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Online Hatha Yoga Program as an Add-On Therapy for Episodic High-Frequency Migraine (MIGRANE-YOGA)

6 de julio de 2026 actualizado por: Cristina García Muñoz, University of Seville

A Randomized Controlled Trial of an Online Hatha Yoga Program as an Add-On Therapy for Episodic High-Frequency Migraine

This randomized controlled trial aims to evaluate the effectiveness and feasibility of an online Hatha yoga program as an adjunct (add-on) therapy for patients with high-frequency episodic migraine. Participants will be randomly assigned to either an intervention group receiving a 12-week home-based online Hatha yoga program in addition to usual pharmacological treatment, or a control group receiving usual pharmacological care only. Outcomes include migraine frequency, pain intensity, functional disability, sleep quality, psychological symptoms, and adherence.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

This study is designed as a randomized controlled clinical trial with a parallel-group add-on design. The objective is to evaluate a non-pharmacological intervention based on an online Hatha yoga program in patients diagnosed with high-frequency episodic migraine according to ICHD criteria.

Participants will be recruited from the Headache Unit of the Virgen del Rocío University Hospital and a primary care center in Seville, Spain. After screening and informed consent, participants will be randomly assigned (1:1) to either the intervention or control group.

The intervention group will receive a 12-week home-based asynchronous online Hatha yoga program (two sessions per week, 30-45 minutes each), in addition to their usual stable pharmacological treatment. The control group will continue usual pharmacological care without structured exercise intervention.

Primary outcomes include migraine frequency, pain intensity (VAS), and functional impact (HIT-6 and MIDAS). Secondary outcomes include sleep quality (PSQI), psychological symptoms (HADS), physical activity (GPAQ), global patient impression of change (PGIC), and adherence measures (EARS and PADEX).

Assessments will be conducted at baseline (T0) and after the 14-week period (T1).

Tipo de estudio

Intervencionista

Inscripción (Estimado)

60

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Cristina García Muñoz, PhD, PT
  • Número de teléfono: +34954551468
  • Correo electrónico: ccriss.g@gmail.com

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • España
    • Sevilla
      • Seville, Sevilla, España, 41013
        • Reclutamiento
        • University Hospital Virgen del Rocio
        • Contacto:
          • Sahar TaghipourAzam, PT
          • Número de teléfono: +34654238544
          • Correo electrónico: saharttpp@gmail.com
        • Contacto:
        • Investigador principal:
          • Cristina García Muñoz, Physiotherapist, PhD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria

  • Adults aged 18-65 years
  • Diagnosis of episodic high-frequency migraine according to ICHD criteria
  • Diagnosis confirmed by a neurologist
  • At least 1-year history of migraine
  • Receiving stable pharmacological treatment for ≥3 months before enrollment
  • Willing to maintain stable medication during the study
  • Ability to understand study procedures and complete assessments
  • Signed informed consent
  • Willingness to be randomized

Exclusion Criteria

  • Other significant neurological disorders
  • Severe psychiatric conditions affecting participation
  • Medical contraindications to moderate physical activity
  • Chronic migraine (≥15 headache days/month)
  • Use of more than one preventive migraine medication
  • Lack of Spanish language comprehension
  • Lack of internet access or digital skills for online intervention

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Arm 1: Experimental Group Label: Hatha Yoga + Usual Pharmacological Treatment Type: Experimental
  • Online Hatha Yoga Program (12 weeks + 2-week follow-up)
  • 2 sessions per week
  • 30-45 minutes per session
  • Asynchronous video-based home practice
  • Standard pharmacological treatment maintained
Otro: Hatha yoga
  • Online Hatha Yoga Program (12 weeks + 2-week follow-up)
  • 2 sessions per week
  • 30-45 minutes per session
  • Asynchronous video-based home practice
  • Standard pharmacological treatment maintained
Comparador activo: Arm 2: Control Group Label: Usual Pharmacological Treatment Only Type: Active Comparator / Control
  • Continuation of usual pharmacological migraine treatment
  • No structured exercise/yoga program
  • Usual clinical follow-up
  • Post-study access to yoga program offered
Otro: Control group (receiving standard medical therapy alone)
  • Continuation of usual pharmacological migraine treatment
  • No structured exercise/yoga program
  • Usual clinical follow-up
  • Post-study access to yoga program offered
Otros nombres:
  • CONTROL

