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

NCT07243444 | Completed

• 1 other identifier: S00775-1
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• Change in Peak Oxygen Consumption (VO₂ peak)

  Measured in mL/kg/min by cardiopulmonary exercise testing (CPET) on a treadmill using a symptom-limited protocol. The change from baseline to 12 weeks was assessed.

  Baseline, 12 weeks

• Change in 6-Minute Walk Distance (6MWD)

  Measured in meters, assessing the maximum distance a patient can walk in 6 minutes on a flat, hard surface. The change from baseline to 12 weeks was assessed.

  Baseline, 12 weeks

Secondary Outcomes (10)

• Change in Left Ventricular Ejection Fraction (LVEF)

  Baseline, 12 weeks

• Change in Forced Expiratory Volume in 1 second to Forced Vital Capacity Ratio (FEV1/FVC)

  Baseline, 12 weeks

• Change in Psychological Status (Anxiety)

  Baseline, 12 weeks

• Change in Psychological Status (Depression)

  Baseline, 12 weeks

• Change in Quality of Life

  Baseline, 12 weeks

Study Arms (3)

Home-Based Telerehabilitation (HBTCR) Group

EXPERIMENTAL

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.

Behavioral: Structured Exercise Program

Center-Based Cardiac Rehabilitation (CBCR) Group

ACTIVE COMPARATOR

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.

Behavioral: Structured Exercise Program

Control Group

SHAM COMPARATOR

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.

Behavioral: Standard Health Education

Interventions

Structured Exercise Program BEHAVIORAL

A 12-week comprehensive cardiac rehabilitation program. The exercise prescription (frequency, intensity, duration, type) was based on a baseline cardiopulmonary exercise test, typically starting at 40-60% of heart rate reserve and increasing progressively. The program included aerobic and resistance training components. This intervention was delivered either remotely (HBTCR group) or in-person (CBCR group), three times per week.

Center-Based Cardiac Rehabilitation (CBCR) Group; Home-Based Telerehabilitation (HBTCR) Group

Standard Health Education BEHAVIORAL

Participants received routine follow-up and standard health education pamphlets covering topics such as medication adherence, diet, and general advice on physical activity, without a structured or monitored exercise plan.

Control Group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Hebei Medical University: lead

Study Sites (1)

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 21, 2025
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-10

Locations

CN (1)