High-Intensity Interval Training and Progressive Muscle Relaxation as a Movement-Based Group Intervention for the Non-Pharmacological Prevention of Adolescent Migraine (MigraFit)
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
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Tyrol
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Innsbruck, Tyrol, Austria, 6020
- Department of Pediatric and Adolescent Medicine
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 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
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Nessun intervento: Controlli
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Comparatore attivo: 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 |
Weekly high-intensity interval training followed by progressive muscle relaxation in a group setting, plus two additional psychoeducation sessions focusing on pain management |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Mean change from baseline in migraine headache frequency
Lasso di tempo: From enrollment to the end of treatment at 4 weeks
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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
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Mean change from baseline in migraine intensity
Lasso di tempo: 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
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Mean change from baseline in migraine duration
Lasso di tempo: 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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Degree of migraine-related impairment using the mean change in the PedMIDAS questionnaire´s total score
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Christian Lechner, MD, Department of Pediatric and Adolescent Medicine
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 1388/2024
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
This is a single-center study without the need of sharing IPD with other researchers.
Informazioni su farmaci e dispositivi, documenti di studio
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