A Randomized Controlled Trial of an Online Hatha Yoga Program as an Add-On Therapy for Episodic High-Frequency Migraine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Migraine Frequency
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Migraine Frequency
时间窗: Baseline and Week 14
Number of migraine days per month recorded via headache diary
Migraine Pain Intensity
时间窗: Baseline and Week 14
Visual Analogue Scale (VAS/EVA 0-10), daily recorded and averaged
Functional Impact of Migraine
时间窗: Baseline and Week 14
HIT-6 and MIDAS questionnaire scores
Percentage of Completed Yoga Sessions
时间窗: 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.
Exercise Adherence Rating Scale Score
时间窗: 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.
PADEX Checklist Score
时间窗: 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.
次要结局
- 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)
研究者
Cristina García Muñoz
Assistant Professor
University of Seville