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Completed

NCT Number: NCT07243444

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

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.

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Key information

Conditions

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

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Peak Oxygen Consumption (VO₂ peak)

    Time frame: Baseline, 12 weeks

    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.

  2. Change in 6-Minute Walk Distance (6MWD)

    Time frame: Baseline, 12 weeks

    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.

Secondary outcomes

  1. Change in Left Ventricular Ejection Fraction (LVEF)

    Time frame: Baseline, 12 weeks

    Assessed as a percentage (%) by transthoracic echocardiography.

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

    Time frame: Baseline, 12 weeks

    Measured by spirometry to assess pulmonary function.

  3. Change in Psychological Status (Anxiety)

    Time frame: Baseline, 12 weeks

    Assessed using the Hamilton Anxiety Scale (HAMA). A lower score indicates less anxiety.

  4. Change in Psychological Status (Depression)

    Time frame: Baseline, 12 weeks

    Assessed using the Hamilton Depression Scale (HAMD). A lower score indicates less depression.

  5. Change in Quality of Life

    Time frame: Baseline, 12 weeks

    Measured using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), which assesses eight domains of health.

  6. Change in Cardiac Index (CI)

    Time frame: Baseline, 12 weeks

    Assessed non-invasively to measure cardiac output relative to body surface area.

  7. Adherence to Rehabilitation Program

    Time frame: Up to 12 weeks

    Calculated as the percentage of completed sessions out of the 36 total prescribed sessions for the HBTCR and CBCR groups.

  8. Incidence of Major Adverse Events

    Time frame: Up to 12 weeks

    Number of participants experiencing major adverse cardiovascular events (e.g., death, myocardial infarction, urgent revascularization).

  9. Change in Stroke Volume Index (SVI)

    Time frame: Baseline, 12 weeks

    Assessed non-invasively to measure the volume of blood pumped from the ventricle per beat relative to body surface area.

  10. Change in Systemic Vascular Resistance Index (SVRI)

    Time frame: Baseline, 12 weeks

    Assessed non-invasively to measure the resistance to blood flow offered by all systemic vasculature, indexed to body surface area.

Sponsors and collaborators

Lead sponsor

The First Hospital of Hebei Medical University

Other

Registry information

Official study title

Efficacy of Home-Based Telerehabilitation Versus Center-Based Cardiac Rehabilitation on Cardiopulmonary Function and Exercise Capacity in Patients After Coronary Artery Bypass Grafting: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 21, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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