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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Hong Kong
      • Hung Hom, Hong Kong
        • The Hong Kong Polytechnic University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
From baseline to 12 weeks
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
From baseline to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of headache attack
Time Frame: From the baseline to 12 weeks and 24 weeks
From the baseline to 12 weeks and 24 weeks
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.
From the baseline to 12 weeks and 24 weeks
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.
From the baseline to 12 weeks and 24 weeks
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.
From the baseline to 12 weeks and 24 weeks
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.
From the baseline to 12 weeks and 24 weeks
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.
From the baseline to 12 weeks and 24 weeks
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.
From the baseline to 12 weeks and 24 weeks
Weight
Time Frame: From the baseline to 12 weeks and 24 weeks
Weight in kilograms
From the baseline to 12 weeks and 24 weeks
Height
Time Frame: From the baseline to 12 weeks and 24 weeks
Height in meters
From the baseline to 12 weeks and 24 weeks
Waist circumference
Time Frame: From the baseline to 12 weeks and 24 weeks
Waist in cm
From the baseline to 12 weeks and 24 weeks
Hip circumference
Time Frame: From baseline to 12 weeks and 24 weeks
Hip circumference in cm
From baseline to 12 weeks and 24 weeks
Percent body fat
Time Frame: From the baseline to 12 weeks and 24 weeks
From the baseline to 12 weeks and 24 weeks
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
From baseline to 12 weeks
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
12 weeks after Tai Chi training
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
12 weeks after Tai Chi training
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
At baseline assessment (4 weeks)
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
From the baseline to 12 weeks and 24 weeks
Adverse events
Time Frame: During intervention period (12 weeks)
During intervention period (12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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