, diary of behavior, active listening and communication, motivational interviewing, giving feedback on fitness tests, available educational resources, etc.); Motivational techniques to be used during exercise sessions (cuing, voice modulation, stressing the goals of exercises, feedback on exercise performance); Prescription of an exercise program (type of exercise, intensity of exercise, duration of the sessions, weekly frequency of sessions) relevant to pregnant women, their goals, medical history and exercise environment; Selection of exercises and their techniques with regard to womens well-being, functional readiness and the course of pregnancy, in particular the appearance of pregnancy discomforts (eg, back pain, stress urinary incontinence); The structure of the exercise session; The most recommended forms of exercise (eg, walking, low-impact aerobics/step exercise, water exercise, swimming, indoor cycling, strength training, pelvic-floor training, stretching); Adaptation of the so-called risky sports (eg, skiing, skating, cycling, running, etc.); Exercise equipment (eg, fitballs, step, barbells, bands); Monitoring, control and evaluation of all parameters of the exercise program (type, intensity, frequency and duration), and their adaptation to womens condition and stage of pregnancy; Portable equipment controlling the parameters of the exercise session (eg, heart rate monitor); Reports on the outcomes of an exercise program (including charts, notes and diagrams) to enhance their readability to the client and other health professionals. Main references for this content: chapters45,46 and ACSM textbook.57

Several educational materials were pointed and/or delivered, as follows:

The feedback of the participants was taken on semi-structured feedback format in order to evaluate effectiveness of the workshop, the satisfaction with the contents, as well as the venue of the event. Thus, an anonymous feedback questionnaire was provided to each participant in google forms, immediately after of the completion of the workshop. The overall response rates from the total number of attendees (in place groups = 74, online groups = 63, total attendees = 137) was 94.1% (in place groups = 67, online groups = 62, total respondents n = 129).

The questions and the descriptive analysis of the feedback answers were rated by means of a Likert scale 15 (5 = excellent, 4 = very good, 3 = good, 2 = poor, 1 = very poor), as shown in Table 1.

Table 1 Opinions of the Participants on the Quality and Effectiveness of the Workshop

Thus, most of the attendees responded that the objectives of the workshop were obtained, the contents are useful for professional practice, the venue (either school or online) is adequate, the experience of the speaker, the time management and the educational resources are excellent. The best features of the workshop were the contents, speaker, time management and educational resources. Overall, the attendees were enthusiastic about the quality of the workshop, either in person or online, and the topics addressed.

The dissatisfaction about the workshop was obtained by means of an open-ended question format. The categories included in dissatisfaction about the workshop provided by the attendees were: the short length of the workshop (17.1%), lack of practical sessions (14.7%), fewer interactions/group discussions during the workshops (14%), lack of specific fitness tests and health questionnaires for pregnancy (7%).

The various recommendations were obtained for improving future workshops, but only 27 attendees provided feedback. The aim of obtaining the recommendations was to understand the participants opinion about future workshops, particularly regarding the organization, the content and objectives of workshop and educational resources (ie, books and YouTube channel).

The answers to the open-ended question format were reported as follows:

The main recommendations and demands were the organization of more short duration workshops with round table discussion, the inclusion of practical sessions, and the separation of the contents addressing the postpartum period.

The present workshop on promotion of physical activity in pregnancy for exercise professionals was delivered to 137 exercise professionals with similar academic background (ie, graduated exercise professionals with bachelors degree in exercise sciences, third year exercise sciences students, and master in exercise sciences students) in the context of a higher education institution. The main aim of this workshop was to motivate and prepare exercise professionals for promoting physical activity and implementing prenatal exercise programs, in their respective private or public fitness centers or in other physical activity settings.

The contents of the workshop were focused on six topics based on the Pregnancy and postpartum exercise specialist educational standards by EuropeActive47 and the Exercise and Physical Activity during Pregnancy and Postpartum textbook published by Springer.51,52

The most important finding of this work is that the participants rated the content of the training and the achievement of the educational goals very highly. Therefore, the authors believe the knowledge gained could be beneficial for the participants in the future, regarding the promotion of evidence-based knowledge underlying physical activity during pregnancy, the preparation for implementing prenatal exercise programs, and the motivation for applied multidisciplinary research. However, future studies should include knowledge and skill testing, before and after the training, in order to understand how it can improve knowledge and impact practice.

Conducting such workshops is particularly important because exercise professionals play a key role in maintaining an appropriate level and quality of physical activity during pregnancy. In nine guidelines recently published by credible obstetrics, gynecology, or sports medicine institutions, experts recommend pregnant women consult with a physical activity or exercise specialist, or exercise physiologist.1,2126 This means that this professional group must be well educated and ready to cooperate both with women in the perinatal period and with obstetric care providers.42 Unfortunately, in our survey conducted a few years ago we have shown,64 that although the future exercise professionals are generally aware of the positive impact of prenatal physical activity, they lack detailed knowledge, allowing the implementation of exercise sessions with pregnant clients.

