Value of Cardiac Rehabilitation on the Treatment of Cardiovascular Disease

Study Overview
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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.

Official Title
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Value of Cardiac Rehabilitation on the Treatment of Cardiovascular Disease

Conditions
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Cardiac Rehabilitation

Intervention / Treatment
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* Behavioral: cardiac rehabilitation


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>the patients treated with cardiac rehabilitation intervention. | Behavioral: cardiac rehabilitation<br>* Cardiac rehabilitation is a valuable treatment for patients with a broad spectrum of cardiac disease.<br>|
| No Intervention: Control group<br>the patients treated without cardiac rehabilitation intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| first occurrence of major adverse cardiovascular events (MACE) | first occurrence of major adverse cardiovascular events (MACE) (composite of all-cause mortality, myocardial infarction, stroke, or emergency cardiovascular hospitalization) | 3 years | 
| maximum oxygen uptake | maximum oxygen uptake | 3 years |