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Coronary Heart DiseaseNCT03936504

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

A study testing Experimental Group :Tai Chi cardiac rehabilitation program (TCCRP) in people with Coronary Heart Disease and Chronic Coronary Syndrome, run by Chinese PLA General Hospital at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Experimental Group :Tai Chi cardiac rehabilitation program (TCCRP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
3 sitesChina
Study dates
17 Oct 2019to 30 Oct 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Acute myocardial infarction (AMI) within 2 weeks;
  • Severe aortic stenosis;
  • Hypertrophic cardiomyopathy;
  • Severe valvular heart disease;
  • Malignant tachyarrhythmia;
  • The patient compliance was poor and the clinical trial could not be completed according to the requirements.
Show all 9Show fewer
  • Combined exercise can cause deterioration of the nervous system, motor system disease, or rheumatic disease.
  • In the past 3 months, those who regularly practice Tai Chi;
  • Patients with gastrointestinal diseases, infectious diseases, renal insufficiency, and a history of gastrointestinal surgery within one year

Trial locations and contacts

3 sites in 1 country.

Ma Jing, doctor contact

13681257396

crystalma@126.com

China3 sites, 3 recruiting
  • Beijing Water Conservancy Hospital

    Beijing, 100036

    Lianshan Zhao

    Recruiting
  • Chinese PLA General Hospital

    Beijing, 100853

    Jing Ma

    Recruiting
  • Beijing Chaoyang District Anzhen Community Health Service Center

    Beijing

    Hua Li

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Control Group :conventional exercise rehabilitation programs (CERP), Experimental Group :Tai Chi cardiac rehabilitation program (TCCRP)
Keywords
Tai Chi, Cardiac rehabilitation, Chronic coronary syndrome, Safety, Effectiveness, Randomized controlled trial, Fusion cardiac rehabilitation model
Medical subject headings
Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control Group :conventional exercise rehabilitation programs (CERP)Behavioural

    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 Group :Tai Chi cardiac rehabilitation program (TCCRP)Behavioural

    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.

Study groups in NCT03936504
Study groupRoleWhat they receive
Control GroupActive comparatorGroup received conventional exercise rehabilitation programs (CERP).
Receives: Behavioral: Control Group :conventional exercise rehabilitation programs (CERP)
Experimental GroupExperimentalGroup received Tai Chi cardiac rehabilitation program(TCCRP).
Receives: Behavioral: Experimental Group :Tai Chi cardiac rehabilitation program (TCCRP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change 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.

    Measured: baseline, 1 month, 3 months, 6 months

  2. 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.

    Measured: baseline,1 month, 3 months, 6 months

  3. 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.

    Measured: baseline, 1 month, 3 months, 6months

Secondary outcomes (7)
  1. 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.

    Measured: baseline, 3 months

  2. 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).

    Measured: baseline, 3 months

  3. 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.

    Measured: baseline,3 months

  4. 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.

    Measured: baseline, 3 months

  5. Heart rate variability

    Heart rate variability will be assessed at baseline and at the end of the 3-month intervention.

    Measured: baseline, 3 months

  6. 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.

    Measured: baseline, 3 months

  7. Testing of intestinal flora

    Intestinal flora tests will be evaluated at baseline and at the end of the 3-month intervention.

    Measured: baseline, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2019
  2. Study start17 Oct 2019
  3. Primary completion30 Jul 2021 (estimated)
  4. Study completion30 Oct 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03936504
Sponsor's protocol ID
S2019-060-03
Status last verified
Dec 2020
First submitted
1 May 2019
Last updated
9 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 6 months after republication

Publications

  • Yang YL, Wang YH, Wang SR, Shi PS, Wang C. The Effect of Tai Chi on Cardiorespiratory Fitness for Coronary Disease Rehabilitation: A Systematic Review and Meta-Analysis. Front Physiol. 2018 Jan 4;8:1091. doi: 10.3389/fphys.2017.01091. eCollection 2017.

    PubMed 29354065
  • Pozzan R, Da Cruz P di M, Castier MB, Barbosa EC, Barbosa JS, Da Rocha PJ, Albanesi Filho FM, Ginefra P, Gomes Filho JB. [Cardiac rehabilitation of patients with coronary disease. Evaluation after 3 and 6 months of aerobic training at the community level]. Arq Bras Cardiol. 1988 May;50(5):305-10. No abstract available. Portuguese.

    PubMed 3240110
  • Ferguson RJ, Bourassa MG, Cote P, Chaitman BR. [Cardiovascular effects of exercise and physical training in coronary disease]. Union Med Can. 1979 Oct;108(10):1187-94. No abstract available. French.

