Group program of exercise, progressive muscle relaxation, and education for teens with migraine
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
This study will try a weekly group program combining high-intensity interval exercise, progressive muscle relaxation, and psychoeducation for 13–17-year-olds with migraine to see if it reduces headaches and improves daily life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 13 Years to 17 Years |
| Sex | All |
| Sponsor | Medical University Innsbruck Academic / other |
| Locations | 1 site (Innsbruck, Tyrol) |
| Trial ID | NCT07419607 on ClinicalTrials.gov |
What this trial studies
This single-center, open-label randomized trial will enroll 80 adolescents (ages 13–17) with migraine diagnosed by ICHD-3 criteria and randomize them 1:1 to the group program or a control arm. The intervention consists of weekly group training sessions that combine high-intensity interval training (HIIT), progressive muscle relaxation (PMR), and migraine-focused psychoeducation. Participants must live within approximately 35 km of the study site (with an exception for daily commuters) and must not be on continuous prophylactic migraine medication or have comorbidities that preclude participation. Outcomes will include headache frequency, symptom burden, and quality of life measures over the study period.
Who should consider this trial
Good fit: Teens aged 13–17 with a confirmed ICHD-3 migraine diagnosis who can attend weekly group sessions and live within about 35 kilometers of Innsbruck (or commute daily) are ideal candidates.
Not a fit: Patients taking continuous prophylactic migraine medication, those who changed migraine medication in the past four weeks, or those with psychiatric or physical conditions that prevent regular participation in group exercise are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, the program could lower migraine frequency and severity and improve school performance and quality of life without adding preventive medications.
How similar studies have performed: Individual components like exercise, progressive muscle relaxation, and psychoeducation have shown promising but limited benefits in youth, so combining them in a group program is a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Innsbruck, Tyrol
- Department of Pediatric and Adolescent Medicine — Innsbruck, Tyrol, Austria (Recruiting)
Study contacts
- Principal investigator: Christian Lechner, MD — Medical University Innsbruck
- Study coordinator: Christian Lechner, MD
- Email: ch.lechner@i-med.ac.at
- Phone: +4351250423531
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.