The regular organization of training workshops in this topic is also justified by the fact that in recent years there has been a dynamic increase in scientific evidence about the effectiveness of physical activity during pregnancy and after childbirth. As a result, trends in pre- and postnatal classes are also changing. One example of such a shift is high-intensity interval training (HIIT), which is gaining popularity in a wide variety of populations, including pregnant women.65 As shown by Nagpal et al,66 publicly available sources of information on how to implement HIIT in pregnancy are inconsistent and not evidence-based, which can lead to uncertainty in women and discourage them from continuing their favorite form of exercise. Another example of a significant change in the approach to exercise during pregnancy in some countries is the emphasis on the responsibility of the pregnant woman for her own health and that of the child.67 In Canada, women are encouraged to self-assess their health, pregnancy, and readiness to exercise, eg, based on the Get Active Questionnaire for Pregnancy (GAQ-P).68 Thanks to this, they do not need a doctors approval to participate in the prenatal classes. Short workshops on the new trends and tools allow exercise professionals to quickly update their knowledge and skills. The overall workshop evaluations also showed that most of the participants were satisfied with the venue and the speaker with a major recommendation as to the organization of more short duration workshops and the inclusion of practical sessions. However, few complained about the length of the workshop (ie, two sessions of 3 hours, totaling 6 hours), demanding for more workshops in near future with more group discussion and longer duration. These different opinions of participants indicate the need to properly balance the length of training and the volume of educational content. In 2021, our response to this need was the start of the work on updating the EuropeActives Pregnancy and Postpartum Exercise Specialist Standards.69,70 After careful analysis and based on a global external consultation process, in the new document we have left only those professional competences that are most needed on the labor market to work effectively and safely with pregnant and postpartum woman. This makes the knowledge and skills related to planning and conducting exercise programs for pregnant and postpartum women much more accessible to exercise professionals in less time. Although the training based on these standards should be shorter, we paid a lot of attention to practical competences.

Despite the fact that most participants were graduate exercise professionals, they demanded the organization of more workshops, either in-person or online, including practical sessions, for instances, in two days or 4 slots of 3 hours, balancing theory and practical approaches. Moreover, there is the need to upskill exercise professionals, to work as part of a wider network of professionals (eg, doctors, midwives, physiotherapists, etc.), delivering the same messages, in order to maximize the benefits to pregnant and postpartum women.71,72 These opinions were inspiration to develop an international online workshop The NEPPE The New Era of Pre- and Postnatal Exercise project, supported by the Polish National Academic Exchange Agency (NAWA).73

One-third of the participants recommended the separation of the contents addressing the exercise prescription and adaptations during the pregnancy and postpartum periods. Moreover, participants are aware that, from the perspective of exercise planning and intervention, pregnant and postpartum women are two different populations, which require different skills and expertise from exercise professionals. These opinions were inspiration to develop two separate educational modules in the new EuropeActives standards: Exercise in Pregnancy and Exercise in Postpartum. Based on our experience and observation from this workshop, the training providers should plan a separate time for the educational process aimed at achieving learning outcomes defined for these two modules. These opinions were also an inspiration to develop a new chapter on exercise prescription and selection during the early postpartum period.74

Almost 15% of the participants underlined the importance of the accreditation of this workshop as a lifelong learning (LLL) training. The issue of the recognition of LLL activities undertaken by the exercise professionals has been raised recently by EuropeActive experts.75 From the learners perspective it will contribute to professional competitiveness. Moreover, such a system will address skills shortages in the labor market and support the overall professionalization of the sector. It is also in accordance with the Council Recommendation on the European Qualifications Framework for lifelong learning.76 However, in order to enable the recognition of LLL and the accreditation of training workshops, it is necessary to develop appropriate education quality standards. One of the solutions to make the workshops accreditation process more transparent and the educational and vocational programs more comparable, is the use of educational credits. Therefore, in the updated version of the Pregnancy and Postpartum Exercise educational standards we decided to use European credit system for vocational education and training (ECVET)77 and the European Credit Transfer and Accumulation System (ECTS).78 We assume it will also facilitate the transferability of the educational modules or individual learning units between vocational education and training (VET) and higher education (HE) systems.79

In conclusion, the workshop on promotion of physical activity in pregnancy for exercise professionals was successfully organized, either in person or online, and the participants are looking forward to future workshops. Most of the workshop attendees were convinced that the participation improved their level of knowledge. Moreover, the feedback gathered during the workshop significantly contributed to updating the European educational standards for Pregnancy and Postpartum Exercise Specialists and the commencement of work on the lifelong learning offer for exercise professionals. Therefore, the updating and improvement of knowledge about the importance of physical activity in pregnancy may be translated into a more effective cooperation between exercise professionals and pregnant women in terms of planning and implementing exercise programs.

