Value of Cardiac Rehabilitation on the Treatment of Cardiovascular Disease

NCT ID: NCT05320848

Last Updated: 2022-04-11

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

2021-02-01

Study Completion Date

2025-02-01

Brief Summary

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Cardiac rehabilitation is a valuable treatment for patients with a broad spectrum of cardiac disease. Current guidelines support its use in patients after acute coronary syndrome, coronary artery bypass grafting, coronary stent placement, valve surgery, and stable chronic systolic heart failure. Its use in these conditions is supported by a robust body of research demonstrating improved clinical outcomes. Despite this evidence, cardiac rehabilitation referral and attendance remains low and interventions to increase its use need to be developed.

Detailed Description

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The trial was conducted in Shenzhen in China. This study will recruit 100 patients with cardiovascular disease with a median and minimum follow-up of 24 and 6 months. Patients will be individually randomized to receive either a cardiac rehabilitation program (n = 50) or enhanced standard care involving educational advice (n = 50). The co-primary outcomes are: 1) first occurrence of major adverse cardiovascular events (MACE) (composite of all-cause mortality, myocardial infarction, stroke, or emergency cardiovascular hospitalization); and 2) self-rated health on the Quality of Life-5 Dimensions-5 Level visual analogue scale.

Conditions

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Cardiac Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Treatment group

the patients treated with cardiac rehabilitation intervention.

Group Type EXPERIMENTAL

cardiac rehabilitation

Intervention Type BEHAVIORAL

Cardiac rehabilitation is a valuable treatment for patients with a broad spectrum of cardiac disease.

Control group

the patients treated without cardiac rehabilitation intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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cardiac rehabilitation

Cardiac rehabilitation is a valuable treatment for patients with a broad spectrum of cardiac disease.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Cardiovascular disease

Exclusion Criteria

* Incalculable TFC
* Coronary artery spasm or ectasia
* LV ejection fraction \< 52% in males or \< 54% in females
* Abnormal heart structure (congenital heart disease, cardiomyopathies, or valvular dysfunction)
* Pericardial disease (pericardial effusion or constrictive pericarditis)
* Previous history of myocardial infarction
* Uncontrolled hypertension (systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 105 mmHg)
* Hyperthyroidism
* Hypothyroidism
* Malignancy
* Autoimmune disease
* Infection
* Pulmonary, hepatic, and renal disorders
* Haematological disorders (anaemia, bone marrow involved by neoplastic disease, or red blood cell transfusions)
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shenzhen People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shenzhen People's Hospital

Shenzhen, , China

Site Status

Countries

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China

References

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Anderson L, Thompson DR, Oldridge N, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2016 Jan 5;2016(1):CD001800. doi: 10.1002/14651858.CD001800.pub3.

Reference Type BACKGROUND
PMID: 26730878 (View on PubMed)

Ruano-Ravina A, Pena-Gil C, Abu-Assi E, Raposeiras S, van 't Hof A, Meindersma E, Bossano Prescott EI, Gonzalez-Juanatey JR. Participation and adherence to cardiac rehabilitation programs. A systematic review. Int J Cardiol. 2016 Nov 15;223:436-443. doi: 10.1016/j.ijcard.2016.08.120. Epub 2016 Aug 13.

Reference Type BACKGROUND
PMID: 27557484 (View on PubMed)

Wong WP, Feng J, Pwee KH, Lim J. A systematic review of economic evaluations of cardiac rehabilitation. BMC Health Serv Res. 2012 Aug 8;12:243. doi: 10.1186/1472-6963-12-243.

Reference Type BACKGROUND
PMID: 22873828 (View on PubMed)

Ragupathi L, Stribling J, Yakunina Y, Fuster V, McLaughlin MA, Vedanthan R. Availability, Use, and Barriers to Cardiac Rehabilitation in LMIC. Glob Heart. 2017 Dec;12(4):323-334.e10. doi: 10.1016/j.gheart.2016.09.004. Epub 2017 Mar 13.

Reference Type BACKGROUND
PMID: 28302548 (View on PubMed)

Edwards K, Jones N, Newton J, Foster C, Judge A, Jackson K, Arden NK, Pinedo-Villanueva R. The cost-effectiveness of exercise-based cardiac rehabilitation: a systematic review of the characteristics and methodological quality of published literature. Health Econ Rev. 2017 Oct 19;7(1):37. doi: 10.1186/s13561-017-0173-3.

Reference Type BACKGROUND
PMID: 29052044 (View on PubMed)

Other Identifiers

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SY-CSF-001

Identifier Type: -

Identifier Source: org_study_id

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