Migraine
Conditions
Keywords
Migraine, Hatha yoga, Exercise therapy, Non-pharmacological intervention, randomized controlled trial, online intervention, headache, complementary therapy
Brief summary
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.
Detailed description
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).
Interventions
* Continuation of usual pharmacological migraine treatment * No structured exercise/yoga program * Usual clinical follow-up * Post-study access to yoga program offered
OTHERHatha 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
Sponsors
University of Seville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Migraine Frequency | Baseline and Week 14 | Number of migraine days per month recorded via headache diary |
| Migraine Pain Intensity | Baseline and Week 14 | Visual Analogue Scale (VAS/EVA 0-10), daily recorded and averaged |
| Functional Impact of Migraine | Baseline and Week 14 | HIT-6 and MIDAS questionnaire scores |
| Percentage of Completed Yoga Sessions | 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. |
| Exercise Adherence Rating Scale Score | 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. |
| PADEX Checklist Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Patient Impression of Change (PGIC) | 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. |
| Physical Activity Level | 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. |
| Sleep Quality | 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. |
| Hospital Anxiety and Depression Scale Anxiety Subscale Score | 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. |
| Hospital Anxiety and Depression Scale Depression Subscale Score | 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. |
Countries
Spain
Contacts
CONTACTCristina García Muñoz, PhD, PT
CONTACTSahar TaghipourAzam, PT
PRINCIPAL_INVESTIGATORCristina García Muñoz, PhD
University of Seville
STUDY_CHAIRMaría Dolores Cortés Vega, Physiotherapist, PhD
University of Seville
Outcome results
None listed