A one-day workshop on promotion of physical activity in pregnancy for exercise professionals was delivered during 2021. The main aim was to motivate and prepare exercise professionals for promoting physical activity and implementing prenatal exercise programs. The contents of the workshop were focused on six topics based on the Pregnancy and Postpartum Exercise Specialist educational standards by EuropeActive and the Exercise and Physical Activity during Pregnancy and Postpartum textbook published by Springer. The workshop was successfully organized, and the participants are looking forward for future ones.

IPDJ Instituto Portugus do Desporto e da Juventude (Portuguese Institute of Sport and Youth) for the support in the production of the educational materials. EuropeActive for the support in the production of the educational standards.

The APC of this article was funded by CCISP (Portugal) HES-SO (Switzerland) collaborative research: ACTIVE PREGNANCY - PROMOTING PHYSICAL EXERCISE AND A HEALTHY LIFESTYLE DURING PREGNANCY AND POSTPARTUM. IPSANTARM - Polytechnic Institute of Santarm, Portugal: ESDRM Sport Sciences School of Rio Maior; ESSS Health School of Santarm; ESAS Agrarian School of Santarm, and University of Applied Sciences and Arts Western Switzerland (HES-SO) - School of Health Sciences, Lausanne (HESAV).

The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.

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25. ACOG American College of Obstetricians and Gynecologists. ACOG Committee Opinion No. 804: physical activity and exercise during pregnancy and the postpartum period. Obstet Gynecol. 2020;135(4):e178e88. doi:10.1097/AOG.0000000000003772

26. RANZCOG - The Royal Australian and New Zealand College of Obstetricians and Gynaecologists. Exercise in pregnancy. RANZCOG; 2020. Available from: https://ranzcog.edu.au/womens-health/patient-information-resources/exercise-during-pregnancy. Accessed September 9, 2022.

27. UK Department of Health and Social Care. Physical activity guidelines: pregnancy and after childbirth. Infographics explaining the physical activity needed for general health benefits for women in pregnancy and after giving birth. Physical activity guidelines: pregnancy and after childbirth - GOV.UK; 2019. Available from: http://www.gov.uk. Accessed September 9, 2022.

28. Campos SB, Buglia S, Colombo CS, et al. Position statement on exercise during pregnancy and the post-partum period - 2021. Arq Bras Cardiol. 2021;117(1):160180. English, Portuguese. doi:10.36660/abc.20210408

29. Brown WJ, Hayman M, Haakstad LAH, et al. Australian guidelines for physical activity in pregnancy and postpartum. J Sci Med Sport. 2022;25. doi:10.1016/j.jsams.2022.03.008

30. Evenson KR, Mottola MF, Artal R. Review of recent physical activity guidelines during pregnancy to facilitate advice by health care providers. Obstet Gynecol Surv. 2019;74(8):481489. doi:10.1097/OGX.0000000000000693

31. Szumilewicz A, Worska A, Santos-Rocha R, Oviedo-Caro MA. Evidence-based and practice-oriented guidelines for exercising during pregnancy. In: Santos-Rocha R, editor. Exercise and Physical Activity During Pregnancy and Postpartum. Evidence-Based Guidelines. 2nd ed. Switzerland: Springer International Publishing; 2022:Ch.7.

32. EIM/ACSM. Being active during pregnancy. Exercise is Medicine/American College of Sports Medicine; 2019. Available from: https://www.exerciseismedicine.org/assets/page_documents/EIM_Rx%20for%20Health_Pregnancy.pdf. Accessed September 9, 2022.

33. ACSM - American College of Sport Medicine. ACSM information on pregnancy physical activity. American College of Sports Medicine; 2020. Available from: https://www.acsm.org/docs/default-source/files-for-resource-library/pregnancy-physical-activity.pdf?sfvrsn=12a73853_4. Accessed September 9, 2022.

34. NHS - National Health Service. Exercise in pregnancy; 2020. Available from: https://www.nhs.uk/pregnancy/keeping-well/exercise/. Accessed September 9, 2022.

35. AGDH - Australian Government. Department of Health. Guidelines for physical activity during pregnancy; 2021. Available from: https://www.health.gov.au/resources/publications/physical-activity-and-exercise-during-pregnancy-guidelines-brochure. Accessed September 9, 2022.

36. Kohl HW, Craig CL, Lambert EV, et al.; Lancet Physical Activity Series Working Group. The pandemic of physical inactivity: global action for public health. Lancet. 2012;380(9838):294305. doi:10.1016/S0140-6736(12)60898-8

37. Blair SN. Physical inactivity: the biggest public health problem of the 21st century. Br J Sports Med. 2009;43:12.

38. Atkinson L, Teychenne M. Psychological, social and behavioural changes during pregnancy: implications for physical activity and exercise. In: Santos-Rocha A, editor. Exercise and Physical Activity During Pregnancy and Postpartum. Evidence-Based Guidelines. 2nd ed. Switzerland: Springer International Publishing; 2022:Ch.2.

39. Hayman M, Reaburn P, Alley S, Cannon S, Short C. What exercise advice are women receiving from their healthcare practitioners during pregnancy? Women Birth. 2020;33(4):e357e362. doi:10.1016/j.wombi.2019.07.302

40. Okafor UB, Goon DT. Providing physical activity education and counselling during pregnancy: a qualitative study of midwives perspectives. Nig J Clin Pract. 2021;24:718728.

