Online Hatha Yoga Program as an Add-On Therapy for Episodic High-Frequency Migraine
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Control group (receiving standard medical therapy alone), Hatha yoga.
- Кому может быть актуально
- Состояния в реестре: Migraine. Базовые параметры: 18 лет — 65 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Испания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
A Randomized Controlled Trial of an Online Hatha Yoga Program as an Add-On Therapy for Episodic High-Frequency Migraine
Обзор
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.
Подробное описание
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).
Вмешательства
- Другое 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 - Другое 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
Первичные конечные точки
- Migraine Frequency [Срок оценки: Baseline and Week 14]
- Migraine Pain Intensity [Срок оценки: Baseline and Week 14]
- Functional Impact of Migraine [Срок оценки: Baseline and Week 14]
- Percentage of Completed Yoga Sessions [Срок оценки: Weeks 1 through 12]
- Exercise Adherence Rating Scale Score [Срок оценки: Week 14]
- PADEX Checklist Score [Срок оценки: Week 14]
Вторичные конечные точки (5)
- Global Patient Impression of Change (PGIC) [Срок оценки: Week 14]
- Physical Activity Level [Срок оценки: Baseline and Week 14]
- Sleep Quality [Срок оценки: Baseline and Week 14]
- Hospital Anxiety and Depression Scale Anxiety Subscale Score [Срок оценки: Baseline and Week 14]
- Hospital Anxiety and Depression Scale Depression Subscale Score [Срок оценки: Baseline and Week 14]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Испания · 1 центр
- University Hospital Virgen del Rocio — Seville
Публикации
- [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
Идентификаторы
NCT: NCT07694063 · HVR-MIC-YOGA-2025