- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07232693
Telerehabilitation vs. Center-Based Rehab for Psychological Well-being After CABG
November 14, 2025 updated by: Yan Liu, The First Hospital of Hebei Medical University
The Impact of Home-Based Telerehabilitation Versus Center-Based Cardiac Rehabilitation on Anxiety, Depression, and Quality of Life After Coronary Artery Bypass Grafting: A Randomized Controlled Trial
This randomized controlled trial aims to determine if a 12-week home-based telerehabilitation (HBTCR) program is as effective as traditional center-based cardiac rehabilitation (CBCR) in improving psychological well-being (anxiety and depression) and quality of life in patients who have undergone coronary artery bypass grafting (CABG).
A third group receiving usual care served as a control.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Psychological distress, such as anxiety and depression, is common after coronary artery bypass grafting (CABG) and negatively affects recovery and quality of life.
While center-based cardiac rehabilitation (CBCR) effectively addresses these issues, participation is often limited by barriers like travel, cost, and scheduling.
Home-based telerehabilitation (HBTCR) offers a potential solution.
This single-center, prospective, three-arm randomized controlled trial was designed to compare the effectiveness of HBTCR versus CBCR and usual care.
A total of 110 clinically stable patients, 4-8 weeks post-CABG, were randomly assigned in a 1:1:1 ratio to an HBTCR group, a CBCR group, or a control group.
The intervention period was 12 weeks.
The study hypothesized that the HBTCR program, which includes a personalized exercise plan, remote monitoring via a wearable device and mobile app, and weekly psychosocial support from a nurse, would be as effective as the traditional supervised in-person CBCR program in reducing symptoms of anxiety and depression and improving health-related quality of life.
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
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Shijiazhuang, Hebei, China, 050000
- The First Hospital of Hebei Medical University
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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:
- Aged 30-75 years.
- 4-8 weeks post-Coronary Artery Bypass Grafting (CABG).
- In clinically stable condition.
- Had access to a smartphone and were willing to use it for the program.
- Willing to participate in a 12-week rehabilitation program.
- Provided written informed consent.
Exclusion Criteria:
- Presence of severe and unstable comorbidities (e.g., uncontrolled heart failure, recent stroke).
- Severe orthopedic limitations that would prevent participation in exercise.
- Significant cognitive impairment or psychiatric disorders that would interfere with participation.
- Inability to provide informed consent.
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 exercise program to perform at home.
They were provided with a wearable heart rate monitor and a mobile application to log their activities.
A dedicated cardiac rehabilitation nurse contacted each patient weekly via phone or video call to review progress, adjust the exercise plan, and provide structured psychosocial support and counseling.
|
A 12-week structured and remotely monitored cardiac rehabilitation program including a personalized exercise prescription (aerobic and resistance training), remote monitoring with a wearable heart rate sensor and mobile app, and weekly one-on-one psychosocial support and counseling via phone or video call from a rehabilitation nurse.
|
|
Active Comparator: Center-Based Cardiac Rehabilitation (CBCR) Group
Participants attended 36 supervised sessions at the hospital's cardiac rehabilitation center over 12 weeks (3 sessions/week).
Each session included aerobic and resistance exercises.
In addition, patients attended weekly group sessions for health education and psychosocial support, covering topics like stress management and coping strategies.
|
A 12-week structured and remotely monitored cardiac rehabilitation program including a personalized exercise prescription (aerobic and resistance training), remote monitoring with a wearable heart rate sensor and mobile app, and weekly one-on-one psychosocial support and counseling via phone or video call from a rehabilitation nurse.
|
|
Sham Comparator: Control Group
Participants received usual care, which included standard postoperative medical advice and health education pamphlets detailing general recommendations for diet, medication, and physical activity.
They did not receive any structured exercise prescription or formal psychological support from the study team.
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Standard postoperative care including prescribed medications and routine follow-up, supplemented with health education pamphlets on lifestyle modification.
No structured or supervised rehabilitation was provided.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Anxiety Symptoms
Time Frame: Baseline, 12 Weeks
|
The change from baseline in the Hamilton Anxiety Scale (HAMA) score.
The HAMA scale is a clinician-rated scale where higher scores indicate greater symptom severity.
|
Baseline, 12 Weeks
|
|
Change in Depression Symptoms
Time Frame: Baseline, 12 Weeks
|
The change from baseline in the 17-item Hamilton Depression Scale (HAMD) score.
The HAMD is a clinician-rated scale where higher scores indicate greater symptom severity.
|
Baseline, 12 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Health-Related Quality of Life
Time Frame: Baseline, 12 Weeks
|
The change from baseline in scores on the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36).
The SF-36 assesses eight domains: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH).
Scores for each domain range from 0 to 100, with higher scores indicating better quality of life.
|
Baseline, 12 Weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Peak Oxygen Consumption (VO₂ peak)
Time Frame: Baseline, 12 Weeks
|
The change from baseline in VO₂ peak, a measure of cardiopulmonary fitness, assessed via an exercise test.
Unit: mL/kg/min.
|
Baseline, 12 Weeks
|
|
Change in 6-Minute Walk Distance (6MWD)
Time Frame: Baseline, 12 Weeks
|
The change from baseline in the distance a patient can walk in six minutes, measuring functional exercise capacity.
Unit: Meters.
|
Baseline, 12 Weeks
|
|
Change in Left Ventricular Ejection Fraction (LVEF)
Time Frame: Baseline, 12 Weeks
|
The change from baseline in LVEF, assessed by echocardiography.
Unit: Percentage (%).
|
Baseline, 12 Weeks
|
|
Adherence Rate
Time Frame: Through study completion, 12 weeks
|
The percentage of completed cardiac rehabilitation sessions out of the total prescribed sessions for the HBTCR and CBCR groups.
|
Through study completion, 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)
June 1, 2024
Primary Completion (Actual)
August 1, 2025
Study Completion (Actual)
August 1, 2025
Study Registration Dates
First Submitted
November 14, 2025
First Submitted That Met QC Criteria
November 14, 2025
First Posted (Actual)
November 18, 2025
Study Record Updates
Last Update Posted (Actual)
November 18, 2025
Last Update Submitted That Met QC Criteria
November 14, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S00775-2
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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