41. Findley A, Smith DM, Hesketh K, Keyworth C. Exploring womens experiences and decision making about physical activity during pregnancy and following birth: a qualitative study. BMC Pregnancy Childbirth. 2020;20(1):110. doi:10.1186/s12884-019-2707-7

42. Szumilewicz A. Who and how should prescribe and conduct exercise programs for pregnant women? Recommendation based on the European educational standards for pregnancy and postnatal exercise specialists. Dev Period Med. 2018;22(2):107112.

43. van Poppel M, Owe KM, Santos-Rocha R, Dias H. Physical activity, exercise and health promotion for the pregnant exerciser and the pregnant athlete. In: Santos-Rocha A, editor. Exercise and Physical Activity During Pregnancy and Postpartum. Evidence-Based Guidelines. 2nd ed. Switzerland: Springer International Publishing; 2022:Ch.1.

44. Petrov Fieril K, Fagevik Olsn M, Glantz A, Larsson M. Experiences of exercise during pregnancy among women who perform regular resistance training: a qualitative study. Phys Ther. 2014;94(8):11351143. doi:10.2522/ptj.20120432

45. Santos-Rocha R, Corrales-Gutierrez I, Szumilewicz A, Pajaujiene S. Exercise testing and prescription during pregnancy. In: Santos-Rocha R, editor. Exercise and Physical Activity During Pregnancy and Postpartum. Evidence-Based Guidelines. 2nd ed. Switzerland: Springer International Publishing; 2022:Ch.8.

46. Szumilewicz A, Santos-Rocha R. Exercise selection during pregnancy. In: Santos-Rocha R, editor. Exercise and Physical Activity During Pregnancy and Postpartum. Evidence-Based Guidelines. 2nd ed. Switzerland: Springer International Publishing; 2022:Ch.9.

47. EuropeActive. EuropeActive standards - European qualification framework level 5 - pregnancy and postnatal exercise specialist; 2016. Available from: http://www.ehfa-standards.eu/es-standards. Accessed September 9, 2022.

48. Atkinson L, Shaw RL, French DP. Is pregnancy a teachable moment for diet and physical activity behaviour change? An interpretative phenomenological analysis of the experiences of women during their first pregnancy. Br J Health Psychol. 2016;21(4):842858. doi:10.1111/bjhp.12200

49. Rabiepoor S, Rezavand S, Yas A, Ghanizadeh N. Influential factors in physical activity amongst pregnant women. Baltic J Health Phys Activity. 2019;11(2):3645. doi:10.29359/BJHPA.11.2.04

50. Tanha FD, Ghajarzadeh M, Mohseni M, Shariat M, Ranjbar M. Is ACOG guideline helpful for encouraging pregnant women to do exercise during pregnancy? Acta Med Iran. 2014;52(6):458461.

51. Santos-Rocha R. Exercise and Sporting Activity During Pregnancy. Evidence-Based Guidelines. Switzerland: Springer International Publishing; 2019.

52. Santos-Rocha R. Exercise and Physical Activity During Pregnancy and Postpartum. Evidence-Based Guidelines. 2nd ed. Switzerland: Springer International Publishing; 2022.

53. Perales M, Nagpal TS, Barakat R. Physiological changes during pregnancy. Main adaptations and discomforts and implications for physical activity and exercise. In: Santos-Rocha A, editor. Exercise and Physical Activity During Pregnancy and Postpartum. Evidence-Based Guidelines. 2nd ed. Switzerland: Springer International Publishing; 2022:Ch.3.

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Stem Cell Therapy Market worth $558 million by 2027 Exclusive Report by MarketsandMarkets – Benzinga

Posted: September 16, 2022 at 2:12 am

Chicago, Sept. 14, 2022 (GLOBE NEWSWIRE) -- Stem Cell Therapy Marketis projected to reach USD 558 million by 2027 from USD 257 million in 2022, at a CAGR of 16.8% during the forecast period, according to a new report by MarketsandMarkets. Key drivers of the stem cell therapy market include increase in stem cell research funding, expanding number of clinical trials related to stem cell therapies, and growing number of GMP-certified cell therapy production facilities. However, high costs associated with the development of stem cell therapy along with the ethical concerns related to embryonic stem cells are likely to hamper the market growth to a certain extent.

Download PDF Brochure: https://www.marketsandmarkets.com/pdfdownloadNew.asp?id=48

Browse in-depth TOC on "Stem Cell Therapy Market"155 Tables 43 Figures 166 Pages

The adipose tissue-derived MSCs segment dominates the cell source market in the stem cell therapy through 2020-2027.

The global stem cell therapy market is segmented into adipose tissue-derived MSCs (mesenchymal stem cells), bone marrow-derived MSCs, placenta/umbilical cord-derived MSCs, and other cell sources. Adipose-derived stem cell tissues can be obtained easily and also possess a variety of the regenerative properties similar to other mesenchymal stem cells/tissues. These cells are multipotent and are easy to isolate & harvest; these qualities have collectively rendered the adipose tissue-derived MSCs segment highest revenue in 2021.

