Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
The difference in frequency of migraine attacks (the number of attacks per month) |
|
From baseline to 12 weeks |
|
Primary |
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 |
Duration of headache attack |
|
From the baseline to 12 weeks and 24 weeks |
|
Secondary |
Intensity of headache |
Intensity of headache will be measured by a Visual Analogue Scale. |
From the baseline to 12 weeks and 24 weeks |
|
Secondary |
Stress status |
The Perceived Stress Scale (PSS) will be used to measure the stress level. |
From the baseline to 12 weeks and 24 weeks |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
HRQoL |
HRQoL will be measured by using the Chinese version of the SF-36. |
From the baseline to 12 weeks and 24 weeks |
|
Secondary |
Weight |
Weight in kilograms |
From the baseline to 12 weeks and 24 weeks |
|
Secondary |
Height |
Height in meters |
From the baseline to 12 weeks and 24 weeks |
|
Secondary |
Waist circumference |
Waist in cm |
From the baseline to 12 weeks and 24 weeks |
|
Secondary |
Hip circumference |
Hip circumference in cm |
From baseline to 12 weeks and 24 weeks |
|
Secondary |
Percent body fat |
|
From the baseline to 12 weeks and 24 weeks |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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) |
|
Secondary |
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 |
|
Secondary |
Adverse events |
|
During intervention period (12 weeks) |
|