<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03015753</url>
  </required_header>
  <id_info>
    <org_study_id>G-UA8P</org_study_id>
    <nct_id>NCT03015753</nct_id>
  </id_info>
  <brief_title>The Efficacy of Tai Chi Training for the Prophylaxis of Migraine in Chinese Women</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hong Kong Polytechnic University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study aims to preliminarily test the effects of a 12-week Tai Chi training on&#xD;
      the prophylaxis of episodic migraine in Chinese women, and to evaluate the feasibility,&#xD;
      acceptability, compliance and maintenance of Tai Chi exercise among this population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Migraine is a disabling neurological condition, characterized by attacks of headache and&#xD;
      associated symptoms such as photophobia, nausea, and vomiting. In Hong Kong, the overall&#xD;
      prevalence is around 12.5%. People with repeated migraine attacks are pain and personal&#xD;
      suffering, have impaired social and personal life, and increased financial cost of&#xD;
      medication. More nonpharmacologic prophylactic treatments are needed to reduce the high&#xD;
      disease burden. As a body-mind exercise, Tai Chi's potential therapeutic efficacy on the&#xD;
      prophylaxis of migraine has caught our attention. The investigators propose to conduct a&#xD;
      two-arm individual level randomized controlled trial. Local women diagnosed with episodic&#xD;
      migraine between 18-65 years will be randomly assigned to one of two groups: 1) a Tai Chi&#xD;
      training (&quot;TC&quot;); or 2) a waiting list control group (&quot;control&quot;). The control group will&#xD;
      receive a &quot;delayed&quot; Tai Chi training at the end of the trial. A total of 60 participants will&#xD;
      be randomized and the intervention period will be 12 weeks with another 12-week follow-up.&#xD;
      Number of attacks per month (frequency of attack), intensity and duration of headache,&#xD;
      stress, sleep quality and quantity, fatigue, HRQoL, and body composition will be measured at&#xD;
      baseline and at 12 weeks and 24 weeks. The primary outcomes are the difference in frequency&#xD;
      of attack from baseline to the 12 weeks after randomization, and the proportion of patients&#xD;
      with at least a 50% reduction of the number of attacks per month. The intervention effect&#xD;
      will be estimated by calculating the differences of outcomes from baseline to the end of the&#xD;
      trial between the intervention and control groups using intention-to-treat analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2016</start_date>
  <completion_date type="Actual">June 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The difference in frequency of migraine attacks (the number of attacks per month)</measure>
    <time_frame>From baseline to 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The proportion of responders</measure>
    <time_frame>From baseline to 12 weeks</time_frame>
    <description>Defined as the proportion of patients with at least a 50% reduction of the number of attacks per month</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of headache attack</measure>
    <time_frame>From the baseline to 12 weeks and 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of headache</measure>
    <time_frame>From the baseline to 12 weeks and 24 weeks</time_frame>
    <description>Intensity of headache will be measured by a Visual Analogue Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress status</measure>
    <time_frame>From the baseline to 12 weeks and 24 weeks</time_frame>
    <description>The Perceived Stress Scale (PSS) will be used to measure the stress level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality</measure>
    <time_frame>From the baseline to 12 weeks and 24 weeks</time_frame>
    <description>The Chinese version of the Pittsburgh Sleep Quality Index (PSQI) will be used to measure the sleep quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quantity</measure>
    <time_frame>From the baseline to 12 weeks and 24 weeks</time_frame>
    <description>A 7-day daily sleep log will be used to measure the sleep quantity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue level</measure>
    <time_frame>From the baseline to 12 weeks and 24 weeks</time_frame>
    <description>The Numeric Rating Scale-fatigue (NRS-fatigue) will be used to measure fatigue level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HRQoL</measure>
    <time_frame>From the baseline to 12 weeks and 24 weeks</time_frame>
    <description>HRQoL will be measured by using the Chinese version of the SF-36.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>From the baseline to 12 weeks and 24 weeks</time_frame>
    <description>Weight in kilograms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>From the baseline to 12 weeks and 24 weeks</time_frame>
    <description>Height in meters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>From the baseline to 12 weeks and 24 weeks</time_frame>
    <description>Waist in cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip circumference</measure>
    <time_frame>From baseline to 12 weeks and 24 weeks</time_frame>
    <description>Hip circumference in cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent body fat</measure>
    <time_frame>From the baseline to 12 weeks and 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Session attendance rate</measure>
    <time_frame>From baseline to 12 weeks</time_frame>
    <description>Number of participants who truly attend the Tai Chi training session divided by the total number of participants in that training session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>12 weeks after Tai Chi training</time_frame>
    <description>This is to measure the maintenance of Tai Chi practice</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>12 weeks after Tai Chi training</time_frame>
    <description>This is to measure the maintenance of Tai Chi practice</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participation rate</measure>
    <time_frame>At baseline assessment (4 weeks)</time_frame>
    <description>This outcome is measured by the eligible participants at baseline assessment divided by the subjects who register the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dropout rate</measure>
    <time_frame>From the baseline to 12 weeks and 24 weeks</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>During intervention period (12 weeks)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Migraine Disorder</condition>
  <arm_group>
    <arm_group_label>Tai Chi training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants in this arm will receive 12-week Tai Chi training (1 hour per day, 5 days per week).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting list control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tai Chi training</intervention_name>
