<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/NCT03016585</url>
  </required_header>
  <id_info>
    <org_study_id>PusanNU</org_study_id>
    <nct_id>NCT03016585</nct_id>
  </id_info>
  <brief_title>Effectiveness of Tai Chi on Cardiac Autonomic Function and Symptomatology in Women With Fibromyalgia: a Randomized Controlled Trial</brief_title>
  <official_title>Effectiveness of Tai Chi on Cardiac Autonomic Function and Symptomatology in Women With Fibromyalgia: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pusan National University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Marymount University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Pusan National University</source>
  <brief_summary>
    <textblock>
      Fibromyalgia (FM) is an idiopathic disease affecting approximately 3% of the world&#xD;
      population, primarily diagnosed in middle-aged women. Although FM is mainly characterized by&#xD;
      chronic pain and fatigue, reduced muscular strength and flexibility are common symptoms&#xD;
      associated with the presentation of the disorder. Interestingly, the etiology and underlying&#xD;
      mechanism of FM are not completely understood, but previous findings suggest that autonomic&#xD;
      dysfunction may explain some of the FM symptoms.&#xD;
&#xD;
      Compared to age-matched healthy individuals, patients with FM have an attenuated autonomic&#xD;
      function which is associated with a reduction in vagal tone and increase in sympathetic&#xD;
      activity. Therefore, autonomic function is a worthwhile target intervention in individuals&#xD;
      with FM. Although traditional exercise ( both aerobic and resistance) has been shown to&#xD;
      effectively improve HRV parameters and FM symptoms, most FM patients display a decline in&#xD;
      adherence to traditional exercise and continue to experience considerable pain and fatigue&#xD;
      years after the original diagnosis ultimately requiring medication to control their&#xD;
      symptoms.Thus, new approaches are needed to improve autonomic function and clinical symptoms&#xD;
      in patients with FM, which will ultimately improve their physical and emotional functioning&#xD;
      leading to a better quality of life.&#xD;
&#xD;
      Tai Chi (TC) is a form of ancient Chinese martial art which integrates slow movements,&#xD;
      controlled breathing and mental concentration. TC training is safe for special populations&#xD;
      and has previously shown to decrease pain, fatigue as well as other FM related&#xD;
      symptoms.However, the potential role of TC training on autonomic function is largely&#xD;
      unexplored.&#xD;
&#xD;
      The investigators hypothesis is that 12 weeks of TC training would improve our primary&#xD;
      outcome of autonomic function through improvements in sympathovagal balance, and the&#xD;
      secondary outcomes measures of FM symptoms (pain, fatigue and sleep quality), strength and&#xD;
      flexibility.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to examine the effects of 12 weeks of TC training on on cardiac&#xD;
      autonomic function, FM symptoms (pain, fatigue and sleep quality), strength and flexibility.&#xD;
      The specific aim of the study is:&#xD;
&#xD;
      - To evaluate the effects of 12 weeks of TC training on autonomic function arterial function&#xD;
      by assessing heart rate variability&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Autonomic Function</measure>
    <time_frame>12 weeks</time_frame>
    <description>Heart Rate Variability was assessed from electrocardiogram</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fibromyalgia Symptomatology</measure>
    <time_frame>12 weeks</time_frame>
    <description>Subjects filled visual analog scales (VAS) to evaluate symptom severity before and after 12 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Flexibilty</measure>
    <time_frame>12 weeks</time_frame>
    <description>Flexibility was measured using the Sit and Reach Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle Strength</measure>
    <time_frame>12 weeks</time_frame>
    <description>one repetition maximum (1RM) was performed using a leg extension machine</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>Tai Chi Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tai Chi exercises 3 times per wk for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This arm involves not making any change to the subject's lifestyle at the moment of the start of the intervention and for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tai Chi Training</intervention_name>
    <description>Participants practiced, under supervised instruction, 10 forms from the classic Yang style of Tai Chi 3 times per wk for 12 weeks.The Tai Chi sessions lasted approximately 55 minutes and included a 10-minute warm up, 40 minutes of practice and exercise finalizing with a 5-minute cooldown period.</description>
    <arm_group_label>Tai Chi Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fibromyalgia&#xD;
&#xD;
          -  Sedentary&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known pulmonary, cardiovascular, renal, adrenal, pituitary, severe psychiatric or&#xD;
             thyroid diseases.&#xD;
&#xD;
          -  Use of hormone replacement therapy during the 6 months prior to the study.&#xD;
&#xD;
          -  Any medication changes in the previous 12 months.&#xD;
&#xD;
          -  Current participation in psychological or physical therapy&#xD;
&#xD;
          -  History of steady exercise or received exercise training in the last year&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 8, 2017</study_first_submitted>
  <study_first_submitted_qc>January 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>October 30, 2020</last_update_submitted>
  <last_update_submitted_qc>October 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pusan National University</investigator_affiliation>
    <investigator_full_name>Won-mok son</investigator_full_name>
    <investigator_title>Ph.D</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
  </condition_browse>
  <!-- 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/NCT03016585
org study id: PusanNU
nct id: NCT03016585
lead sponsor: 
collaborator: 
Fibromyalgia (FM) is an idiopathic disease affecting approximately 3% of the world
      population, primarily diagnosed in middle-aged women. Although FM is mainly characterized by
      chronic pain and fatigue, reduced muscular strength and flexibility are common symptoms
      associated with the presentation of the disorder. Interestingly, the etiology and underlying
      mechanism of FM are not completely understood, but previous findings suggest that autonomic
      dysfunction may explain some of the FM symptoms.

