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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Tyrol
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Innsbruck, Tyrol, Austria, 6020
- Department of Pediatric and Adolescent Medicine
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Control S
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Comparador activo: 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 |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean change from baseline in migraine headache frequency
Periodo de tiempo: 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
|
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Mean change from baseline in migraine intensity
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Degree of migraine-related impairment using the mean change in the PedMIDAS questionnaire´s total score
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Christian Lechner, MD, Department of Pediatric and Adolescent Medicine
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1388/2024
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
This is a single-center study without the need of sharing IPD with other researchers.
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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