Home-Based Versus Center-Based Cardiac Rehabilitation After CABG Surgery

Hebei Medical University

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Behavioral: Standard Health Education; Behavioral: Structured Exercise Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07243444

S00775-1

Details and patient eligibility

About

This randomized controlled trial was designed to compare the efficacy of a 12-week home-based telerehabilitation (HBTCR) program against traditional center-based cardiac rehabilitation (CBCR) and usual care in patients who have undergone coronary artery bypass grafting (CABG). The primary goal was to assess changes in cardiopulmonary function, measured by peak oxygen consumption (VO₂ peak), and exercise capacity, measured by the 6-minute walk test (6MWT), to determine if HBTCR is a viable alternative to CBCR.

Full description

While cardiac rehabilitation (CR) is a Class IA recommendation for patients after coronary artery bypass grafting (CABG) to improve long-term outcomes, participation in traditional center-based programs (CBCR) is low due to barriers like travel, cost, and scheduling. Home-based telerehabilitation (HBTCR) emerges as a potential solution. This study was a three-arm, prospective, single-center randomized controlled trial to rigorously evaluate if a structured HBTCR program is as effective as CBCR. A total of 110 patients, 4-8 weeks post-CABG, were randomized into three groups: HBTCR, CBCR, or a control group receiving usual care with educational pamphlets. The HBTCR group performed prescribed exercises at home, using wearable monitors and a mobile app, with weekly remote monitoring by a rehabilitation team. The CBCR group attended supervised sessions at the hospital three times a week. The control group received standard follow-up and educational materials. The interventions lasted 12 weeks, with assessments of cardiopulmonary function, exercise capacity, cardiac function, psychological status, and quality of life conducted at baseline and at 12 weeks. The study aimed to provide robust evidence for HBTCR as an effective alternative model of care for post-CABG rehabilitation.

Enrollment: 110 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 30 to 75 years.
• Had undergone Coronary Artery Bypass Grafting (CABG) 4 to 8 weeks prior.
• In a stable clinical condition.
• Able to provide written informed consent.
• No cognitive impairments.

Exclusion criteria

• Acute decompensated heart failure.
• Severe physical comorbidities (e.g., fractures, severe hearing impairment) that would preclude participation in an exercise program.
• Recent stroke or pulmonary embolism.
• Significant hepatic or renal dysfunction.
• Unstable angina.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 3 patient groups

Home-Based Telerehabilitation (HBTCR) Group

Experimental group

Description:

Participants received a personalized 12-week cardiac rehabilitation program to perform at home. They were provided with a wearable heart rate monitor and used a mobile application to log their exercise sessions and vital signs. A rehabilitation team remotely monitored their progress and communicated weekly via phone or video call.

Treatment:

Behavioral: Structured Exercise Program

Center-Based Cardiac Rehabilitation (CBCR) Group

Active Comparator group

Description:

Participants attended supervised cardiac rehabilitation sessions at the hospital's rehabilitation center three times per week for 12 weeks. Each session included warm-up, aerobic exercise, resistance training, and cool-down under the direct supervision of a healthcare team.

Treatment:

Behavioral: Structured Exercise Program

Control Group

Sham Comparator group

Description:

Participants received usual care, which included routine follow-up appointments and standard health education delivered through verbal instructions and printed pamphlets. They did not participate in a structured or monitored exercise program.

Treatment:

Behavioral: Standard Health Education