Value of Cardiac Rehabilitation on the Treatment of Cardiovascular Disease

Southern University of Science and Technology

Status: Invitation-only

Conditions: Cardiac Rehabilitation

Treatments: Behavioral: cardiac rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05320848

SY-CSF-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Treatment group

Experimental group

Description:

the patients treated with cardiac rehabilitation intervention.

Treatment:

Behavioral: cardiac rehabilitation

Control group

No Intervention group

Description:

the patients treated without cardiac rehabilitation intervention.