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

Primary Purpose

Migraine Disorder

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Tai Chi training
Waiting list control group
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Disorder focused on measuring Migraine, Tai Chi, Prophylaxis, Randomized controlled trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Tai Chi training

Waiting list control group

Arm Description

The participants in this arm will receive 12-week Tai Chi training (1 hour per day, 5 days per week).

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.

Outcomes

Primary Outcome Measures

The difference in frequency of migraine attacks (the number of attacks per month)
The proportion of responders
Defined as the proportion of patients with at least a 50% reduction of the number of attacks per month

Secondary Outcome Measures

Duration of headache attack
Intensity of headache
Intensity of headache will be measured by a Visual Analogue Scale.
Stress status
The Perceived Stress Scale (PSS) will be used to measure the stress level.
Sleep quality
The Chinese version of the Pittsburgh Sleep Quality Index (PSQI) will be used to measure the sleep quality.
Sleep quantity
A 7-day daily sleep log will be used to measure the sleep quantity.
Fatigue level
The Numeric Rating Scale-fatigue (NRS-fatigue) will be used to measure fatigue level.
HRQoL
HRQoL will be measured by using the Chinese version of the SF-36.
Weight
Weight in kilograms
Height
Height in meters
Waist circumference
Waist in cm
Hip circumference
Hip circumference in cm
Percent body fat
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
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
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
Participation rate
This outcome is measured by the eligible participants at baseline assessment divided by the subjects who register the study
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
Adverse events

Full Information

First Posted
December 23, 2016
Last Updated
May 18, 2022
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT03015753
Brief Title
The Efficacy of Tai Chi Training for the Prophylaxis of Migraine in Chinese Women
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 Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorder
Keywords
Migraine, Tai Chi, Prophylaxis, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tai Chi training
Arm Type
Experimental
Arm Description
The participants in this arm will receive 12-week Tai Chi training (1 hour per day, 5 days per week).
Arm Title
Waiting list control group
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Waiting list control group
Intervention Description
At the end of the trial, participants in this arm will be offered Tai Chi training similar as Tai Chi training (TC) group.
Primary Outcome Measure Information:
Title
The difference in frequency of migraine attacks (the number of attacks per month)
Time Frame
From baseline to 12 weeks
Title
The proportion of responders
Description
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
Secondary Outcome Measure Information:
Title
Duration of headache attack
Time Frame
From the baseline to 12 weeks and 24 weeks
Title
Intensity of headache
Description
Intensity of headache will be measured by a Visual Analogue Scale.
Time Frame
From the baseline to 12 weeks and 24 weeks
Title
Stress status
Description
The Perceived Stress Scale (PSS) will be used to measure the stress level.
Time Frame
From the baseline to 12 weeks and 24 weeks
Title
Sleep quality
Description
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
Title
Sleep quantity
Description
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
Title
Fatigue level
Description
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
Title
HRQoL
Description
HRQoL will be measured by using the Chinese version of the SF-36.
Time Frame
From the baseline to 12 weeks and 24 weeks
Title
Weight
Description
Weight in kilograms
Time Frame
From the baseline to 12 weeks and 24 weeks
Title
Height
Description
Height in meters
Time Frame
From the baseline to 12 weeks and 24 weeks
Title
Waist circumference
Description
Waist in cm
Time Frame
From the baseline to 12 weeks and 24 weeks
Title
Hip circumference
Description
Hip circumference in cm
Time Frame
From baseline to 12 weeks and 24 weeks
Title
Percent body fat
Time Frame
From the baseline to 12 weeks and 24 weeks
Title
Session attendance rate
Description
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
Title
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
Description
This is to measure the maintenance of Tai Chi practice
Time Frame
12 weeks after Tai Chi training
Title
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
Description
This is to measure the maintenance of Tai Chi practice
Time Frame
12 weeks after Tai Chi training
Title
Participation rate
Description
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)
Title
Dropout rate
Description
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
Title
Adverse events
Time Frame
During intervention period (12 weeks)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yao Jie Xie, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hung Hom
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36310622
Citation
Wang 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.
Results Reference
derived

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

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