High-Intensity Interval Training and Progressive Muscle Relaxation as a Movement-Based Group Intervention for the Non-Pharmacological Prevention of Adolescent Migraine: A Controlled Pilot Study

NCT07850622 | Completed

• 1 other identifier: 1388/2024
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The prevalence of migraine during adolescence is 7.7%, affecting 9.7% of girls and 6.0% of boys. Despite its high prevalence, treatment options remain limited. Insufficient treatment may increase the risk of headache chronification or the development of medication-overuse headache. In Tyrol, 21.7% of children and adolescents with chronic headache exhibit medication overuse. To improve the care of adolescents with migraine, a regularly scheduled, professionally supervised group intervention could be of considerable value. Physical exercise and relaxation techniques are already recommended in guidelines for migraine management. Although there is a substantial body of evidence regarding the effectiveness of these non-pharmacological preventive approaches in adults, findings remain heterogeneous, making it difficult to reliably estimate their true effect. Evidence in children and adolescents is still scarce. Methods: We hypothesize that a combination of high-intensity interval training (HIIT) and progressive muscle relaxation (PMR) may provide a particularly effective non-pharmacological preventive approach. In addition, the psychosocial benefits of exercising together represent an important component of the intervention, which is therefore delivered in a group setting. Although patients are routinely advised during medical consultations to increase their level of physical activity, implementing this recommendation in everyday life can be challenging for many adolescents. A supervised, on-site group intervention may help increase motivation and adherence. Discussion: If the intervention results in a significant reduction in migraine attack frequency and migraine-related burden, the findings could provide a basis for securing financial support to establish the program as a long-term extension of care for adolescents with migraine. Such an intervention could sustainably reduce the burden of migraine and may therefore be of considerable relevance to real-world clinical care.

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

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: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosed migraine as defined by ICHD-3 (International Classification of Headache Disorders, 3rd edition)
• Age: 12-18 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

Location

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

  Department of Pediatric and Adolescent Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 30, 2026
• Study Start: February 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: February 1, 2026
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)