Clinical Trial: The Efficacy of Tai Chi Training for the Prophylaxis of Migraine in Chinese Women
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Pilot Randomized Controlled Trial to Test the Complementary Therapeutic Efficacy of Tai Chi for the Prophylaxis of Episodic Migraine in Chinese Women
Brief Summary: 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.
Detailed Summary: 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.
Sponsor: The Hong Kong Polytechnic University
Current Primary Outcome:
- The difference in frequency of migraine attacks (the number of attacks per month) [ Time Frame: From baseline to 12 weeks ]
- The proportion of responders [ Time Frame: From baseline to 12 weeks ]Defined as the proportion of patients with at least a 50% reduction of the number of attacks per month
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Duration of headache attack [ Time Frame: From the baseline to 12 weeks and 24 weeks ]
- Intensity of headache [ Time Frame: From the baseline to 12 weeks and 24 weeks ]Intensity of headache will be measured by a Visual Analogue Scale.
- Stress status [ Time Frame: From the baseline to 12 weeks and 24 weeks ]The Perceived Stress Scale (PSS) will be used to measure the stress level.
- Sleep quality [ Time Frame: From the baseline to 12 weeks and 24 weeks ]The Chinese version of the Pittsburgh Sleep Quality Index (PSQI) will be used to measure the sleep quality.
- Sleep quantity [ Time Frame: From the baseline to 12 weeks and 24 weeks ]A 7-day daily sleep log will be used to measure the sleep quantity.
- Fatigue level [ Time Frame: From the baseline to 12 weeks and 24 weeks ]The Numeric Rating Scale-fatigue (NRS-fatigue) will be used to measure fatigue level.
- HRQoL [ Time Frame: From the baseline to 12 weeks and 24 weeks ]HRQoL will be measured by using the Chinese version of the SF-36.
- Weight [ Time Frame: From the baseline to 12 weeks and 24 weeks ]Weight in kilograms
- Height [ Time Frame: From the baseline to 12 weeks and 24 weeks ]Height in meters
- Waist circumference [ Time Frame: From the baseline to 12 weeks and 24 weeks ]Waist in cm
- Hip circumference [ Time Frame: From baseline to 12 weeks and 24 weeks ]Hip circumference in cm
- Percent body fat [ Time Frame: From the baseline to 12 weeks and 24 weeks ]
- Session attendance rate [ Time Frame: From baseline to 12 weeks ]Number of participants who truly attend the Tai Chi training session divided by the total number of participants in that training session
- 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 [ Time Frame: 12 weeks after Tai Chi training ]This is to measure the maintenance of Tai Chi practice
- 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 [ Time Frame: 12 weeks after Tai Chi training ]This is to measure the maintenance of Tai Chi practice
- Participation rate [ Time Frame: At baseline assessment (4 weeks) ]This outcome is measured by the eligible participants at baseline assessment divided by the subjects who register the study
- Dropout rate [ Time Frame: From the baseline to 12 weeks and 24 weeks ]Number of participants successfully complete the 12-week Tai Chi training and 12-week follow up divided by the number of participants at baseline
- Adverse events [ Time Frame: During intervention period (12 weeks) ]
Original Secondary Outcome:
- Duration of headache attack [ Time Frame: From the baseline to 12 weeks and 24 weeks ]
- Intensity of headache [ Time Frame: From the baseline to 12 weeks and 24 weeks ]
- Stress status [ Time Frame: From the baseline to 12 weeks and 24 weeks ]The Perceived Stress Scale (PSS) will be used to measure the stress level.
- Sleep quality [ Time Frame: From the baseline to 12 weeks and 24 weeks ]The Chinese version of the Pittsburgh Sleep Quality Index (PSQI) will be used to measure the sleep quality.
- Sleep quantity [ Time Frame: From the baseline to 12 weeks and 24 weeks ]A 7-day daily sleep log will be used to measure the sleep quantity.
- Fatigue level [ Time Frame: From the baseline to 12 weeks and 24 weeks ]The Numeric Rating Scale-fatigue (NRS-fatigue) will be used to measure fatigue level.
- HRQoL [ Time Frame: From the baseline to 12 weeks and 24 weeks ]HRQoL will be measured by using the Chinese version of the SF-36.
- Weight [ Time Frame: From the baseline to 12 weeks and 24 weeks ]Weight in kilograms
- Height [ Time Frame: From the baseline to 12 weeks and 24 weeks ]Height in meters
- Waist circumference [ Time Frame: From the baseline to 12 weeks and 24 weeks ]Waist in cm
- Hip circumference [ Time Frame: From baseline to 12 weeks and 24 weeks ]Hip circumference in cm
- Percent body fat [ Time Frame: From the baseline to 12 weeks and 24 weeks ]
- Session attendance rate [ Time Frame: From baseline to 12 weeks ]Number of participants who truly attend the Tai Chi training session divided by the total number of participants in that training session
- 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 [ Time Frame: 12 weeks after Tai Chi training ]This is to measure the maintenance of Tai Chi practice
- 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 [ Time Frame: 12 weeks after Tai Chi training ]This is to measure the maintenance of Tai Chi practice
- Participation rate [ Time Frame: At baseline assessment (4 weeks) ]This outcome is measured by the eligible participants at baseline assessment divided by the subjects who register the study
- Dropout rate [ Time Frame: From the baseline to 12 weeks and 24 weeks ]Number of participants successfully complete the 12-week Tai Chi training and 12-week follow up divided by the number of participants at baseline
- Adverse events [ Time Frame: During intervention period (12 weeks) ]
Information By: The Hong Kong Polytechnic University
Dates:
Date Received: December 23, 2016
Date Started: February 2016
Date Completion: July 2017
Last Updated: January 10, 2017
Last Verified: January 2017