In 2021, the musculoskeletal disorders ranked first in terms of revenue in the stem cell therapy market.

Based on therapeutic application, the global stem cell therapy market is segmented into musculoskeletal disorders, wounds & injuries, cardiovascular diseases, surgeries, inflammatory & autoimmune diseases, neurological disorders, and other therapeutic applications. In 2021, the musculoskeletal disorders application segment accounted for the largest share of the stem cell therapy market. Increasing market availability of stem cell-based therapeutic products across major markets and the growing patient preference for effective & early treatment strategies are driving the growth of this segment.

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The Asia Pacific region is the fastest-growing region of the stem cell therapy market in 2021.

The Asia Pacific region is estimated to grow at the highest CAGR in the stem cell therapy market during the forecast period. Japan and South Korea are the key revenue contributors of the Asia Pacific stem cell therapy market. Favorable government support for product approvals and the presence of major players in these countries are anticipated to drive the regional market growth.

The stem cell therapy market is consolidated in nature with prominent players in the stem cell therapy market include Smith+Nephew (UK), MEDIPOST Co., Ltd. (South Korea), Anterogen Co., Ltd. (South Korea), CORESTEM (South Korea), Pharmicell Co., Ltd. (South Korea), NuVasive, Inc. (US), RTI Surgical (US), AlloSource (US), JCR Pharmaceuticals Co., Ltd. (Japan), Takeda Pharmaceutical Company Limited (Japan), Holostem Terapie Avanzate Srl (Italy), Orthofix (US), Regrow Biosciences Pvt Ltd. (India), and STEMPEUTICS RESEARCH PVT LTD. (India).

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Radical lupus treatment uses CAR T-cell therapy developed for cancer – New Scientist

Posted: September 16, 2022 at 2:12 am

Five people with the autoimmune condition lupus are now in remission after receiving a version of CAR-T therapy, which was originally developed for cancer

By Clare Wilson

Illustration of a CAR-T cell

CHRISTOPH BURGSTEDT/SCIENCE PHOTO LIBRARY

A high-tech cell therapy used to treat cancer has been repurposed as a treatment for lupus, an autoimmune condition that can cause joint, kidney and heart damage.

CAR T-cell therapy has put all five people with lupus treated so far into remission. The participants have been followed up for an average of 8 months, with the first person treated 17 months ago. Thats kind of unheard of, says Chris Wincup at Kings College London, who wasnt involved in the study. This is incredibly exciting.

But it is too soon to know how long the remissions will last, says Georg Schett at the University of Erlangen-Nuremberg in Germany, who was part of the study team.

CAR T-cells were developed to treat blood cancers that arise when B cells, a type of immune cell that normally makes antibodies, start multiplying out of control.

The approach requires taking a sample of immune cells from a persons blood, genetically altering them in the lab so they attack B cells and then infusing them back into the individuals blood. It seems to put 4 out of 10 people with these kinds of cancers into remission.

Lupus, also called systemic lupus erythematosus, is caused by the immune system mistakenly reacting against peoples own DNA. This is driven by B cells making antibodies against DNA released from dying cells.

It is currently treated with medicines that suppress the immune system or, in more severe cases, with drugs that kill B cells. But the treatments cant kill all the B cells, and if the disease flares up badly, some people develop kidney failure and inflammation of their heart and brain.

Schett and his team wondered whether using CAR T-cells to hunt down all the B cells would be more effective. Within three months of receiving the treatment, all five participants were in remission, without needing to take any other medicines to control their symptoms.

The CAR T-cells were barely detectable after one month, and after three and a half months, the volunteers B cells started to return, having been produced by stem cells in bone marrow. These new B cells didnt react against the DNA.

We dont know what normally causes B cells to start reacting against DNA in people with lupus, so it is possible that some kind of trigger may start the process happening again, says Wincup.

The achievement means CAR T-cells may also be useful against other autoimmune diseases that are driven by antibodies, such as multiple sclerosis (MS), in which the immune system attacks nerves, says Schett.

Another radical treatment for MS involves rebooting the immune system by destroying it with chemotherapy. By comparison, CAR T-cells would be less invasive and more tolerable, he says.

But it is too soon to know how effective CAR T-cells will be for autoimmune conditions, says Wincup. This is a small number of patients, so we dont know if this is going to be the result for everyone.

When used in cancer, CAR T-cells are expensive to create for each person, so they may only be used for autoimmune conditions in people with severe disease when no other treatments are available, he says.

