The Efficacy of Tai Chi Training for the Prophylaxis of Migraine in Chinese Women
A Pilot Randomized Controlled Trial to Test the Complementary Therapeutic Efficacy of Tai Chi for the Prophylaxis of Episodic Migraine in Chinese Women
1 other identifier
interventional
82
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 23, 2016
CompletedFirst Posted
Study publicly available on registry
January 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedMay 19, 2022
May 1, 2022
1.8 years
December 23, 2016
May 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (18)
Duration of headache attack
From the baseline to 12 weeks and 24 weeks
Intensity of headache
From the baseline to 12 weeks and 24 weeks
Stress status
From the baseline to 12 weeks and 24 weeks
Sleep quality
From the baseline to 12 weeks and 24 weeks
Sleep quantity
From the baseline to 12 weeks and 24 weeks
- +13 more secondary outcomes
Study Arms (2)
Tai Chi training
EXPERIMENTALThe participants in this arm will receive 12-week Tai Chi training (1 hour per day, 5 days per week).
Waiting list control group
OTHERParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hong Kong Polytechnic University
Hung Hom, Hong Kong
Related Publications (2)
Xie YJ, Tian L, Hui SS, Qin J, Gao Y, Zhang D, Ma T, Suen LKP, Wang HH, Liu ZM, Hao C, Yang L, Loke AY. Efficacy and feasibility of a 12-week Tai Chi training for the prophylaxis of episodic migraine in Hong Kong Chinese women: A randomized controlled trial. Front Public Health. 2022 Dec 13;10:1000594. doi: 10.3389/fpubh.2022.1000594. eCollection 2022.
PMID: 36582390DERIVEDWang S, Tian L, Ma T, Wong YT, Yan LJ, Gao Y, Zhang D, Hui SS, Xie YJ. Effectiveness of Tai Chi on Blood Pressure, Stress, Fatigue, and Sleep Quality among Chinese Women with Episodic Migraine: A Randomised Controlled Trial. Evid Based Complement Alternat Med. 2022 Oct 19;2022:2089139. doi: 10.1155/2022/2089139. eCollection 2022.
PMID: 36310622DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yao Jie Xie, PhD
The Hong Kong Polytechnic University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant Professor
Study Record Dates
First Submitted
December 23, 2016
First Posted
January 10, 2017
Study Start
February 1, 2016
Primary Completion
December 1, 2017
Study Completion
June 1, 2018
Last Updated
May 19, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share