NCT07694063

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jan 2026Oct 2026

Study Start

First participant enrolled

January 27, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

July 9, 2026

Status Verified

June 1, 2026

Enrollment Period

9 months

First QC Date

June 24, 2026

Last Update Submit

July 6, 2026

Conditions

Migraine

Keywords

MigraineHatha yogaExercise therapyNon-pharmacological interventionrandomized controlled trialonline interventionheadachecomplementary therapy

Outcome Measures

Primary Outcomes (6)

  • Migraine Frequency

    Number of migraine days per month recorded via headache diary

    Baseline and Week 14

  • Migraine Pain Intensity

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

    Baseline and Week 14

  • Functional Impact of Migraine

    HIT-6 and MIDAS questionnaire scores

    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.

    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.

    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.

    Week 14

Secondary Outcomes (5)

  • Global Patient Impression of Change (PGIC)

    Week 14

  • Physical Activity Level

    Baseline and Week 14

  • Sleep Quality

    Baseline and Week 14

  • Hospital Anxiety and Depression Scale Anxiety Subscale Score

    Baseline and Week 14

  • Hospital Anxiety and Depression Scale Depression Subscale Score

    Baseline and Week 14

Study Arms (2)

Arm 1: Experimental Group Label: Hatha Yoga + Usual Pharmacological Treatment Type: Experimental

EXPERIMENTAL

* 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

Arm 2: Control Group Label: Usual Pharmacological Treatment Only Type: Active Comparator / Control

ACTIVE COMPARATOR

* 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)

Interventions

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

Also known as: CONTROL
Arm 2: Control Group Label: Usual Pharmacological Treatment Only Type: Active Comparator / Control
Hatha yogaOTHER

* 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

Arm 1: Experimental Group Label: Hatha Yoga + Usual Pharmacological Treatment Type: Experimental

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Virgen del Rocio

Seville, Sevilla, 41013, Spain

RECRUITING

Related Publications (1)

  • [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://doi.org/10.1177/0333102417738202. [3] Hawker GA, Mian S, Kendzerska T, et al. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res 2011;63. https://doi.org/10.1002/acr.20543. [4] Stewart WF, Lipton RB, Dowson AJ, et al. Development and testing of the Migraine Disability Assessment (MIDAS) Questionnaire to assess headache-related disability. Neurology 2001;56. https://doi.org/10.1212/WNL.56.suppl_1.S20. [5] Kosinski M, Bayliss MS, Bjorner JB, et al. A six-item short-form survey for measuring headache impact: The HIT-6TM. Qual Life Res 2003;12:963-74. https://doi.org/10.1023/A:1026119331193. [6] Pérez-Huerta BD, Díaz-Pulido B, Godínez-Jaimes F, et al. Cultural adaptation and psychometric validation of the exercise adherence Rating scale Mexican Spanish version (EARS-Mx). Musculoskelet Sci Pract 2025;77:103308. https://doi.org/10.1016/j.msksp.2025.103308. [7] Newman-Beinart NA, Norton S, Dowling D, et al. The development and initial psychometric evaluation of a measure assessing adherence to prescribed exercise: the Exercise Adherence Rating Scale (EARS). Physiotherapy 2017;103:180-5. https://doi.org/10.1016/j.physio.2016.11.001. [8] Lavín-Pérez AM, Del Coso J, Luque-Casado A, et al. Development and validation of the Spanish version of the PADEX checklist to promote adherence

    BACKGROUND

MeSH Terms

Conditions

Migraine DisordersHeadache

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Cristina García Muñoz, PhD

    University of Seville

    PRINCIPAL INVESTIGATOR

  • María Dolores Cortés Vega, Physiotherapist, PhD

    University of Seville

    STUDY CHAIR

Central Study Contacts

Cristina García Muñoz, PhD, PT

CONTACT

+34954551468ccriss.g@gmail.com

Sahar TaghipourAzam, PT

CONTACT

+34654238544saharttpp@gmail.com; yogamigincidencias@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 24, 2026

First Posted

July 9, 2026

Study Start

January 27, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

July 9, 2026

Record last verified: 2026-06

Locations

ES(1)