We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03015753
Recruitment Status : Recruiting
First Posted : January 10, 2017
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Migraine Disorder Behavioral: Tai Chi training Other: Waiting list control group

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Randomized Controlled Trial to Test the Complementary Therapeutic Efficacy of Tai Chi for the Prophylaxis of Episodic Migraine in Chinese Women
Study Start Date : February 2016
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Arms and Interventions

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).
Behavioral: Tai Chi training
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.
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.
Other: Waiting list control group
At the end of the trial, participants in this arm will be offered Tai Chi training similar as Tai Chi training (TC) group.


Outcome Measures

Primary Outcome Measures :
  1. The difference in frequency of migraine attacks (the number of attacks per month) [ Time Frame: From baseline to 12 weeks ]
  2. The proportion of responders [ Time Frame: From baseline to 12 weeks ]
    Defined as the proportion of patients with at least a 50% reduction of the number of attacks per month


Secondary Outcome Measures :
  1. Duration of headache attack [ Time Frame: From the baseline to 12 weeks and 24 weeks ]
  2. Intensity of headache [ Time Frame: From the baseline to 12 weeks and 24 weeks ]
    Intensity of headache will be measured by a Visual Analogue Scale.

  3. Stress status [ Time Frame: From the baseline to 12 weeks and 24 weeks ]
    The Perceived Stress Scale (PSS) will be used to measure the stress level.

  4. Sleep quality [ Time Frame: From the baseline to 12 weeks and 24 weeks ]
    The Chinese version of the Pittsburgh Sleep Quality Index (PSQI) will be used to measure the sleep quality.

  5. Sleep quantity [ Time Frame: From the baseline to 12 weeks and 24 weeks ]
    A 7-day daily sleep log will be used to measure the sleep quantity.

  6. Fatigue level [ Time Frame: From the baseline to 12 weeks and 24 weeks ]
    The Numeric Rating Scale-fatigue (NRS-fatigue) will be used to measure fatigue level.

  7. HRQoL [ Time Frame: From the baseline to 12 weeks and 24 weeks ]
    HRQoL will be measured by using the Chinese version of the SF-36.

  8. Weight [ Time Frame: From the baseline to 12 weeks and 24 weeks ]
    Weight in kilograms

  9. Height [ Time Frame: From the baseline to 12 weeks and 24 weeks ]
    Height in meters

  10. Waist circumference [ Time Frame: From the baseline to 12 weeks and 24 weeks ]
    Waist in cm

  11. Hip circumference [ Time Frame: From baseline to 12 weeks and 24 weeks ]
    Hip circumference in cm

  12. Percent body fat [ Time Frame: From the baseline to 12 weeks and 24 weeks ]
  13. Session attendance rate [ Time Frame: From baseline to 12 weeks ]
    Number of participants who truly attend the Tai Chi training session divided by the total number of participants in that training session

  14. 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 ]
    This is to measure the maintenance of Tai Chi practice

  15. 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 ]
    This is to measure the maintenance of Tai Chi practice

  16. Participation rate [ Time Frame: At baseline assessment (4 weeks) ]
    This outcome is measured by the eligible participants at baseline assessment divided by the subjects who register the study

  17. Dropout rate [ Time Frame: From the baseline to 12 weeks and 24 weeks ]
    Number of participants successfully complete the 12-week Tai Chi training and 12-week follow up divided by the number of participants at baseline

  18. Adverse events [ Time Frame: During intervention period (12 weeks) ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015753


Contacts
Contact: Yao Jie Xie, PhD (852) 3400 3798 grace.yj.xie@polyu.edu.hk

Locations
Hong Kong
The Hong Kong Polytechnic University Recruiting
Hung Hom, Hong Kong
Contact: Yao Jie Xie, PhD    (852) 3400 3798    grace.yj.xie@polyu.edu.hk   
Principal Investigator: Yao Jie Xie, PhD         
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
Principal Investigator: Yao Jie Xie, PhD The Hong Kong Polytechnic University
More Information

Responsible Party: XIE Yao Jie Grace, Research Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT03015753     History of Changes
Other Study ID Numbers: G-UA8P
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by XIE Yao Jie Grace, The Hong Kong Polytechnic University:
Migraine
Tai Chi
Prophylaxis
Randomized controlled trial

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases