Value of Cardiac Rehabilitation on the Treatment of Cardiovascular Disease

Not Applicable

• Conditions: Cardiac Rehabilitation
• Interventions: Behavioral: cardiac rehabilitation

• Registration Number: NCT05320848
• Lead Sponsor: Shenzhen People's Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-08-04
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-08
• Last Update Submitted: 2022-04-08
• Study First Posted: 2022-04-11
• Last Update Posted: 2022-04-11
• Primary Completion: 2022-05-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	cardiac rehabilitation	the patients treated with cardiac rehabilitation intervention.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Shenzhen People's Hospital; 🇨🇳 Shenzhen, China