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Effects of Tai Chi Cardiac Rehabilitation Program on Safety and Effectiveness for Patients With Coronary Heart Disease

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ClinicalTrials.gov Identifier: NCT03936504
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : December 3, 2019
Sponsor:
Collaborator:
Beijing Normal University
Information provided by (Responsible Party):
Jing Ma, Chinese PLA General Hospital

Brief Summary:
This study is a prospective, multicenter, randomized controlled clinical study develop an innovative Tai Chi cardiac rehabilitation program (TCCRP) for patients with coronary heart disease(CHD), and assess the efficacy, safety, and acceptability of the Tai Chi cardiac rehabilitation program for patients coronary heart disease.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Behavioral: Control Group :conventional exercise rehabilitation Behavioral: Experimental Group :Tai Chi cardiac rehabilitation program Not Applicable

Detailed Description:
The investigators will conduct a prospective multicenter randomized‐controlled clinical trial of 150 participants with coronary heart disease(CHD). Patients will be randomly assigned in a 1:1 ratio into either a intervention group and a control group. The intervention group will participate in supervised Tai Chi cardiac rehabilitation program (TCCRP) held three times a week for 3 months. The control group will receive supervised conventional exercise rehabilitation held three times a week for 3 months. After the 3-month intervention period, there will be a 3-month follow-up period with no active intervention in either group. The primary and secondary outcomes will be assessed at baseline, 1 months, 3 months, and 6months. Primary outcome measures will be a score of 36-Item Short Form Survey (SF-36), and Chinese Perceived Stress Scale (CPSS). The secondary outcome measures will include the body composition, cardiopulmonary exercise test, respiratory muscle function, kinetism , echocardiogram and New York Heart Association (NYHA) classification, heart rate recovery time, laboratory examination . Other indicators include Seattle Angina Scale (SAQ), Pittsburgh Sleep Quality Index (PSQI), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), Berg Balance Scale (BBS),Morse Fall Seale (MFS), and Kansas city cardlomyopathy questionnaire (KCCQ) . Furthermore, adverse events will be recorded and analyzed. If any participants withdraw from the trial, intention-to-treat analysis will be performed.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Tai Chi Cardiac Rehabilitation Program on Safety and Effectiveness for Patients With Coronary Heart Disease: a Randomized Controlled Trial
Actual Study Start Date : October 17, 2019
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control Group
Group received conventional exercise rehabilitation
Behavioral: Control Group :conventional exercise rehabilitation
The participants in the control group will receive a conventional exercise rehabilitation thrice a week for 12 weeks. Each training session lasts for 60 minutes, including ordinary warm-up exercises(10 minutes), aerobic activity (30 minutes), resistive exercise (10 minutes), and cool-down exercises(10 minutes). Each training session includes:(1) an active warm-up including arm-swinging, gentle stretches of the neck, shoulders, spine, arms, legs and so on;(2) aerobic activity mainly including cycle ergometer exercise;(3) resistive exercise mainly including elastic belt exercise;(4) cool-down session involving active and static stretching exercises with primary body movements.

Experimental: Experimental Group
Group received Tai Chi cardiac rehabilitation program
Behavioral: Experimental Group :Tai Chi cardiac rehabilitation program
Participants perform Tai Chi cardiac rehabilitation program(TCCRP) thrice a week for 12 weeks. Each training session lasts for 60 minutes, including Tai Chi warm-up exercises(10 minutes), Bafa Wubu of Tai Chi(30 minutes), Tai-Chi in conjunction with X-light-band resistance exercise(10 minutes), and Tai Chi cool-down exercises(10 minutes). All participants are encouraged to practice Tai Chi followed the instructional video until finishing 12-week exercise.




Primary Outcome Measures :
  1. Change in score of Chinese Perceived Stress Scale (CPSS) [ Time Frame: baseline,3,6 months ]
    Chinese Perceived Stress Scale is a self-rated questionnaire, which assesses perceived stress. Chinese Perceived Stress Scale is consisted of 14 items, which are divided into two dimensions: sense of tension and loss of control. Higher scores indicate higher levels of stress,lower scores indicate lower levels of stress. Chinese Perceived Stress Scale will be evaluated at baseline, 1month, at the end of the 12-week intervention, and follow-up 3 months.

  2. Change in score of Medical Outcomes Study Questionnaire Short Form 36 Health Survey (36-Item Short Form Survey) [ Time Frame: baseline,3,6 months ]
    SF-36 Health Survey(SF-36) . This is a multi-purpose, short-form health survey with only 36 questions. SF-36 items cover eight domains: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems and mental health. Higher scores indicate higher levels of health. SF-36 will be evaluated at baseline, 1month, at the end of the 12-week intervention, and follow-up 3 months.


Secondary Outcome Measures :
  1. Body composition [ Time Frame: baseline,3 months ]
    Body composition measurements will include fat mass, body fat (percentage), fat-free mass and lean body mass. These measurements will be taken by bioelectrical impedance analysis using an Inbody 770 (Biospace Co) at baseline, 1 month, 3 months (at the end of intervention) and 6 months (at the 3-month follow-up).

  2. Cardiopulmonary exercise test (CPET) [ Time Frame: baseline, 3 months ]
    CPET is an objective method being increasingly used in a wide spectrum of clinical practice for assessing the functional capacity of CHD patient. Indexes include changes in VO2 peak, and VAT, and VE/ VCO2 slope in the cardiopulmonary exercise test (CPET) after the 12-week intervention.

