MIGRAFIT: Evaluating a Group Therapy Program Combining Physical Activity, Progressive Muscle Relaxation and Psychoeducation for Adolescents With Migraine

Официальное название

MIGRAFIT: Evaluating a Group Therapy Program Combining Physical Activity, Progressive Muscle Relaxation and Psychoeducation for Adolescents With Migraine - Study Protocol for a Randomized Controlled Trial

Обзор

Background: Migraine is a headache disorder highly prevalent in children and adolescents. It significantly affects academic performance and quality of life. A conservative approach to pharmacological prophylaxis for pediatric patients persists in clinical practice, as potential risks must be carefully weighed against the benefits for each individual patient. Non-pharmacological interventions, including physical activity, progressive muscle relaxation (PMR) and psychoeducation have shown promising effects individually but demand a high level of patient motivation. This study protocol creates the foundation to evaluate a novel group therapy program combining high-intensity interval training (HIIT), PMR, and psychoeducation tailored for children and adolescents with migraine. Methods: This single-centre, open-label, randomized controlled trial will enrol 80 participants aged 13 to 17 years and diagnosed with migraine according to ICHD-3 criteria. Participants are randomized 1:1 into an intervention and control group. The intervention group will receive a 18-week, once-weekly 65-minute group therapy (comprising HIIT and PMR) plus two sessions of psychoeducation. The control group receives no intervention. Primary outcomes are changes in migraine frequency, duration, intensity and acute medication use, assessed through standardized headache diaries before and after the intervention. Secondary outcomes include changes in migraine-related disability (PedMIDAS questionnaire), exploratory analysis of physical activity patterns in a subgroup and a patient-centered evaluation of the intervention's feasibility and perceived effectiveness. Discussion: This trial will provide evidence on the effectiveness and feasibility of a structured, time-efficient, multimodal group therapy intervention for pediatric migraine. By combining physical and psychological strategies within a supportive group setting, the program aims to overcome key limitations of adherence and offer a non-pharmacological treatment alternative. If successful, the intervention is intended to be incorporated into routine outpatient care for pediatric migraine at the Medical University of Innsbruck.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Mean change from baseline in migraine headache frequency [Срок оценки: From enrollment to the end of treatment at 4 weeks]
• Mean change from baseline in migraine intensity [Срок оценки: From enrollment to the end of treatment at 4 weeks]
• Mean change from baseline in migraine duration [Срок оценки: From enrollment to the end of treatment at 4 weeks]

Вторичные конечные точки (1)

• Degree of migraine-related impairment using the mean change in the PedMIDAS questionnaire´s total score [Срок оценки: From enrollment to the end of treatment at 4 weeks]

Критерии участия

Критерии включения

• Diagnosed migraine as defined by ICHD-3 (International Classification of Headache Disorders, 3rd edition)
• Age: 13-17 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Австрия · 1 центр

• Department of Pediatric and Adolescent Medicine — Innsbruck

Идентификаторы

NCT: NCT07419607 · 1305/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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