    <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.</description>
    <arm_group_label>Tai Chi training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Waiting list control group</intervention_name>
    <description>At the end of the trial, participants in this arm will be offered Tai Chi training similar as Tai Chi training (TC) group.</description>
    <arm_group_label>Waiting list control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female, aged 18-65 years;&#xD;
&#xD;
          -  Have a clinical diagnosis of episodic migraine according to ICHD-II criteria at least&#xD;
             2 months prior to enrollment;&#xD;
&#xD;
          -  At least one of the following migraine characteristics is met: nausea, vomiting,&#xD;
             photophobia, or phonophobia;&#xD;
&#xD;
          -  Able to undertake designated level of Tai Chi exercise;&#xD;
&#xD;
          -  Live in Hong Kong, can read and speak Cantonese or Putonghua.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe migraine attacks with disabilities that cannot perform moderate intensity&#xD;
             physical activity;&#xD;
&#xD;
          -  Secondary headache and other neurological disease;&#xD;
&#xD;
          -  More than 5 days of non-migrainous headache per month;&#xD;
&#xD;
          -  Experience with Tai Chi practice after diagnosis of migraine;&#xD;
&#xD;
          -  Regular performance of Tai Chi or other body-mind exercises (yoga, biofeedback,&#xD;
             medication, etc.);&#xD;
&#xD;
          -  Undergoing other alternative therapeutic treatments during recruitment period, or&#xD;
             received other alternative therapeutic treatments in the past 12 weeks;&#xD;
&#xD;
          -  Pregnancy, lactation period, or currently using contraceptives;&#xD;
&#xD;
          -  Use of pharmacological prophylactic treatment for migraine in the past 12 weeks;&#xD;
&#xD;
          -  Drug abuse, take antipsychotic or antidepressant drugs, or take analgesics for other&#xD;
             chronic pain more than 3 days a month in the past 12 weeks;&#xD;
&#xD;
          -  Epilepsy, or have a psychiatric disease.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yao Jie Xie, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hong Kong Polytechnic University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Hong Kong Polytechnic University</name>
      <address>
        <city>Hung Hom</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>December 23, 2016</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>May 18, 2022</last_update_submitted>
  <last_update_submitted_qc>May 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hong Kong Polytechnic University</investigator_affiliation>
    <investigator_full_name>XIE Yao Jie Grace</investigator_full_name>
    <investigator_title>Research Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Migraine</keyword>
  <keyword>Tai Chi</keyword>
  <keyword>Prophylaxis</keyword>
  <keyword>Randomized controlled trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03015753
org study id: G-UA8P
nct id: NCT03015753
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: The difference in frequency of migraine attacks (the number of attacks per month)
time frame: From baseline to 12 weeks
measure: The proportion of responders
time frame: From baseline to 12 weeks
description: Defined as the proportion of patients with at least a 50% reduction of the number of attacks per month
measure: Duration of headache attack
time frame: From the baseline to 12 weeks and 24 weeks
measure: Intensity of headache
time frame: From the baseline to 12 weeks and 24 weeks
description: Intensity of headache will be measured by a Visual Analogue Scale.
measure: Stress status
time frame: From the baseline to 12 weeks and 24 weeks
description: The Perceived Stress Scale (PSS) will be used to measure the stress level.
measure: Sleep quality
time frame: From the baseline to 12 weeks and 24 weeks
description: The Chinese version of the Pittsburgh Sleep Quality Index (PSQI) will be used to measure the sleep quality.
measure: Sleep quantity
time frame: From the baseline to 12 weeks and 24 weeks
description: A 7-day daily sleep log will be used to measure the sleep quantity.
measure: Fatigue level
time frame: From the baseline to 12 weeks and 24 weeks
description: The Numeric Rating Scale-fatigue (NRS-fatigue) will be used to measure fatigue level.
measure: HRQoL
time frame: From the baseline to 12 weeks and 24 weeks
description: HRQoL will be measured by using the Chinese version of the SF-36.
measure: Weight
time frame: From the baseline to 12 weeks and 24 weeks
description: Weight in kilograms
measure: Height
time frame: From the baseline to 12 weeks and 24 weeks
description: Height in meters
measure: Waist circumference
time frame: From the baseline to 12 weeks and 24 weeks
description: Waist in cm
measure: Hip circumference
time frame: From baseline to 12 weeks and 24 weeks
description: Hip circumference in cm
measure: Percent body fat
time frame: From the baseline to 12 weeks and 24 weeks
measure: Session attendance rate
time frame: From baseline to 12 weeks
description: Number of participants who truly attend the Tai Chi training session divided by the total number of participants in that training session
measure: 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
description: This is to measure the maintenance of Tai Chi practice
measure: 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
description: This is to measure the maintenance of Tai Chi practice
measure: Participation rate
time frame: At baseline assessment (4 weeks)
description: This outcome is measured by the eligible participants at baseline assessment divided by the subjects who register the study
measure: Dropout rate
time frame: From the baseline to 12 weeks and 24 weeks
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
measure: Adverse events
time frame: During intervention period (12 weeks)
arm group label: Tai Chi training
arm group type: Experimental
description: The participants in this arm will receive 12-week Tai Chi training (1 hour per day, 5 days per week).
arm group label: Waiting list control group
arm group type: Other
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: Tai Chi training
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.
arm group label: Tai Chi training
intervention type: Other
intervention name: Waiting list control group
description: At the end of the trial, participants in this arm will be offered Tai Chi training similar as Tai Chi training (TC) group.
arm group label: Waiting list control group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Yao Jie Xie, PhD
role: Principal Investigator
affiliation: The Hong Kong Polytechnic University
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The Hong Kong Polytechnic University
investigator full name: XIE Yao Jie Grace
investigator title: Research Assistant Professor
mesh term: Migraine Disorders
sharing ipd: No