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

NCT07419607 | Recruiting DMC

• 1 other identifier: 1305/2025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine; Headache Disorders; Pediatric Migraine

Keywords

Migraine; children; adolescents; physical activity; high intensity interval training; progressive muscle relaxation; psychoeducation; randomized controlled trial

Outcome Measures

Primary Outcomes (3)

• Mean change from baseline in migraine headache frequency

  Mean change from baseline in the number of monthly headache days, defined as any calendar day with headache.

  From enrollment to the end of treatment at 4 weeks

• Mean change from baseline in migraine intensity

  Mean change from baseline in migraine intensity measured using a 0-10 visual analogue scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain.

  From enrollment to the end of treatment at 4 weeks

• Mean change from baseline in migraine duration

  Mean change from baseline in the duration of migraine, expressed as the number of hours of pain per migraine day.

  From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (1)

• Degree of migraine-related impairment using the mean change in the PedMIDAS questionnaire´s total score

  From enrollment to the end of treatment at 4 weeks

Study Arms (2)

Participant

ACTIVE COMPARATOR

Behavioral: Weekly group training

Controls

NO INTERVENTION

Interventions

Weekly group training BEHAVIORAL

Weekly high-intensity interval training followed by progressive muscle relaxation in a group setting, plus two additional psychoeducation sessions focusing on pain management

Participant

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Department of Pediatric and Adolescent Medicine

Innsbruck, Tyrol, 6020, Austria

RECRUITING

MeSH Terms

Conditions

Migraine Disorders; Headache Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Study Officials

• Christian Lechner, MD

  Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Lechner, MD

CONTACT

+4351250423531; ch.lechner@i-med.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 19, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)