An interventional study of Control group (receiving standard medical therapy alone) and Hatha yoga in Migraine, sponsored by University of Seville. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by University of Seville · Not applicable, Interventional, and Treatment
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).
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →University of Seville is the lead sponsor of 130 studies on the registry; 39 are open to participants now.
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Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 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
Other: Hatha yoga
* Continuation of usual pharmacological migraine treatment * No structured exercise/yoga program * Usual clinical follow-up * Post-study access to yoga program offered
Other: 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
Also known as: CONTROL
* 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
Migraine Frequency
Number of migraine days per month recorded via headache diary
Time frame: Baseline and Week 14
Migraine Pain Intensity
Visual Analogue Scale (VAS/EVA 0-10), daily recorded and averaged
Time frame: Baseline and Week 14
Functional Impact of Migraine
HIT-6 and MIDAS questionnaire scores
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 14
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.
Time frame: Week 14
Physical Activity Level
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Week 14
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