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

February 11, 2026 updated by: Medical University Innsbruck

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Recruiting
        • Department of Pediatric and Adolescent Medicine
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Kerstin Weissenegger, MD
        • Sub-Investigator:
          • Alina Peternell, MD
        • Sub-Investigator:
          • Matthias Baumann, MD
        • Principal Investigator:
          • Christian Lechner, MD
        • Sub-Investigator:
          • Nick Milobara
        • Sub-Investigator:
          • Niklas Winkelmann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Controls
Active Comparator: Participant
Behavioral: Weekly group training
Weekly high-intensity interval training followed by progressive muscle relaxation in a group setting, plus two additional psychoeducation sessions focusing on pain management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from baseline in migraine headache frequency
Time Frame: From enrollment to the end of treatment at 4 weeks
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
Time Frame: From enrollment to the end of treatment at 4 weeks
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
Time Frame: From enrollment to the end of treatment at 4 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of migraine-related impairment using the mean change in the PedMIDAS questionnaire´s total score
Time Frame: From enrollment to the end of treatment at 4 weeks
Migraine-related disability was assessed using the Pediatric Migraine Disability Assessment (PedMIDAS) questionnaire (total score range: 0-276). Higher scores indicate greater migraine-related disability (worse outcome). The outcome parameter was the mean change from baseline in the PedMIDAS total score.
From enrollment to the end of treatment at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University Innsbruck

Investigators

  • Principal Investigator: Christian Lechner, MD, Medical University Innsbruck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1305/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a single-center study without the need of sharing IPD with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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