  3. Locomotor skills [ Time Frame: baseline,3 months ]
    Locomotor skills includes handgrip strength, balance and flexibility. Handgrip strength, which is used to determine the maximum isometric strength of the hand and forearm muscles, will be measured using the handgrip strength dynamometer produced by CAMRY (product type EH101). The best result from repeated tests of each hand will be recorded. The balance test mainly includes standing on one foot with eyes closed, standing on one foot with eyes open, standing in situ with closed eyes and so on. Flexibility will be measured by seated forward flexion test. Locomotor skills will be evaluated at baseline and at the end of the 3-month intervention.

  4. Echocardiogram [ Time Frame: baseline, 3 months ]
    LVED Vi and LVEF are also to be assessed using echocardiography at baseline and at the end of the 12-week intervention.

  5. Heart rate recovery time [ Time Frame: baseline, 3 months ]
    Heart rate recovery time records heart rate 1 to 6 minutes after Tai Chi exercise, power cycling and resistance exercise.

  6. Laboratory examination [ Time Frame: baseline, 3 months ]
    A laboratory examination will be performed that includes glycolipid metabolism, inflammatory factor level, immunologic function and oxidative stress index. The laboratory examination will be evaluated at baseline and at the end of the 3-month intervention.


Other Outcome Measures:
  1. Berg balance scale (BBS) [ Time Frame: baseline,3months ]
    This is a widely used clinical test of a person's static and dynamic balance abilities, which comprises a set of 14 simple balance related tasks, ranging from standing up from a sitting position, to standing on one foot. Total score ranges from 0 to 56, with 0 to 20 corresponding to a high fall risk, 21 to 40 a medium fall risk, and 41 to 56 a low fall risk. BBS will also be evaluated at baseline and at the end of the 12-week intervention.

  2. Pittsburgh Sleep Quality Index(PSQI) [ Time Frame: baseline,3months ]
    This is a self-rated questionnaire, which assesses sleep quality and disturbances. It contains 19 questions answered by the subject themselves and 5 questions answered by the bed partner or roommate (if one is available). The scores from seven domains are added to calculate the index, which ranges from 0 to 21. A score of zero indicates no disturbance in sleep or good sleep quality, whereas higher scores indicate poorer sleep quality. PSQI will also be evaluated at baseline and at the end of the 12-week intervention.

  3. Patient Health Questionnaire-9(PHQ-9) and Generalized Anxiety Disorder-7(GAD-7) [ Time Frame: baseline,3months ]
    Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 are validated, self-report questionnaires that assess levels of depression and anxiety. Higher scores reflect greater levels of anxiety and depression. Lower scores reflect lower levels of anxiety and depression. Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 also be evaluated at baseline and at the end of the 12-week intervention.

  4. Seattle Angina Scale (SAQ) [ Time Frame: baseline,3months ]
    The Seattle Angina Score will be used to determine the total number of 9 problems and the 5 aspects of Coronary Heart Disease, including the degree of physical activity, the stability and frequency of angina, the degree of satisfaction of the treatment, and the perception of the disease. The higher the score, the better the quality of life and body function. The lower the score, the lower the quality of life and body function. The Seattle Angina Score will be measured at baseline and at the end of the 3-month intervention.

  5. Adverse events [ Time Frame: baseline,1, 3months ]
    A record will be made of any side effects and possible adverse reactions arising from the intervention (e.g., "Number of additional cardiovascular events", "Number of rehospitalization").



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Male or non-pregnant women aged from 18 to 80 years;
  2. Patients who met the stable angina pectoris in accordance with coronary heart disease;
  3. NYHA class Ι, Π or Ш;
  4. Participants were able to understand the purpose of clinical trials and voluntarily participate and sign informed consent.

Exclusion criteria

  1. Acute myocardial infarction (AMI) within 2 weeks;
  2. Severe aortic stenosis;
  3. Hypertrophic cardiomyopathy;
  4. Severe valvular heart disease;
  5. Malignant tachyarrhythmia;
  6. The patient compliance was poor and the clinical trial could not be completed according to the requirements.
  7. Combined exercise can cause deterioration of the nervous system, motor system disease, or rheumatic disease.
  8. In the past 3 months, those who regularly practice Tai Chi;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03936504


Contacts
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Contact: Ma Jing, doctor 13681257396 crystalma@126.com

Locations
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China
Beijing Water Conservancy Hospital Recruiting
Beijing, China, 100036
Contact: Lianshan Zhao         
Chinese PLA General Hospital Recruiting
Beijing, China, 100853
Contact: Jing Ma         
Beijing Chaoyang District Anzhen Community Health Service Center Recruiting
Beijing, China
Contact: Hua Li         
Sponsors and Collaborators
Chinese PLA General Hospital
Beijing Normal University
Investigators
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Principal Investigator: Jing Ma, doctor Department of Cardiology in Chinese PLA General Hospital
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jing Ma, Clincial professor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03936504    
Other Study ID Numbers: S2019-060-02
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 6 months after republication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: starting 6 months after publication
Access Criteria: The IPD of the publication will be shared, including characteristic data,results, clinical follow up data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jing Ma, Chinese PLA General Hospital:
Tai Chi
Cardiac rehabilitation
Coronary heart disease
Safety
Effectiveness
Randomized controlled trial
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases