NCT07419607 MIGRAFIT: Evaluating a Group Therapy Program Combining Physical Activity, Progressive Muscle Relaxation and Psychoeducation for Adolescents With Migraine
| NCT ID | NCT07419607 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University Innsbruck |
| Condition | Migraine |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2026-03-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 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
Contact & Investigator
Christian Lechner, MD
PRINCIPAL INVESTIGATOR
Medical University Innsbruck
Frequently Asked Questions
Who can join the NCT07419607 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 17 Years, studying Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07419607 currently recruiting?
Yes, NCT07419607 is actively recruiting participants. Contact the research team at ch.lechner@i-med.ac.at for enrollment information.
Where is the NCT07419607 trial being conducted?
This trial is being conducted at Innsbruck, Austria.
Who is sponsoring the NCT07419607 clinical trial?
NCT07419607 is sponsored by Medical University Innsbruck. The principal investigator is Christian Lechner, MD at Medical University Innsbruck. The trial plans to enroll 30 participants.
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