Overview
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.
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).
Eligibility
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
