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

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

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

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:

  • 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

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 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.
Behavioral: Home-Based Telerehabilitation Cardiac Rehabilitation
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.
Behavioral: Home-Based Telerehabilitation Cardiac Rehabilitation
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.
Behavioral: Usual Care
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

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 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

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 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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

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.
June 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.
August 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.
August 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 14, 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 18, 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 18, 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 14, 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.
November 1, 2025

More Information

Terms related to this study

Keywords

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.
  • S00775-2

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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