Online Hatha Yoga Program as an Add-On Therapy for Episodic High-Frequency Migraine
ConditionMigraine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Seville
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Other significant neurological disorders
Severe psychiatric conditions affecting participation
Medical contraindications to moderate physical activity
Chronic migraine (≥15 headache days/month)
Trial design
Design model
Parallel
Treatments tested in this trial
Control group (receiving standard medical therapy alone)
Other intervention* Continuation of usual pharmacological migraine treatment * No structured exercise/yoga program * Usual clinical follow-up * Post-study access to yoga program offered
Hatha yoga
Other intervention* 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
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Arm 1: Experimental Group Label: Hatha Yoga + Usual Pharmacological Treatment Type: ExperimentalExperimental treatment 1 intervention
Group B: Arm 2: Control Group Label: Usual Pharmacological Treatment Only Type: Active Comparator / ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Migraine Frequency
Number of migraine days per month recorded via headache diary
Time frame
Baseline and Week 142
Migraine Pain Intensity
Visual Analogue Scale (VAS/EVA 0-10), daily recorded and averaged
Time frame
Baseline and Week 143
Functional Impact of Migraine
HIT-6 and MIDAS questionnaire scores
Time frame
Baseline and Week 144
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 12Secondary outcomes
1
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 142
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 143
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 144
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 14Sponsors and contacts
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Source ClinicalTrials.gov