Journal reference: Nature Medicine , DOI: 10.1038/s41591-022-02017-5

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Stem Cell Therapy Market worth $558 million by 2027 Exclusive Report by MarketsandMarkets – GlobeNewswire

Posted: September 16, 2022 at 2:12 am

Chicago, Sept. 14, 2022 (GLOBE NEWSWIRE) -- Stem Cell Therapy Marketis projected to reach USD 558 million by 2027 from USD 257 million in 2022, at a CAGR of 16.8% during the forecast period, according to a new report by MarketsandMarkets. Key drivers of the stem cell therapy market include increase in stem cell research funding, expanding number of clinical trials related to stem cell therapies, and growing number of GMP-certified cell therapy production facilities. However, high costs associated with the development of stem cell therapy along with the ethical concerns related to embryonic stem cells are likely to hamper the market growth to a certain extent.

Download PDF Brochure: https://www.marketsandmarkets.com/pdfdownloadNew.asp?id=48

Browse in-depth TOC on "Stem Cell Therapy Market155 Tables 43 Figures 166 Pages

The adipose tissue-derived MSCs segment dominates the cell source market in the stem cell therapy through 2020-2027.

The global stem cell therapy market is segmented into adipose tissue-derived MSCs (mesenchymal stem cells), bone marrow-derived MSCs, placenta/umbilical cord-derived MSCs, and other cell sources. Adipose-derived stem cell tissues can be obtained easily and also possess a variety of the regenerative properties similar to other mesenchymal stem cells/tissues. These cells are multipotent and are easy to isolate & harvest; these qualities have collectively rendered the adipose tissue-derived MSCs segment highest revenue in 2021.

In 2021, the musculoskeletal disorders ranked first in terms of revenue in the stem cell therapy market.

Based on therapeutic application, the global stem cell therapy market is segmented into musculoskeletal disorders, wounds & injuries, cardiovascular diseases, surgeries, inflammatory & autoimmune diseases, neurological disorders, and other therapeutic applications. In 2021, the musculoskeletal disorders application segment accounted for the largest share of the stem cell therapy market. Increasing market availability of stem cell-based therapeutic products across major markets and the growing patient preference for effective & early treatment strategies are driving the growth of this segment.

Request Sample Pages: https://www.marketsandmarkets.com/requestsampleNew.asp?id=48

The Asia Pacific region is the fastest-growing region of the stem cell therapy market in 2021.

The Asia Pacific region is estimated to grow at the highest CAGR in the stem cell therapy market during the forecast period. Japan and South Korea are the key revenue contributors of the Asia Pacific stem cell therapy market. Favorable government support for product approvals and the presence of major players in these countries are anticipated to drive the regional market growth.

The stem cell therapy market is consolidated in nature with prominent players in the stem cell therapy market include Smith+Nephew (UK), MEDIPOST Co., Ltd. (South Korea), Anterogen Co., Ltd. (South Korea), CORESTEM (South Korea), Pharmicell Co., Ltd. (South Korea), NuVasive, Inc. (US), RTI Surgical (US), AlloSource (US), JCR Pharmaceuticals Co., Ltd. (Japan), Takeda Pharmaceutical Company Limited (Japan), Holostem Terapie Avanzate Srl (Italy), Orthofix (US), Regrow Biosciences Pvt Ltd. (India), and STEMPEUTICS RESEARCH PVT LTD. (India).

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Stem Cell Manufacturing Market by Product (Consumables, Instrument, HSCs, MSCs, iPSCs, ESCs), Application (Research, Clinical (Autologous, Allogenic), Cell & Tissue Banking), End User (Pharma & Biotech, Hospitals, Tissue Bank) - Global Forecast to 2026

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Jasper Therapeutics Announces FDA Fast Track Designation for JSP191, a novel monoclonal antibody targeting CD117, in the treatment of patients with…

Posted: September 16, 2022 at 2:12 am

Jasper Therapeutics

JSP191 is currently being evaluated in four ongoing clinical studies in allogeneic hematopoietic stem cell transplant in patients with Acute Myeloid Leukemia (AML) / Myelodysplastic Syndromes (MDS), SCID, Fanconi anemia and Sickle Cell Disease

On track to initiate a new study of JSP191 as a therapeutic in second-line therapy for patients with lower-risk MDS later this year

REDWOOD CITY, Calif., Sept. 15, 2022 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR), a biotechnology company focused on developing multiple new therapies for the field of stem and cellular medicine, today announced that JSP191, an anti-CD117 monoclonal antibody, has received fast track designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with severe combined immunodeficiency (SCID) undergoing allogeneic hematopoietic stem cell transplant. To date, JSP191 has been studied in 14 SCID patients in an ongoing multicenter clinical trial with clinical outcome data presented at academic medical conferences.

Patients born with SCID have a severely compromised immune system and need to rely on an allogeneic hematopoietic stem cell transplant to create the immune cells needed to fight infection, said Ronald Martell, President and Chief Executive Officer of Jasper Therapeutics. Unfortunately many patients are too fragile to tolerate the toxic chemotherapy doses typically used in transplant, and may suffer severe side effects or fail transplant. Along with the FDAs previous designations of Orphan and Rare Pediatric Disease for JSP191, this new Fast Track designation recognizes the potential role of JSP191 in improving clinical outcomes for these patients and will allow us to more closely work with the FDA in the upcoming months to determine a path toward a Biologics License Application (BLA) submission.

