Migraine DisorderNCT03015753
The Efficacy of Tai Chi Training for the Prophylaxis of Migraine in Chinese Women
A study testing Tai Chi training in people with Migraine Disorder, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Migraine Disorder
- What is being tested?
- Tai Chi training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteHong Kong
- Study dates
- Feb 2016to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Migraine Disorder
- Being tested
- Tai Chi training, Waiting list control group
- Keywords
- Migraine, Tai Chi, Prophylaxis, Randomized controlled trial
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi trainingBehavioural
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 groupOther
At the end of the trial, participants in this arm will be offered Tai Chi training similar as Tai Chi training (TC) group.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi training | Experimental | The participants in this arm will receive 12-week Tai Chi training (1 hour per day, 5 days per week). Receives: Behavioral: Tai Chi training |
| Waiting list control group | Other | 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. Receives: Other: Waiting list control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in frequency of migraine attacks (the number of attacks per month)
Measured: 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
Measured: From baseline to 12 weeks
Secondary outcomes (18)
Duration of headache attack
Measured: From the baseline to 12 weeks and 24 weeks
Intensity of headache
Intensity of headache will be measured by a Visual Analogue Scale.
Measured: From the baseline to 12 weeks and 24 weeks
Stress status
The Perceived Stress Scale (PSS) will be used to measure the stress level.
Measured: From the baseline to 12 weeks and 24 weeks
Sleep quality
The Chinese version of the Pittsburgh Sleep Quality Index (PSQI) will be used to measure the sleep quality.
Measured: From the baseline to 12 weeks and 24 weeks
Sleep quantity
A 7-day daily sleep log will be used to measure the sleep quantity.
Measured: From the baseline to 12 weeks and 24 weeks
Fatigue level
The Numeric Rating Scale-fatigue (NRS-fatigue) will be used to measure fatigue level.
Measured: From the baseline to 12 weeks and 24 weeks
HRQoL
HRQoL will be measured by using the Chinese version of the SF-36.
Measured: From the baseline to 12 weeks and 24 weeks
Weight
Weight in kilograms
Measured: From the baseline to 12 weeks and 24 weeks
Height
Height in meters
Measured: From the baseline to 12 weeks and 24 weeks
Waist circumference
Waist in cm
Measured: From the baseline to 12 weeks and 24 weeks
Hip circumference
Hip circumference in cm
Measured: From baseline to 12 weeks and 24 weeks
Percent body fat
Measured: From the baseline to 12 weeks and 24 weeks
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
Measured: 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
This is to measure the maintenance of Tai Chi practice
Measured: 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
This is to measure the maintenance of Tai Chi practice
Measured: 12 weeks after Tai Chi training
Participation rate
This outcome is measured by the eligible participants at baseline assessment divided by the subjects who register the study
Measured: At baseline assessment (4 weeks)
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
Measured: From the baseline to 12 weeks and 24 weeks
Adverse events
Measured: During intervention period (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startFeb 2016
- Primary completionDec 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Migraine DisorderStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XIE Yao Jie Grace, The Hong Kong Polytechnic University
- Investigators
- Yao Jie Xie, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015753
- Sponsor's protocol ID
- G-UA8P
- Status last verified
- May 2022
- First submitted
- 23 Dec 2016
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 36582390Wang 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.
PubMed 36310622
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03015753
- Acronym / sponsor ID
- G-UA8P
- Conditions
- Migraine Disorder
- Keywords
- Migraine, Tai Chi, Prophylaxis, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi training | Experimental | Behavioral: Tai Chi trainingThe participants in this arm will receive 12-week Tai Chi training (1 hour per day, 5 days per week). |
| Waiting list control group | Other | Other: Waiting list control groupParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai Chi trainingThe 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. | Behavioural | Tai Chi training |
| Waiting list control groupAt the end of the trial, participants in this arm will be offered Tai Chi training similar as Tai Chi training (TC) group. | Other | Waiting list control group |
Primary outcome
The difference in frequency of migraine attacks (the number of attacks per month)
Time frame: 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
18 secondary outcomes
Duration of headache attack
Time frame: From the baseline to 12 weeks and 24 weeks
Intensity of headache
Time frame: From the baseline to 12 weeks and 24 weeks
Stress status
Time frame: From the baseline to 12 weeks and 24 weeks
Sleep quality
Time frame: From the baseline to 12 weeks and 24 weeks
Sleep quantity
Time frame: From the baseline to 12 weeks and 24 weeks
Fatigue level
Time frame: From the baseline to 12 weeks and 24 weeks
HRQoL
Time frame: From the baseline to 12 weeks and 24 weeks
Weight
Time frame: From the baseline to 12 weeks and 24 weeks
Height
Time frame: From the baseline to 12 weeks and 24 weeks
Waist circumference
Time frame: From the baseline to 12 weeks and 24 weeks
Hip circumference
Time frame: From baseline to 12 weeks and 24 weeks
Percent body fat
Time frame: From the baseline to 12 weeks and 24 weeks
Session attendance rate
Time frame: 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
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
Participation rate
Time frame: At baseline assessment (4 weeks)
Dropout rate
Time frame: From the baseline to 12 weeks and 24 weeks
Adverse events
Time frame: During intervention period (12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Derived from this study: PubMed 36582390Xie 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.
- Derived from this study: PubMed 36310622Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yao Jie Xie, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi training in people with Migraine Disorder, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in frequency of migraine attacks (the number of attacks per month) (time frame: From baseline to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03015753, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.