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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
82
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.
At the end of the trial, participants in this arm will be offered Tai Chi training similar as Tai Chi training (TC) group.
The Hong Kong Polytechnic University
Hung Hom, Hong Kong
The difference in frequency of migraine attacks (the number of attacks per month)
Time frame: 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
Time frame: From baseline to 12 weeks
Duration of headache attack
Time frame: From the baseline to 12 weeks and 24 weeks
Intensity of headache
Intensity of headache will be measured by a Visual Analogue Scale.
Time frame: From the baseline to 12 weeks and 24 weeks
Stress status
The Perceived Stress Scale (PSS) will be used to measure the stress level.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From the baseline to 12 weeks and 24 weeks
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HRQoL
HRQoL will be measured by using the Chinese version of the SF-36.
Time frame: From the baseline to 12 weeks and 24 weeks
Weight
Weight in kilograms
Time frame: From the baseline to 12 weeks and 24 weeks
Height
Height in meters
Time frame: From the baseline to 12 weeks and 24 weeks
Waist circumference
Waist in cm
Time frame: From the baseline to 12 weeks and 24 weeks
Hip circumference
Hip circumference in cm
Time frame: From baseline to 12 weeks and 24 weeks
Percent body fat
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From the baseline to 12 weeks and 24 weeks
Adverse events
Time frame: During intervention period (12 weeks)