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NCT07419607

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

Recruiting now NA Last updated 19 February 2026
What this trial tests

NA trial testing Weekly group training in Migraine in 30 participants. Currently enrolling.

Timeline
1 March 2026
Primary endpoint
31 December 2026
30 June 2027

Quick facts

Lead sponsorMedical University Innsbruck
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment30
Start date1 March 2026
Primary completion31 December 2026
Estimated completion30 June 2027
Sites1 location across Austria

Drugs / interventions tested

Conditions studied

Sponsor

Medical University Innsbruck

Who can join

Adults 13 to 17, any sex, with Migraine or Headache Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Migraine

Currently open trials in the same condition.

Other Medical University Innsbruck trials

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07419607.