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

November 19, 2025 updated by: Yan Liu, The First Hospital of Hebei Medical University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • The First Hospital of Hebei Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Home-Based Telerehabilitation (HBTCR) Group
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
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.
Active Comparator: Center-Based Cardiac Rehabilitation (CBCR) Group
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
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.
Sham Comparator: Control Group
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 12 weeks
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.
Baseline, 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Left Ventricular Ejection Fraction (LVEF)
Time Frame: Baseline, 12 weeks
Assessed as a percentage (%) by transthoracic echocardiography.
Baseline, 12 weeks
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.
Baseline, 12 weeks
Change in Psychological Status (Anxiety)
Time Frame: Baseline, 12 weeks
Assessed using the Hamilton Anxiety Scale (HAMA). A lower score indicates less anxiety.
Baseline, 12 weeks
Change in Psychological Status (Depression)
Time Frame: Baseline, 12 weeks
Assessed using the Hamilton Depression Scale (HAMD). A lower score indicates less depression.
Baseline, 12 weeks
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.
Baseline, 12 weeks
Change in Cardiac Index (CI)
Time Frame: Baseline, 12 weeks
Assessed non-invasively to measure cardiac output relative to body surface area.
Baseline, 12 weeks
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.
Up to 12 weeks
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).
Up to 12 weeks
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.
Baseline, 12 weeks
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.
Baseline, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Hospital of Hebei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S00775-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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