    PubMed 392869
  • Fernandes F, Morais C, Esteves M, Camilo V, Nazare J, da Cunha JC, Amram SS. [Atrial pacing and the exercise test in the evaluation of coronary disease. A comparative study]. Rev Port Cardiol. 1990 Sep;9(9):675-9. Portuguese.

    PubMed 2257154
  • Hartung GH. Diet and exercise in the regulation of plasma lipids and lipoproteins in patients at risk of coronary disease. Sports Med. 1984 Nov-Dec;1(6):413-8. doi: 10.2165/00007256-198401060-00001. No abstract available.

    PubMed 6390610
  • Ferguson RJ, Petitclerc R, Choquette G, Chaniotis L, Gauthier P, Huot R, Allard C, Jankowski L, Campeau L. Effect of physical training on treadmill exercise capacity, collateral circulation and progression of coronary disease. Am J Cardiol. 1974 Dec;34(7):764-9. doi: 10.1016/0002-9149(74)90693-6. No abstract available.

    PubMed 4432806
  • Lepretre PM, Ghannem M, Bulvestre M, Ahmaidi S, Delanaud S, Weissland T, Lopes P. Exercise-based Cardiac Rehabilitation in Coronary Disease: Training Impulse or Modalities? Int J Sports Med. 2016 Dec;37(14):1144-1149. doi: 10.1055/s-0042-112591. Epub 2016 Nov 10.

    PubMed 27832671
  • Sharma S, Malhotra A. Exercise testing and coronary disease: pushing fitness to higher peaks. Eur Heart J. 2019 May 21;40(20):1640-1642. doi: 10.1093/eurheartj/ehy777. No abstract available.

    PubMed 30496563
  • Caruso FR, Junior JC, Mendes RG, Sperling MP, Arakelian VM, Bassi D, Arena R, Borghi-Silva A. Hemodynamic and metabolic response during dynamic and resistance exercise in different intensities: a cross-sectional study on implications of intensity on safety and symptoms in patients with coronary disease. Am J Cardiovasc Dis. 2016 May 18;6(2):36-45. eCollection 2016.

    PubMed 27335689
  • Chow CK, Redfern J, Thiagalingam A, Jan S, Whittaker R, Hackett M, Graves N, Mooney J, Hillis GS. Design and rationale of the tobacco, exercise and diet messages (TEXT ME) trial of a text message-based intervention for ongoing prevention of cardiovascular disease in people with coronary disease: a randomised controlled trial protocol. BMJ Open. 2012 Jan 19;2(1):e000606. doi: 10.1136/bmjopen-2011-000606. Print 2012.

    PubMed 22267690
  • Dominguez-Rodriguez A, Abreu-Gonzalez P. Microvascular coronary disease in women: role of the cardiopulmonary exercise testing. Int J Cardiol. 2013 Oct 3;168(3):3012-3. doi: 10.1016/j.ijcard.2013.04.055. Epub 2013 May 7. No abstract available.

    PubMed 23664441
  • Li Y, Li C, Wen J, Cui M, Wei Q, Liu M, Chen Z, Fang H, Liu L, Fu J, Zhang J, Lyu S. Tai Chi as a mind-body exercise modulates endothelial function in coronary artery disease: A randomized clinical trial. Complement Ther Med. 2025 Sep;92:103201. doi: 10.1016/j.ctim.2025.103201. Epub 2025 Jun 18.

    PubMed 40553955
  • Ma J, Zhang JW, Li H, Zhao LS, Guo AY, Chen ZH, Yuan W, Gao TM, Li YM, Li CH, Wang HW, Song B, Lu YL, Cui MZ, Wei QY, Lyu SJ, Yin HC. Safety and effectiveness of a Tai Chi-based cardiac rehabilitation programme for chronic coronary syndrom patients: study protocol for a randomised controlled trial. BMJ Open. 2020 Jul 5;10(7):e036061. doi: 10.1136/bmjopen-2019-036061.

    PubMed 32624473

Questions about this trial

What is this clinical trial studying?

A study testing Experimental Group :Tai Chi cardiac rehabilitation program (TCCRP) in people with Coronary Heart Disease and Chronic Coronary Syndrome, run by Chinese PLA General Hospital at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ma Jing, doctor (13681257396, crystalma@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in score of Chinese Perceived Stress Scale (CPSS) (time frame: baseline, 1 month, 3 months, 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03936504, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2020.

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