      Compared to age-matched healthy individuals, patients with FM have an attenuated autonomic
      function which is associated with a reduction in vagal tone and increase in sympathetic
      activity. Therefore, autonomic function is a worthwhile target intervention in individuals
      with FM. Although traditional exercise ( both aerobic and resistance) has been shown to
      effectively improve HRV parameters and FM symptoms, most FM patients display a decline in
      adherence to traditional exercise and continue to experience considerable pain and fatigue
      years after the original diagnosis ultimately requiring medication to control their
      symptoms.Thus, new approaches are needed to improve autonomic function and clinical symptoms
      in patients with FM, which will ultimately improve their physical and emotional functioning
      leading to a better quality of life.

      Tai Chi (TC) is a form of ancient Chinese martial art which integrates slow movements,
      controlled breathing and mental concentration. TC training is safe for special populations
      and has previously shown to decrease pain, fatigue as well as other FM related
      symptoms.However, the potential role of TC training on autonomic function is largely
      unexplored.

      The investigators hypothesis is that 12 weeks of TC training would improve our primary
      outcome of autonomic function through improvements in sympathovagal balance, and the
      secondary outcomes measures of FM symptoms (pain, fatigue and sleep quality), strength and
      flexibility.
The purpose of this study is to examine the effects of 12 weeks of TC training on on cardiac
      autonomic function, FM symptoms (pain, fatigue and sleep quality), strength and flexibility.
      The specific aim of the study is:

      - To evaluate the effects of 12 weeks of TC training on autonomic function arterial function
      by assessing heart rate variability
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Autonomic Function
time frame: 12 weeks
description: Heart Rate Variability was assessed from electrocardiogram
measure: Fibromyalgia Symptomatology
time frame: 12 weeks
description: Subjects filled visual analog scales (VAS) to evaluate symptom severity before and after 12 weeks.
measure: Flexibilty
time frame: 12 weeks
description: Flexibility was measured using the Sit and Reach Test
measure: Muscle Strength
time frame: 12 weeks
description: one repetition maximum (1RM) was performed using a leg extension machine
arm group label: Tai Chi Training
arm group type: Experimental
description: Tai Chi exercises 3 times per wk for 12 weeks
arm group label: Control
arm group type: No Intervention
description: This arm involves not making any change to the subject's lifestyle at the moment of the start of the intervention and for 12 weeks.
intervention type: Other
intervention name: Tai Chi Training
description: Participants practiced, under supervised instruction, 10 forms from the classic Yang style of Tai Chi 3 times per wk for 12 weeks.The Tai Chi sessions lasted approximately 55 minutes and included a 10-minute warm up, 40 minutes of practice and exercise finalizing with a 5-minute cooldown period.
arm group label: Tai Chi Training
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Pusan National University
investigator full name: Won-mok son
investigator title: Ph.D
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes