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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
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.
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.
Beijing Water Conservancy Hospital
Beijing, China
RECRUITINGChinese PLA General Hospital
Beijing, China
RECRUITINGBeijing Chaoyang District Anzhen Community Health Service Center
Beijing, China
RECRUITINGChange in score of Chinese Perceived Stress Scale (CPSS)
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.
Time frame: baseline, 1 month, 3 months, 6 months
Change in score of Medical Outcomes Study Questionnaire Short Form 36 Health Survey (36-Item Short Form Survey)
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.
Time frame: baseline,1 month, 3 months, 6 months
6-minute walk test (6 MWT)
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.
Time frame: baseline, 1 month, 3 months, 6months
Body fat rate
Body fat rate will be tested by the Inbody770 at baseline and 3 months (at the end of the intervention) through bioelectrical impedance analysis.
Time frame: baseline, 3 months
Peak oxygen uptake（VO2Peak）
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).
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Time frame: baseline, 3 months
Locomotor skills
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.
Time frame: baseline，3 months
Left ventricular ejection fraction(LVEF)
LVED Vi and LVEF are also to be assessed using echocardiography at baseline and at the end of the 12-week intervention.
Time frame: baseline, 3 months
Heart rate variability
Heart rate variability will be assessed at baseline and at the end of the 3-month intervention.
Time frame: baseline, 3 months
Low-density lipoprotein
Low-density lipoprotein inspections will be tested at baseline and at the end of the 3-month intervention using an automatic biochemical analyzer.
Time frame: baseline, 3 months
Testing of intestinal flora
Intestinal flora tests will be evaluated at baseline and at the end of the 3-month intervention.
Time frame: baseline, 3 months