<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/NCT03229681</url>
  </required_header>
  <id_info>
    <org_study_id>20170506</org_study_id>
    <nct_id>NCT03229681</nct_id>
  </id_info>
  <brief_title>Baduanjin Exercise for Patients With Chronic Heart Failure on Phase II Cardiac Rehabilitation</brief_title>
  <acronym>BEPCR</acronym>
  <official_title>Baduanjin Exercise for Patients With Chronic Heart Failure on Phase II Cardiac Rehabilitation: A Prospective, Randomized, Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xiyuan Hospital of China Academy of Chinese Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xiyuan Hospital of China Academy of Chinese Medical Sciences</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic heart failure (CHF) is the end stage of various kinds of cardiovascular diseases with&#xD;
      high mortality. After a long period of medical treatment or surgical treatment, patients&#xD;
      suffered great pain physically and mentally. How to improve the quality of life and prognosis&#xD;
      in patients with CHF, which is a hot topic in the field of cardiac rehabilitation now.&#xD;
      Baduanjin, as one of the traditional Chinese qigong exercises, has the features of generous&#xD;
      stretch, soft consistency, dynamic but static, which is an appropriate movement pattern for&#xD;
      CHF patients.&#xD;
&#xD;
      To investigate the efficacy and safety of Baduanjin exercise for patients with coronary heart&#xD;
      disease complicated with chronic heart failure (CHF). A randomized, controlled and&#xD;
      prospective clinical trial was designed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 2, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2018</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Six-minute walk test（6MWT）</measure>
    <time_frame>Baseline, 3 months</time_frame>
    <description>Testing patients changes on walking distance and accompanies symptoms in 6 minutes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiopulmonary exercise test (CPET)</measure>
    <time_frame>Baseline, 3 months</time_frame>
    <description>CPET including peak VO2 (ml/kg/min)， AT，VE/VCO2, et,al.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left ventricular ejection fraction（LVEF）</measure>
    <time_frame>Baseline, 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left ventricular end-diastolic diameter (LVDD)</measure>
    <time_frame>Baseline, 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minnesota living with heart failure questionnaire (MLHFQ)</measure>
    <time_frame>Baseline, 3 months</time_frame>
    <description>Record the quality of life of patients with heart failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NT-proBNP</measure>
    <time_frame>Baseline, 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hs-CRP</measure>
    <time_frame>Baseline, 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HRV</measure>
    <time_frame>Baseline, 3 months</time_frame>
    <description>Mainly includes SDANN Index, SDNN Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiovascular events (MACE)</measure>
    <time_frame>Baseline, 3 months, 6months</time_frame>
    <description>Defined as death, myocardial infarction (MI), stroke and re-hospitalization related to cardiovascular disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NYHA classification</measure>
    <time_frame>Baseline, 3 months, 6months</time_frame>
    <description>The changes of heart function were compared after treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Main TCM symptoms</measure>
    <time_frame>Baseline, 3 months</time_frame>
    <description>The changes of scores of TCM syndromes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Rehabilitation With CHF; NYHA Class I or II</condition>
  <arm_group>
    <arm_group_label>Baduanjin exercise group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group received routine rehabilitation training and Baduanjin exercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine rehabilitation group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this group only received routine rehabilitation training</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Baduanjin exercise</intervention_name>
    <description>Participants in this groups received routine rehabilitation training and Baduanjin exercise. During the period of rehabilitation, physicians provides a wide range of medical, nutrition and mental health counseling, as well as rational drug-treatment. Baduanjin exercise protocol according to the &quot;Health Qigong Baduanjin Standard&quot; enacted by the General Administration of Sports in 2003. Due to the low-activity tolerance of CHF patients, we performed with a refined version of Baduanjin. Each Baduanjin exercise session lasts 45 minutes and continues twice per week for 12 weeks.</description>
    <arm_group_label>Baduanjin exercise group</arm_group_label>
    <other_name>Routine rehabilitation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Routine rehabilitation group</intervention_name>
    <description>Participants in this qroup only received the routine rehabilitation training. During the period of rehabilitation, physicians provides a wide range of medical, nutrition and mental health counseling, as well as rational drug-treatment. They should also come to rehabilitation center for physical exercise,45 minutes per day，twice per week, lasts 12 weeks.</description>
    <arm_group_label>Routine rehabilitation group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged from 40 to 75 years;&#xD;
&#xD;
          -  Diagnosed with chronic heart failure caused by coronary heart disease;&#xD;
&#xD;
          -  NYHA class I or II;&#xD;
&#xD;
          -  Patients with an ejection fraction (LVEF) more than 40%;&#xD;
&#xD;
          -  Participants in accordance with the guidelines define as stage II cardiac&#xD;