The FDAs Fast Track designation is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill unmet medical needs. The purpose is to accelerate the development of important new drugs for patients. Drugs granted Fast Track designation are eligible for more frequent meetings with the FDA to discuss the drugs development plan and ensure the collection of appropriate data needed to support approval, as well as eligibility for Accelerated Approval, Priority Review and Rolling Review if relevant criteria are met.

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About JSP191

JSP191 is a humanized monoclonal antibody that blocks stem cell factor receptor signaling leading to the clearance of hematopoietic stem and progenitor cells from the bone marrow. JSP191 is in clinical development as a stem cell transplant conditioning agent where it helps create an empty space for donor or gene-corrected transplanted stem cells to engraft. While hematopoietic cell transplantation can be curative for patients, its use is limited because standard high-dose myeloablative conditioning is associated with severe toxicities and standard low-dose conditioning has limited efficacy. To date, JSP191 has been evaluated in more than 110 healthy volunteers and patients. Four clinical trials for myelodysplastic syndromes (MDS)/ acute myeloid leukemia (AML), severe combined immunodeficiency (SCID), Fanconi anemia (FA) and Sickle Cell Disease undergoing allogeneic transplant are currently ongoing. JSP191 is also planned to enter clinical development as a second-line therapeutic in transfusion-dependent, lower-risk MDS patients to preferentially drive recovery of healthy hematopoietic stem cells in order to help restore normal hematopoiesis.

About Jasper Therapeutics

Jasper Therapeutics is a biotechnology company focused on the development of novel curative therapies based on the biology of the hematopoietic stem cell. The company is advancing two potentially groundbreaking programs. JSP191, an anti-CD117 monoclonal antibody, is in clinical development as a conditioning agent that clears hematopoietic stem cells from bone marrow in patients undergoing hematopoietic cell transplantation. It is designed to enable safer and more effective curative allogeneic hematopoietic cell transplants and gene therapies. Clinical study of JSP191 as a novel, disease-modifying, therapeutic for patients with lower risk MDS is also planned to begin in 2022. In parallel, Jasper Therapeutics is advancing its preclinical mRNA hematopoietic stem cell grafts platform, which is designed to overcome key limitations of allogeneic and autologous gene-edited stem cell grafts. Both innovative programs have the potential to transform the field and expand hematopoietic stem cell therapy cures to a greater number of patients with life-threatening cancers, genetic diseases and autoimmune diseases than is possible today. For more information, please visit us at jaspertherapeutics.com.

Forward-Looking Statements

Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as believe, may, will, estimate, continue, anticipate, intend, expect, should, would, plan, predict, potential, seem, seek, future, outlook and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding any potential benefits of the Fast Track Designation for JSP191, the potential for JSP191 to significantly improve clinical outcomes, the potential for JSP191 to address the limitations of transplant conditioning, the potential plans to initiate clinical development of JSP191 and any potential Biologics License Application for JSP191 and the expected timing for initiating clinical studies and trials. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of Jasper Therapeutics and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Jasper Therapeutics. These forward-looking statements are subject to a number of risks and uncertainties, including general economic, political and business conditions; the risk that the potential product candidates that Jasper Therapeutics develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Jasper Therapeutics product candidates; the risk that clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; the risk that Jasper Therapeutics will be unable to successfully market or gain market acceptance of its product candidates; the risk that prior study results may not be replicated; the risk that final study data may not be consistent with preliminary study data; the risk that Jasper Therapeutics product candidates may not be beneficial to patients or successfully commercialized; the risk that Jasper Therapeutics has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; the effects of competition on Jasper Therapeutics business; the risk that third parties on which Jasper Therapeutics depends for laboratory, clinical development, manufacturing and other critical services will fail to perform satisfactorily; the risk that Jasper Therapeutics business, operations, clinical development plans and timelines, and supply chain could be adversely affected by the effects of health epidemics, including the ongoing COVID-19 pandemic; the risk that Jasper Therapeutics will be unable to obtain and maintain sufficient intellectual property protection for its investigational products or will infringe the intellectual property protection of others and other risks and uncertainties indicated from time to time in Jasper Therapeutics public filings with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent Quarterly Reports on Form 10-Q. If any of these risks materialize or Jasper Therapeutics assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Jasper Therapeutics does not presently know, or that Jasper Therapeutics currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. While Jasper Therapeutics may elect to update these forward-looking statements at some point in the future, Jasper Therapeutics specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Jasper Therapeutics assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

Contacts:

John Mullaly (investors)LifeSci Advisors617-429-3548jmullaly@lifesciadvisors.com

Jeet Mahal (investors)Jasper Therapeutics650-549-1403jmahal@jaspertherapeutics.com

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T-Cell Redirection Therapy Shows Promise As Salvage Therapy in R/R Multiple Myeloma – Targeted Oncology

Posted: September 16, 2022 at 2:12 am

In a retrospective analysis of 115 patients with relapsed/refractory multiple myeloma who progressed after therapy on a bispecific antibody, researchers found that the myeloma patients can be salvaged with sequential T-cell redirection therapy.

