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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Experimental Group Label: Hatha Yoga + Usual Pharmacological Treatment Type: Experimental | Experimental |
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| Arm 2: Control Group Label: Usual Pharmacological Treatment Only Type: Active Comparator / Control | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control group (receiving standard medical therapy alone) | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Migraine Frequency | Number of migraine days per month recorded via headache diary | Baseline and Week 14 |
| Migraine Pain Intensity | Visual Analogue Scale (VAS/EVA 0-10), daily recorded and averaged | Baseline and Week 14 |
| Functional Impact of Migraine | HIT-6 and MIDAS questionnaire scores | Baseline and Week 14 |
| Percentage of Completed Yoga Sessions | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Global Patient Impression of Change (PGIC) | 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 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cristina García Muñoz, PhD, PT | Contact | +34954551468 | ccriss.g@gmail.com | |
| Sahar TaghipourAzam, PT | Contact | +34654238544 | saharttpp@gmail.com; yogamigincidencias@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Cristina García Muñoz, PhD | University of Seville | Principal Investigator |
| María Dolores Cortés Vega, Physiotherapist, PhD | University of Seville | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Virgen del Rocio | Recruiting | Seville | Sevilla | 41013 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | [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 |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Hatha yoga | Other |
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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 | 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 | 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 | 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 |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008722 | Methods |