The Efficacy of Tai Chi Training for the Prophylaxis of Migraine in Chinese Women

Study Overview
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Brief Summary
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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 Description
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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.

Official Title
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A Pilot Randomized Controlled Trial to Test the Complementary Therapeutic Efficacy of Tai Chi for the Prophylaxis of Episodic Migraine in Chinese Women

Conditions
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Migraine Disorder

Intervention / Treatment
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* Behavioral: Tai Chi training
* Other: Waiting list control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tai Chi training<br>The participants in this arm will receive 12-week Tai Chi training (1 hour per day, 5 days per week). | Behavioral: Tai Chi training<br>* The 12-week Tai Chi training will be prescribed with three 1-hour instructor-led sessions and two 1-hour self-practice sessions per week. A modified 32-short form Yang-style Tai Chi Chuan will be adopted. The instructor-led sessions will be operated by qualified Tai Chi masters. The training activity will be delivered in group. The group size is 15 to 18 persons.<br>|
| Other: Waiting list control group<br>Participants in this arm will be asked to maintain their usual lifestyles and exercises for 12 weeks. At the end of the trial , the participants will be offered Tai Chi training similar as Tai Chi group. | Other: Waiting list control group<br>* At the end of the trial, participants in this arm will be offered Tai Chi training similar as Tai Chi training (TC) group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in frequency of migraine attacks (the number of attacks per month) |  | From baseline to 12 weeks | 
| The proportion of responders | Defined as the proportion of patients with at least a 50% reduction of the number of attacks per month | From baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of headache attack |  | From the baseline to 12 weeks and 24 weeks | 
| Intensity of headache | Intensity of headache will be measured by a Visual Analogue Scale. | From the baseline to 12 weeks and 24 weeks | 
| Stress status | The Perceived Stress Scale (PSS) will be used to measure the stress level. | From the baseline to 12 weeks and 24 weeks | 
| Sleep quality | The Chinese version of the Pittsburgh Sleep Quality Index (PSQI) will be used to measure the sleep quality. | From the baseline to 12 weeks and 24 weeks | 
| Sleep quantity | A 7-day daily sleep log will be used to measure the sleep quantity. | From the baseline to 12 weeks and 24 weeks | 
| Fatigue level | The Numeric Rating Scale-fatigue (NRS-fatigue) will be used to measure fatigue level. | From the baseline to 12 weeks and 24 weeks | 
| HRQoL | HRQoL will be measured by using the Chinese version of the SF-36. | From the baseline to 12 weeks and 24 weeks | 
| Weight | Weight in kilograms | From the baseline to 12 weeks and 24 weeks | 
| Height | Height in meters | From the baseline to 12 weeks and 24 weeks | 
| Waist circumference | Waist in cm | From the baseline to 12 weeks and 24 weeks | 
| Hip circumference | Hip circumference in cm | From baseline to 12 weeks and 24 weeks | 
| Percent body fat |  | From the baseline to 12 weeks and 24 weeks | 
| Session attendance rate | Number of participants who truly attend the Tai Chi training session divided by the total number of participants in that training session | From baseline to 12 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 | This is to measure the maintenance of Tai Chi practice | 12 weeks after Tai Chi training | 
| 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 | This is to measure the maintenance of Tai Chi practice | 12 weeks after Tai Chi training | 
| Participation rate | This outcome is measured by the eligible participants at baseline assessment divided by the subjects who register the study | At baseline assessment (4 weeks) | 
| Dropout rate | Number of participants successfully complete the 12-week Tai Chi training and 12-week follow up divided by the number of participants at baseline | From the baseline to 12 weeks and 24 weeks | 
| Adverse events |  | During intervention period (12 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, Tai Chi, Prophylaxis, Randomized controlled trial