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Efficacy and Mechanism of TCCRP in Patients With Chronic Coronary Syndrome Under Fusion Cardiac Rehabilitation Model

  • Clinicaltrials.gov identifier

    NCT03936504

  • Recruitment Status

    Recruiting

  • First Posted

    May 3, 2019

  • Last update posted

    December 9, 2020

Study Description

Brief summary:

This study is a prospective, multi-center, randomized controlled clinical study. It developed an innovative Tai Chi Cardiac Rehabilitation Program (TCCRP) for patients with chronic coronary syndrome (CCS) and evaluated the efficacy, acceptability and safety of TCCRP on patients with CCS in order to explore the possible mechanism of its feasibility.

  • Condition or Disease:Coronary Heart Disease
    Chronic Coronary Syndrome
  • Intervention/Treatment: Behavioral: Control Group :conventional exercise rehabilitation programs (CERP)
    Behavioral: Experimental Group :Tai Chi cardiac rehabilitation program (TCCRP)
  • Phase: N/A

Detailed Description

This study is a prospective, multi-center, randomized controlled clinical trial of 100 participants with chronic coronary syndrome (CCS) that compares Tai Chi cardiac rehabilitation program (TCCRP) with conventional exercise rehabilitation programs (CERP), with an allocation ratio of 1:1. A total of 6 months study period, including 1 month in-hospital rehabilitation, 2 months home-based rehabilitation and 3 months follow-up. The main outcome indicators were measured at baseline, 1 month, 3 months and 6 months. The secondary outcome measures will be measured at baseline and at 3 months.

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 100 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Clinical Efficacy and Mechanism of Tai Chi Cardiac Rehabilitation Program(TCCRP) in Patients With Chronic Coronary Syndrome Under Fusion Cardiac Rehabilitation Model: a Randomized Controlled Trial
  • Actual Study Start Date: October 2019
  • Estimated Primary Completion Date: July 2021
  • Estimated Study Completion Date: October 2021

Arms and interventions

Arm Intervention/treatment
Active Comparator: Control Group
Group received conventional exercise rehabilitation programs (CERP).
Behavioral: Control Group :conventional exercise rehabilitation programs (CERP)
The participants in the control group will receive a conventional exercise rehabilitation programs (CERP) 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 aerobic radio 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(TCCRP).
Behavioral: Experimental Group :Tai Chi cardiac rehabilitation program (TCCRP)
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.

Outcome Measures

  • Primary Outcome Measures: 1. Change in score of Chinese Perceived Stress Scale (CPSS) [ Time Frame: baseline, 1 month, 3 months, 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, 1 month, 3 months and 6 months.
  • 2. Change in score of Medical Outcomes Study Questionnaire Short Form 36 Health Survey (36-Item Short Form Survey) [ Time Frame: baseline,1 month, 3 months, 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, 1 month, 3 months and 6 months.
  • 3. 6-minute walk test (6 MWT) [ Time Frame: baseline, 1 month, 3 months, 6months ]
    6-minute walk test (6 MWT). 6MWT measures the distance a patient can walk quickly on a flat, hard ground in 6 minutes. 6MWT will be evaluated at baseline, 1 month, 3 months and 6 months.
  • Secondary Outcome Measures: 1. Body fat rate [ Time Frame: baseline, 3 months ]
    Body fat rate will be tested by the Inbody770 at baseline and 3 months (at the end of the intervention) through bioelectrical impedance analysis.
  • 2. Peak oxygen uptake(VO2Peak) [ Time Frame: baseline, 3 months ]
    Cardiopulmonary exercise test (CPET) is an objective method being increasingly used in a wide spectrum of clinical practice for assessing the functional capacity of patient with coronary heart disease. Peak oxygen uptake(VO2Peak)will be tested by CPET at baseline and 3 months (at the end of the 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. Left ventricular ejection fraction(LVEF) [ 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 variability [ Time Frame: baseline, 3 months ]
    Heart rate variability will be assessed at baseline and at the end of the 3-month intervention.
  • 6. Low-density lipoprotein [ Time Frame: baseline, 3 months ]
    Low-density lipoprotein inspections will be tested at baseline and at the end of the 3-month intervention using an automatic biochemical analyzer.
  • 7. Testing of intestinal flora [ Time Frame: baseline, 3 months ]
    Intestinal flora tests will be evaluated at baseline and at the end of the 3-month intervention.
  • Other Outcome Measures: 1. Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: baseline, 3 months ]
    Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report measure. The GAD-7 asks how often participants have been bothered by anxiety symptoms in the past 2 weeks. Items are rated on a 4-point Likert scale indicating symptom frequency, ranging from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 21, with higher scores indicating GAD. According to the original authors, the total score can then be interpreted as indicating no/minimal anxiety (0-4), mild (5-9), moderate (10-14), or severe (15-21), with a reasonable cut-off value for identifying cases of GAD at 10 points. GAD-7 will be evaluated at baseline and at the end of the 3-month intervention.
  • 2. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: baseline, 3 months ]
    The Patient Health Questionnaire-9 (PHQ-9) is designed for use with adults in assessing and monitoring depression severity based on Diagnostic and Statistical Manual of Mental Disorders (4th ed.;DSM-IV); The PHQ-9 asks clients to check off the number of days they have been bothered by each of the PHQ-9 symptoms over the"last two weeks." The nine items, based on DSM criteria for diagnosis of depression, are used to generate scores of 0, 1, 2, or 3 to the response categories of "not at all," "several days," "more than half the days," and "nearly every day,". The higher the score, the more serious the depression. PHQ-9 will be evaluated at baseline and at the end of the 3-month intervention.

Eligibility Criteria

  • Ages Eligible for Study: 18 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;

9. Patients with gastrointestinal diseases, infectious diseases, renal insufficiency, and
a history of gastrointestinal surgery within one year

Contacts and Locations

Contacts

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

Locations

China
Beijing Water Conservancy Hospital
Beijing

China
Chinese PLA General Hospital
Beijing

China
Beijing Chaoyang District Anzhen Community Health Service Center
Beijing

Sponsors and Collaborators

Chinese PLA General Hospital

Beijing Normal University

Investigators

Principal Investigator: Jing Ma, doctor Department of Cardiology in Chinese PLA General Hospital

More Information