While the depth and duration of response to bispecific antibodies do not predict how patients with multiple myeloma will respond to CAR T-cell therapy as a second-line treatment, the T-cell therapy is effective for this patient population, according to data published in Blood Advances.1

In a retrospective analysis of 115 patients with relapsed/refractory multiple myeloma (RRMM) who progressed after therapy on a bispecific antibody, phase 1 dose escalation or phase 2 clinical trial researchers found that the myeloma patients can be salvaged with sequential T-cell redirection therapy.

This T-cell therapy led to an 84% (95% CI, 60%-97%) overall response rate (ORR), but median overall survival (OS) was not reached at a 30.5-month follow-up. Moreover, the clinical benefit rate favored patients on T-cell therapy at 84% (95% CI, 60%-97%) compared with 54% (95% CI, 37%-70%) in the non-T-cell redirection arm.

Eight patients given T-cell redirection as first salvage therapy (FST) had a complete response (CR), 4 had a stringent CR (sCR), 4 had a partial response, 1 patient had stable disease, and 2 patients had partial disease. In the non-T-cell redirection arm (n = 39), there were no sCRs, 1 CR, 4 very good partial responses, 14 partial responses, 2 had minimal responses (MR), 8 had stable disease, and 10 patients had partial disease.

Of the 115 patients that failed bispecific antibody treatment, 58 patients went on to receive their FST with either T-cell redirection or a non-T- cell redirection therapy, such as chemotherapy. Nineteen patients were given T-cell redirection as their FST with 32% of these patients needing to receive a second salvage therapy (SST) due to a relapse of non-response to therapy. In comparison, 79% of patients given a non-T-cell redirected therapy needed a SST with some of these patients moving on to T-cell redirected therapy for a total of 28 patient that ultimately received T-cell redirected therapy.

Our data suggests that after treatment with a bispecific antibody, this high-risk patient population can still exhibit favorable outcomes when exposed again to T-cell redirection therapeutics such as other bispecific antibodies and CAR T-cell therapy, the researchers wrote in their published results. While conventional salvage therapy had a relatively good ORR of around 50%, it did not lead to durable responses, which translated to significantly lower [progression-free survival (PFS)] and OS.

While the researchers noted the survival results were not durable, nor significant, they did favor the initial 19 patients given T-cell redirection therapy as FST. The median PFS1 of these patients was 28.9 months (95% CI, 18.7-NE), compared to 2.6 months (95% CI, 1.9-4.1) in the non-redirection arm. Within the 19 patients, those who received a bispecific antibody as FST had a median PFS of 18.7 months (95% CI, 2.3-18.7) vs the 9 patients who got CAR-T cell therapy who did not reach their median PFS1 (95% CI, 28.9-NE), however, this finding was not statistically significant.

PSF2 was also evaluated due to the additional patients that moved to T-cell redirection therapy with the researchers observing a median PFS2 of 30.9 months (95% CI, 21.3%-37.3%) in the 28 patients given T-cell redirection as either FST or SST, compared with 5.7 months (95% CI, 3.7-7.7) for the 30 patients the didnt receive T-cell redirection therapy as either FST or SST.

OS was not reached among patients with T-cell redirection as FST nor patients on CAR T-cell therapy, but comparisons to patients in the other arm were not statistically significant. Sixty-two percent (95% CI, 44%-88%) of patients given T-cell redirection therapy had an OS at 2 years compared with to 24% (95% CI, 11%-49%) at 2 years for the remaining 30 patients.

As the clinical use and advancement of T-cell redirection therapies continue to grow, effective strategies are needed to manage outcomes for patients who relapse or are unresponsive to this initial treatment, said senior author of the study Samir Parekh, MD, director of Translational Research in Myeloma, co-leader of the Cancer Clinical Investigation program at The Tisch Cancer Institute, and a member of the Icahn Genomics Institute at the Icahn School of Medicine at Mount Sinai.2 This study shows patients relapsing after initial bispecific antibodies therapy can benefit from a second bispecific antibody or CAR T-cell therapy.

Patients in the analysis were treated on phase 1/2 trials and were a median of 60 years old at diagnosis and 67 years old at the time of their FST. Most patients in the analysis had IgG multiple myeloma with that subtype making up 50% of the T-cell redirection group. Moreover, 78% of patients overall were considered high-risk with 88% being triple-refractory and 84% progressed after being on pomalidomide (Pomalyst). Fifty-nine percent of patients had 1 prior autologous stem cell transplant.

All patients observed in the analysis were on bispecific antibody studies conducted at the Tisch Cancer Center at Mount Sinai hospital.

Future clinical trials incorporating sequential combinations of T-cell redirection therapy will build upon these findings to further develop treatment guidelines and improve long-term outcomes for multiple myeloma patients, Parekh said.

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