- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07243444
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
110
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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.
|
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
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
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.
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)
September 1, 2024
Primary Completion (Actual)
September 1, 2025
Study Completion (Actual)
September 1, 2025
Study Registration Dates
First Submitted
November 14, 2025
First Submitted That Met QC Criteria
November 19, 2025
First Posted (Actual)
November 21, 2025
Study Record Updates
Last Update Posted (Actual)
November 21, 2025
Last Update Submitted That Met QC Criteria
November 19, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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