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Migraine Frequency
Periodo de tiempo: Baseline and Week 14
Number of migraine days per month recorded via headache diary
Baseline and Week 14
Migraine Pain Intensity
Periodo de tiempo: Baseline and Week 14
Visual Analogue Scale (VAS/EVA 0-10), daily recorded and averaged
Baseline and Week 14
Functional Impact of Migraine
Periodo de tiempo: Baseline and Week 14
HIT-6 and MIDAS questionnaire scores
Baseline and Week 14
Percentage of Completed Yoga Sessions
Periodo de tiempo: Weeks 1 through 12
Adherence to the yoga program assessed as the percentage of prescribed Hatha Yoga sessions completed during the 12-week intervention period. Values range from 0% to 100%, with higher percentages indicating greater adherence to the intervention.
Weeks 1 through 12
Exercise Adherence Rating Scale Score
Periodo de tiempo: Week 14
General adherence to the yoga program assessed using the Exercise Adherence Rating Scale (EARS). The EARS includes 6 items scored on a 0-4 Likert scale, with total scores ranging from 0 to 24. Higher scores indicate greater exercise adherence.
Week 14
PADEX Checklist Score
Periodo de tiempo: Week 14
Program-related adherence facilitators assessed using the Promoting Adherence to Physical Exercise (PADEX) checklist. The PADEX checklist includes 23 dichotomous Yes/No items. The score will be expressed as the percentage of affirmative responses, ranging from 0% to 100%. Higher percentages indicate a greater presence of program features supporting adherence.
Week 14

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Global Patient Impression of Change (PGIC)
Periodo de tiempo: Week 14
Patient-perceived global change assessed using the Patient Global Impression of Change scale. The scale ranges from 1 to 7, where 1 indicates "very much improved" and 7 indicates "very much worse". Higher scores indicate worse perceived global change.
Week 14
Physical Activity Level
Periodo de tiempo: Baseline and Week 14
Physical activity assessed using the World Health Organization Global Physical Activity Questionnaire. The outcome will be reported as total metabolic equivalent task minutes per week. The minimum value is 0 MET-minutes/week, with no predefined maximum value. Higher values indicate greater physical activity.
Baseline and Week 14
Sleep Quality
Periodo de tiempo: Baseline and Week 14
Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). Total scores range from 0 to 21, with higher scores indicating worse sleep quality.
Baseline and Week 14
Hospital Anxiety and Depression Scale Anxiety Subscale Score
Periodo de tiempo: Baseline and Week 14
Anxiety symptoms assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS). Scores range from 0 to 21, with higher scores indicating greater anxiety symptoms.
Baseline and Week 14
Hospital Anxiety and Depression Scale Depression Subscale Score
Periodo de tiempo: Baseline and Week 14
epression symptoms assessed using the depression subscale of the Hospital Anxiety and Depression Scale. Scores range from 0 to 21, with higher scores indicating greater depressive symptoms.
Baseline and Week 14

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Seville

Investigadores

  • Investigador principal: Cristina García Muñoz, PhD, University of Seville
  • Silla de estudio: María Dolores Cortés Vega, Physiotherapist, PhD, University of Seville

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

  • [1] Kisan R, Sujan M, Adoor M, et al. Effect of Yoga on migraine: A comprehensive study using clinical profile and cardiac autonomic functions. Int J Yoga 2014;7:126-32. https://doi.org/10.4103/0973-6131.133891. [2] Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia 2018;38:1-211. https://doi.org/10.1177/0333102417738202. [3] Hawker GA, Mian S, Kendzerska T, et al. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res 2011;63. https://doi.org/10.1002/acr.20543. [4] Stewart WF, Lipton RB, Dowson AJ, et al. Development and testing of the Migraine Disability Assessment (MIDAS) Questionnaire to assess headache-related disability. Neurology 2001;56. https://doi.org/10.1212/WNL.56.suppl_1.S20. [5] Kosinski M, Bayliss MS, Bjorner JB, et al. A six-item short-form survey for measuring headache impact: The HIT-6TM. Qual Life Res 2003;12:963-74. https://doi.org/10.1023/A:1026119331193. [6] Pérez-Huerta BD, Díaz-Pulido B, Godínez-Jaimes F, et al. Cultural adaptation and psychometric validation of the exercise adherence Rating scale Mexican Spanish version (EARS-Mx). Musculoskelet Sci Pract 2025;77:103308. https://doi.org/10.1016/j.msksp.2025.103308. [7] Newman-Beinart NA, Norton S, Dowling D, et al. The development and initial psychometric evaluation of a measure assessing adherence to prescribed exercise: the Exercise Adherence Rating Scale (EARS). Physiotherapy 2017;103:180-5. https://doi.org/10.1016/j.physio.2016.11.001. [8] Lavín-Pérez AM, Del Coso J, Luque-Casado A, et al. Development and validation of the Spanish version of the PADEX checklist to promote adherence

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

27 de enero de 2026

Finalización primaria (Estimado)

30 de octubre de 2026

Finalización del estudio (Estimado)

30 de octubre de 2026

Fechas de registro del estudio

Enviado por primera vez

24 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

6 de julio de 2026

Publicado por primera vez (Actual)

9 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

6 de julio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • HVR-MIC-YOGA-2025

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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