High-Intensity Interval Training and Progressive Muscle Relaxation as a Movement-Based Group Intervention for the Non-Pharmacological Prevention of Adolescent Migraine (MigraFit)
High-Intensity Interval Training and Progressive Muscle Relaxation as a Movement-Based Group Intervention for the Non-Pharmacological Prevention of Adolescent Migraine: A Controlled Pilot Study
Background: The prevalence of migraine during adolescence is 7.7%, affecting 9.7% of girls and 6.0% of boys. Despite its high prevalence, treatment options remain limited. Insufficient treatment may increase the risk of headache chronification or the development of medication-overuse headache. In Tyrol, 21.7% of children and adolescents with chronic headache exhibit medication overuse.
To improve the care of adolescents with migraine, a regularly scheduled, professionally supervised group intervention could be of considerable value. Physical exercise and relaxation techniques are already recommended in guidelines for migraine management. Although there is a substantial body of evidence regarding the effectiveness of these non-pharmacological preventive approaches in adults, findings remain heterogeneous, making it difficult to reliably estimate their true effect. Evidence in children and adolescents is still scarce.
Methods: We hypothesize that a combination of high-intensity interval training (HIIT) and progressive muscle relaxation (PMR) may provide a particularly effective non-pharmacological preventive approach. In addition, the psychosocial benefits of exercising together represent an important component of the intervention, which is therefore delivered in a group setting.
Although patients are routinely advised during medical consultations to increase their level of physical activity, implementing this recommendation in everyday life can be challenging for many adolescents. A supervised, on-site group intervention may help increase motivation and adherence.
Discussion: If the intervention results in a significant reduction in migraine attack frequency and migraine-related burden, the findings could provide a basis for securing financial support to establish the program as a long-term extension of care for adolescents with migraine. Such an intervention could sustainably reduce the burden of migraine and may therefore be of considerable relevance to real-world clinical care.
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Tyrol
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Innsbruck, Tyrol, Austria, 6020
- Department of Pediatric and Adolescent Medicine
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Diagnosed migraine as defined by ICHD-3 (International Classification of Headache Disorders, 3rd edition)
- Age: 12-18 years
- Place of residence within a 35-kilometer radius of the study site, except for children who live outside of this radius but commute close to the study site daily due to school or work attendance
Exclusion Criteria:
- Intake of continuous prophylactic medication for migraine
- Any change in migraine medication within the past 4 weeks
- Psychiatric or somatic comorbidities which could interfere with participation in a weekly group therapy that includes physical activity
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Brak interwencji: Sterownica
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Aktywny komparator: Participant
Behavioral: Weekly group training Weekly high-intensity interval training followed by progressive muscle relaxation in a group setting, plus two additional psychoeducation sessions focusing on pain management |
Weekly high-intensity interval training followed by progressive muscle relaxation in a group setting, plus two additional psychoeducation sessions focusing on pain management |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Mean change from baseline in migraine headache frequency
Ramy czasowe: From enrollment to the end of treatment at 4 weeks
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Mean change from baseline in the number of monthly headache days, defined as any calendar day with headache |
From enrollment to the end of treatment at 4 weeks
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Mean change from baseline in migraine intensity
Ramy czasowe: From enrollment to the end of treatment at 4 weeks
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Mean change from baseline in migraine intensity measured using a 0-10 visual analogue scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain |
From enrollment to the end of treatment at 4 weeks
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Mean change from baseline in migraine duration
Ramy czasowe: From enrollment to the end of treatment at 4 weeks
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Mean change from baseline in the duration of migraine, expressed as the number of hours of pain per migraine day |
From enrollment to the end of treatment at 4 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Degree of migraine-related impairment using the mean change in the PedMIDAS questionnaire´s total score
Ramy czasowe: From enrollment to the end of treatment at 4 weeks
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Migraine-related disability was assessed using the Pediatric Migraine Disability Assessment (PedMIDAS) questionnaire (total score range: 0-276). Higher scores indicate greater migraine-related disability (worse outcome). The outcome parameter was the mean change from baseline in the PedMIDAS total score. |
From enrollment to the end of treatment at 4 weeks
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Christian Lechner, MD, Department of Pediatric and Adolescent Medicine
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 1388/2024
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
This is a single-center study without the need of sharing IPD with other researchers.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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