             rehabilitation;&#xD;
&#xD;
          -  Participants signed the informed consent freely and voluntarily.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The condition was serious or movement restrained by other diseases;&#xD;
&#xD;
          -  In the acute stage of chronic heart failure;&#xD;
&#xD;
          -  Participants with poorly control of blood pressure (SBP≥180mmHg or DBP≥100mmHg);&#xD;
&#xD;
          -  Resting heart rate is beating over 120 beats a minute, or merged with malignant&#xD;
             arrhythmia;&#xD;
&#xD;
          -  Participants who have contraindications to cardiopulmonary test or exercise training;&#xD;
&#xD;
          -  Patients who have other serious acute， chronic organic disease or mental disorders;&#xD;
&#xD;
          -  Participants practiced in any kinds of traditional Chinese medicine exercises in last&#xD;
             three months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hao Xu</last_name>
    <role>Study Director</role>
    <affiliation>Xiyuan Hospital of China Academy of Chinese Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Meili Yu</last_name>
    <phone>+86(010)62835341</phone>
    <email>woshananyang@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Xiyuan Hospital of China Academy of Chinese Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Meili Yu</last_name>
      <phone>+86(010)62835341</phone>
      <email>woshananyang@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 23, 2017</study_first_submitted>
  <study_first_submitted_qc>July 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>July 23, 2017</last_update_submitted>
  <last_update_submitted_qc>July 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Baduanjin; CHF; 6MWT; CPET</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03229681
org study id: 20170506
nct id: NCT03229681
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Chronic heart failure (CHF) is the end stage of various kinds of cardiovascular diseases with
      high mortality. After a long period of medical treatment or surgical treatment, patients
      suffered great pain physically and mentally. How to improve the quality of life and prognosis
      in patients with CHF, which is a hot topic in the field of cardiac rehabilitation now.
      Baduanjin, as one of the traditional Chinese qigong exercises, has the features of generous
      stretch, soft consistency, dynamic but static, which is an appropriate movement pattern for
      CHF patients.

      To investigate the efficacy and safety of Baduanjin exercise for patients with coronary heart
      disease complicated with chronic heart failure (CHF). A randomized, controlled and
      prospective clinical trial was designed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Six-minute walk test（6MWT）
time frame: Baseline, 3 months
description: Testing patients changes on walking distance and accompanies symptoms in 6 minutes
measure: Cardiopulmonary exercise test (CPET)
time frame: Baseline, 3 months
description: CPET including peak VO2 (ml/kg/min)， AT，VE/VCO2, et,al.
measure: Left ventricular ejection fraction（LVEF）
time frame: Baseline, 3 months
measure: Left ventricular end-diastolic diameter (LVDD)
time frame: Baseline, 3 months
measure: Minnesota living with heart failure questionnaire (MLHFQ)
time frame: Baseline, 3 months
description: Record the quality of life of patients with heart failure
measure: NT-proBNP
time frame: Baseline, 3 months
measure: hs-CRP
time frame: Baseline, 3 months
measure: HRV
time frame: Baseline, 3 months
description: Mainly includes SDANN Index, SDNN Index
measure: Major adverse cardiovascular events (MACE)
time frame: Baseline, 3 months, 6months
description: Defined as death, myocardial infarction (MI), stroke and re-hospitalization related to cardiovascular disease
measure: NYHA classification
time frame: Baseline, 3 months, 6months
description: The changes of heart function were compared after treatment
measure: The Main TCM symptoms
time frame: Baseline, 3 months
description: The changes of scores of TCM syndromes
arm group label: Baduanjin exercise group
arm group type: Experimental
description: Participants in this group received routine rehabilitation training and Baduanjin exercise
arm group label: Routine rehabilitation group
arm group type: Active Comparator
description: Participants in this group only received routine rehabilitation training
intervention type: Behavioral
intervention name: Baduanjin exercise
description: Participants in this groups received routine rehabilitation training and Baduanjin exercise. During the period of rehabilitation, physicians provides a wide range of medical, nutrition and mental health counseling, as well as rational drug-treatment. Baduanjin exercise protocol according to the "Health Qigong Baduanjin Standard" enacted by the General Administration of Sports in 2003. Due to the low-activity tolerance of CHF patients, we performed with a refined version of Baduanjin. Each Baduanjin exercise session lasts 45 minutes and continues twice per week for 12 weeks.
arm group label: Baduanjin exercise group
other name: Routine rehabilitation
intervention type: Behavioral
intervention name: Routine rehabilitation group
description: Participants in this qroup only received the routine rehabilitation training. During the period of rehabilitation, physicians provides a wide range of medical, nutrition and mental health counseling, as well as rational drug-treatment. They should also come to rehabilitation center for physical exercise,45 minutes per day，twice per week, lasts 12 weeks.
arm group label: Routine rehabilitation group
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Hao Xu
role: Study Director
affiliation: Xiyuan Hospital of China Academy of Chinese Medical Sciences
last name: Meili Yu
phone: +86(010)62835341
email: woshananyang@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: Undecided