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NCT Number: NCT07694063

Online Hatha Yoga Program as an Add-On Therapy for Episodic High-Frequency Migraine

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Virgen del Rocio

Seville, Sevilla, 41013, Spain

Location status: Recruiting

Location contact

Cristina García Muñoz, PhD

CONTACT

[email protected]

+34954551468

Cristina García Muñoz, Physiotherapist, PhD

PRINCIPAL_INVESTIGATOR

Sahar TaghipourAzam, PT

CONTACT

[email protected]

+34654238544

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control group (receiving standard medical therapy alone)

Other
  • Continuation of usual pharmacological migraine treatment
  • No structured exercise/yoga program
  • Usual clinical follow-up
  • Post-study access to yoga program offered

Other names: CONTROL

Hatha yoga

Other
  • 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 outcomes

  1. Migraine Frequency

    Time frame: Baseline and Week 14

    Number of migraine days per month recorded via headache diary

  2. Migraine Pain Intensity

    Time frame: Baseline and Week 14

    Visual Analogue Scale (VAS/EVA 0-10), daily recorded and averaged

  3. Functional Impact of Migraine

    Time frame: Baseline and Week 14

    HIT-6 and MIDAS questionnaire scores

  4. Percentage of Completed Yoga Sessions

    Time frame: 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.

  5. Exercise Adherence Rating Scale Score

    Time frame: 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.

  6. PADEX Checklist Score

    Time frame: 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 outcomes

  1. Global Patient Impression of Change (PGIC)

    Time frame: 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.

  2. Physical Activity Level

    Time frame: 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.

  3. Sleep Quality

    Time frame: 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.

  4. Hospital Anxiety and Depression Scale Anxiety Subscale Score

    Time frame: 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.

  5. Hospital Anxiety and Depression Scale Depression Subscale Score

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cristina García Muñoz, PhD, PT

CONTACT

[email protected]

+34954551468

Sahar TaghipourAzam, PT

CONTACT

[email protected]; [email protected]

+34654238544

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Registry information

Official study title

A Randomized Controlled Trial of an Online Hatha Yoga Program as an Add-On Therapy for Episodic High-Frequency Migraine

Acronym: MIGRANE-YOGA

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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