Online Hatha Yoga Program as an Add-On Therapy for Episodic High-Frequency Migraine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Control group (receiving standard medical therapy alone), Hatha yoga.
- Who it may be relevant to
- Registry conditions: Migraine. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Controlled Trial of an Online Hatha Yoga Program as an Add-On Therapy for Episodic High-Frequency Migraine
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.
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
- 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 - Other 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
Primary outcome measures
- Migraine Frequency [Time frame: Baseline and Week 14]
- Migraine Pain Intensity [Time frame: Baseline and Week 14]
- Functional Impact of Migraine [Time frame: Baseline and Week 14]
- Percentage of Completed Yoga Sessions [Time frame: Weeks 1 through 12]
- Exercise Adherence Rating Scale Score [Time frame: Week 14]
- PADEX Checklist Score [Time frame: Week 14]
Secondary outcome measures (5)
- Global Patient Impression of Change (PGIC) [Time frame: Week 14]
- Physical Activity Level [Time frame: Baseline and Week 14]
- Sleep Quality [Time frame: Baseline and Week 14]
- Hospital Anxiety and Depression Scale Anxiety Subscale Score [Time frame: Baseline and Week 14]
- Hospital Anxiety and Depression Scale Depression Subscale Score [Time frame: Baseline and Week 14]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- University Hospital Virgen del Rocio — Seville
Publications
- [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://do
Identifiers
NCT: NCT07694063 · HVR-MIC-YOGA-2025