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

NCT ID: NCT03936504

Last Updated: 2020-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-17

Study Completion Date

2021-10-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Heart Disease Chronic Coronary Syndrome

Keywords

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Tai Chi Cardiac rehabilitation Chronic coronary syndrome Safety Effectiveness Randomized controlled trial Fusion cardiac rehabilitation model

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Control Group

Group received conventional exercise rehabilitation programs (CERP).

Group Type ACTIVE_COMPARATOR

Control Group :conventional exercise rehabilitation programs (CERP)

Intervention Type BEHAVIORAL

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

Group received Tai Chi cardiac rehabilitation program(TCCRP).

Group Type EXPERIMENTAL

Experimental Group :Tai Chi cardiac rehabilitation program (TCCRP)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Normal University

OTHER

Sponsor Role collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jing Ma

Clincial professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jing Ma, doctor

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology in Chinese PLA General Hospital

Locations

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Beijing Water Conservancy Hospital

Beijing, , China

Site Status RECRUITING

Chinese PLA General Hospital

Beijing, , China

Site Status RECRUITING

Beijing Chaoyang District Anzhen Community Health Service Center

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ma Jing, doctor

Role: CONTACT

Phone: 13681257396

Email: [email protected]

Facility Contacts

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Lianshan Zhao

Role: primary

Jing Ma

Role: primary

Hua Li

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 29354065 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3240110 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 392869 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2257154 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6390610 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4432806 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27832671 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30496563 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27335689 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22267690 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23664441 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40553955 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32624473 (View on PubMed)

Related Links

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Other Identifiers

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S2019-060-03

Identifier Type: -

Identifier Source: org_study_id