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NCT07419607
MIGRAFIT: Evaluating a Group Therapy Program Combining Physical Activity, Progressive Muscle Relaxation and Psychoeducation for Adolescents With Migraine
NA trial testing Weekly group training in Migraine in 30 participants. Currently enrolling.
31 December 2026
Quick facts
| Lead sponsor | Medical University Innsbruck |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 30 |
| Start date | 1 March 2026 |
| Primary completion | 31 December 2026 |
| Estimated completion | 30 June 2027 |
| Sites | 1 location across Austria |
Drugs / interventions tested
- Weekly group training
Conditions studied
- Migraine — all drugs for Migraine →
- Headache Disorders — all drugs for Headache Disorders →
- Pediatric Migraine — all drugs for Pediatric Migraine →
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.
Verify or expand the search:
- PubMed search for NCT07419607
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07419607 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medical University Innsbruck
- Last refreshed: 19 February 2026
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.