- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03015753
The Efficacy of Tai Chi Training for the Prophylaxis of Migraine in Chinese Women
May 18, 2022 updated by: XIE Yao Jie Grace, The Hong Kong Polytechnic University
A Pilot Randomized Controlled Trial to Test the Complementary Therapeutic Efficacy of Tai Chi for the Prophylaxis of Episodic Migraine in Chinese Women
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
82
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hung Hom, Hong Kong
- The Hong Kong Polytechnic University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tai Chi training
The participants in this arm will receive 12-week Tai Chi training (1 hour per day, 5 days per week).
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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.
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Other: Waiting list control group
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.
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At the end of the trial, participants in this arm will be offered Tai Chi training similar as Tai Chi training (TC) group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The difference in frequency of migraine attacks (the number of attacks per month)
Time Frame: From baseline to 12 weeks
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From baseline to 12 weeks
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The proportion of responders
Time Frame: From baseline to 12 weeks
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Defined as the proportion of patients with at least a 50% reduction of the number of attacks per month
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From baseline to 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of headache attack
Time Frame: From the baseline to 12 weeks and 24 weeks
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From the baseline to 12 weeks and 24 weeks
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Intensity of headache
Time Frame: From the baseline to 12 weeks and 24 weeks
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Intensity of headache will be measured by a Visual Analogue Scale.
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From the baseline to 12 weeks and 24 weeks
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Stress status
Time Frame: From the baseline to 12 weeks and 24 weeks
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The Perceived Stress Scale (PSS) will be used to measure the stress level.
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From the baseline to 12 weeks and 24 weeks
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Sleep quality
Time Frame: From the baseline to 12 weeks and 24 weeks
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The Chinese version of the Pittsburgh Sleep Quality Index (PSQI) will be used to measure the sleep quality.
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From the baseline to 12 weeks and 24 weeks
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Sleep quantity
Time Frame: From the baseline to 12 weeks and 24 weeks
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A 7-day daily sleep log will be used to measure the sleep quantity.
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From the baseline to 12 weeks and 24 weeks
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Fatigue level
Time Frame: From the baseline to 12 weeks and 24 weeks
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The Numeric Rating Scale-fatigue (NRS-fatigue) will be used to measure fatigue level.
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From the baseline to 12 weeks and 24 weeks
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HRQoL
Time Frame: From the baseline to 12 weeks and 24 weeks
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HRQoL will be measured by using the Chinese version of the SF-36.
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From the baseline to 12 weeks and 24 weeks
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Weight
Time Frame: From the baseline to 12 weeks and 24 weeks
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Weight in kilograms
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From the baseline to 12 weeks and 24 weeks
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Height
Time Frame: From the baseline to 12 weeks and 24 weeks
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Height in meters
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From the baseline to 12 weeks and 24 weeks
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Waist circumference
Time Frame: From the baseline to 12 weeks and 24 weeks
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Waist in cm
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From the baseline to 12 weeks and 24 weeks
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Hip circumference
Time Frame: From baseline to 12 weeks and 24 weeks
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Hip circumference in cm
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From baseline to 12 weeks and 24 weeks
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Percent body fat
Time Frame: From the baseline to 12 weeks and 24 weeks
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From the baseline to 12 weeks and 24 weeks
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Session attendance rate
Time Frame: From baseline to 12 weeks
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Number of participants who truly attend the Tai Chi training session divided by the total number of participants in that training session
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From baseline to 12 weeks
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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
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This is to measure the maintenance of Tai Chi practice
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12 weeks after Tai Chi training
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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
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This is to measure the maintenance of Tai Chi practice
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12 weeks after Tai Chi training
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Participation rate
Time Frame: At baseline assessment (4 weeks)
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This outcome is measured by the eligible participants at baseline assessment divided by the subjects who register the study
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At baseline assessment (4 weeks)
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Dropout rate
Time Frame: From the baseline to 12 weeks and 24 weeks
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Number of participants successfully complete the 12-week Tai Chi training and 12-week follow up divided by the number of participants at baseline
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From the baseline to 12 weeks and 24 weeks
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Adverse events
Time Frame: During intervention period (12 weeks)
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During intervention period (12 weeks)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2016
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
June 1, 2018
Study Registration Dates
First Submitted
December 23, 2016
First Submitted That Met QC Criteria
January 9, 2017
First Posted (Estimate)
January 10, 2017
Study Record Updates
Last Update Posted (Actual)
May 19, 2022
Last Update Submitted That Met QC Criteria
May 18, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- G-UA8P
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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