A Pilot Randomized Controlled Trial to Test the Complementary Therapeutic Efficacy of Tai Chi for the Prophylaxis of Episodic Migraine in Chinese Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- The proportion of responders
研究概览
简要总结
The proposed study aims to preliminarily test the effects of a 12-week Tai Chi training on the prophylaxis of episodic migraine in Chinese women, and to evaluate the feasibility, acceptability, compliance and maintenance of Tai Chi exercise among this population.
详细描述
Migraine is a disabling neurological condition, characterized by attacks of headache and associated symptoms such as photophobia, nausea, and vomiting. In Hong Kong, the overall prevalence is around 12.5%. People with repeated migraine attacks are pain and personal suffering, have impaired social and personal life, and increased financial cost of medication. More nonpharmacologic prophylactic treatments are needed to reduce the high disease burden. As a body-mind exercise, Tai Chi's potential therapeutic efficacy on the prophylaxis of migraine has caught our attention. The investigators propose to conduct a two-arm individual level randomized controlled trial. Local women diagnosed with episodic migraine between 18-65 years will be randomly assigned to one of two groups: 1) a Tai Chi training ("TC"); or 2) a waiting list control group ("control"). The control group will receive a "delayed" Tai Chi training at the end of the trial. A total of 60 participants will be randomized and the intervention period will be 12 weeks with another 12-week follow-up. Number of attacks per month (frequency of attack), intensity and duration of headache, stress, sleep quality and quantity, fatigue, HRQoL, and body composition will be measured at baseline and at 12 weeks and 24 weeks. The primary outcomes are the difference in frequency of attack from baseline to the 12 weeks after randomization, and the proportion of patients with at least a 50% reduction of the number of attacks per month. The intervention effect will be estimated by calculating the differences of outcomes from baseline to the end of the trial between the intervention and control groups using intention-to-treat analysis.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, aged 18-65 years;
- •Have a clinical diagnosis of episodic migraine according to ICHD-II criteria at least 2 months prior to enrollment;
- •At least one of the following migraine characteristics is met: nausea, vomiting, photophobia, or phonophobia;
- •Able to undertake designated level of Tai Chi exercise;
- •Live in Hong Kong, can read and speak Cantonese or Putonghua.
排除标准
- •Severe migraine attacks with disabilities that cannot perform moderate intensity physical activity;
- •Secondary headache and other neurological disease;
- •More than 5 days of non-migrainous headache per month;
- •Experience with Tai Chi practice after diagnosis of migraine;
- •Regular performance of Tai Chi or other body-mind exercises (yoga, biofeedback, medication, etc.);
- •Undergoing other alternative therapeutic treatments during recruitment period, or received other alternative therapeutic treatments in the past 12 weeks;
- •Pregnancy, lactation period, or currently using contraceptives;
- •Use of pharmacological prophylactic treatment for migraine in the past 12 weeks;
- •Drug abuse, take antipsychotic or antidepressant drugs, or take analgesics for other chronic pain more than 3 days a month in the past 12 weeks;
- •Epilepsy, or have a psychiatric disease.
结局指标
主要结局
The proportion of responders
时间窗: From baseline to 12 weeks
Defined as the proportion of patients with at least a 50% reduction of the number of attacks per month
The difference in frequency of migraine attacks (the number of attacks per month)
时间窗: From baseline to 12 weeks
次要结局
- Hip circumference(From baseline to 12 weeks and 24 weeks)
- Intensity of headache(From the baseline to 12 weeks and 24 weeks)
- Waist circumference(From the baseline to 12 weeks and 24 weeks)
- Percent body fat(From the baseline to 12 weeks and 24 weeks)
- Session attendance rate(From baseline to 12 weeks)
- Adverse events(During intervention period (12 weeks))
- Sleep quantity(From the baseline to 12 weeks and 24 weeks)
- Height(From the baseline to 12 weeks and 24 weeks)
- Duration of headache attack(From the baseline to 12 weeks and 24 weeks)
- Stress status(From the baseline to 12 weeks and 24 weeks)
- The percentage of the participants in the intervention group who keep Tai Chi exercise for 1 time per week and last 6 weeks in the 12-week follow up period(12 weeks after Tai Chi training)
- Participation rate(At baseline assessment (4 weeks))
- Sleep quality(From the baseline to 12 weeks and 24 weeks)
- Fatigue level(From the baseline to 12 weeks and 24 weeks)
- HRQoL(From the baseline to 12 weeks and 24 weeks)
- Weight(From the baseline to 12 weeks and 24 weeks)
- The number of weeks the participants in intervention group practice Tai Chi at least one time per week in the 12-week follow up period(12 weeks after Tai Chi training)
- Dropout rate(From the baseline to 12 weeks and 24 weeks)
研究者
XIE Yao Jie Grace
Research Assistant Professor
The Hong Kong Polytechnic University