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Online Hatha Yoga Program as an Add-On Therapy for Episodic High-Frequency Migraine (MIGRANE-YOGA)

6 juli 2026 uppdaterad av: Cristina García Muñoz, University of Seville

A Randomized Controlled Trial of an 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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).

Studietyp

Interventionell

Inskrivning (Beräknad)

60

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Cristina García Muñoz, PhD, PT
  • Telefonnummer: +34954551468
  • E-post: ccriss.g@gmail.com

Studera Kontakt Backup

Studieorter

  • Spanien
    • Sevilla
      • Seville, Sevilla, Spanien, 41013
        • Rekrytering
        • University Hospital Virgen del Rocio
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Cristina García Muñoz, Physiotherapist, PhD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Arm 1: Experimental Group Label: Hatha Yoga + Usual Pharmacological Treatment Type: 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
Övrig: 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
Aktiv komparator: Arm 2: Control Group Label: Usual Pharmacological Treatment Only Type: Active Comparator / Control
  • Continuation of usual pharmacological migraine treatment
  • No structured exercise/yoga program
  • Usual clinical follow-up
  • Post-study access to yoga program offered
Övrig: 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
Andra namn:
  • KONTROLLERA

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Migraine Frequency
Tidsram: Baseline and Week 14
Number of migraine days per month recorded via headache diary
Baseline and Week 14
Migraine Pain Intensity
Tidsram: Baseline and Week 14
Visual Analogue Scale (VAS/EVA 0-10), daily recorded and averaged
Baseline and Week 14
Functional Impact of Migraine
Tidsram: Baseline and Week 14
HIT-6 and MIDAS questionnaire scores
Baseline and Week 14
Percentage of Completed Yoga Sessions
Tidsram: 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.
Weeks 1 through 12
Exercise Adherence Rating Scale Score
Tidsram: 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.
Week 14
PADEX Checklist Score
Tidsram: 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.
Week 14

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Global Patient Impression of Change (PGIC)
Tidsram: 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.
Week 14
Physical Activity Level
Tidsram: 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.
Baseline and Week 14
Sleep Quality
Tidsram: 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.
Baseline and Week 14
Hospital Anxiety and Depression Scale Anxiety Subscale Score
Tidsram: 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.
Baseline and Week 14
Hospital Anxiety and Depression Scale Depression Subscale Score
Tidsram: 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.
Baseline and Week 14

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Seville

Utredare

  • Huvudutredare: Cristina García Muñoz, PhD, University of Seville
  • Studiestol: María Dolores Cortés Vega, Physiotherapist, PhD, University of Seville

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

  • [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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

27 januari 2026

Primärt slutförande (Beräknad)

30 oktober 2026

Avslutad studie (Beräknad)

30 oktober 2026

Studieregistreringsdatum

Först inskickad

24 juni 2026

Först inskickad som uppfyllde QC-kriterierna

6 juli 2026

Första postat (Faktisk)

9 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 juli 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • HVR-MIC-YOGA-2025

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