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Completed

NCT Number: NCT07232693

Telerehabilitation vs. Center-Based Rehab for Psychological Well-being After CABG

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.

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Key information

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

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Home-Based Telerehabilitation Cardiac Rehabilitation

Behavioral

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.

Usual Care

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

  3. Change in Left Ventricular Ejection Fraction (LVEF)

    Time frame: Baseline, 12 Weeks

    The change from baseline in LVEF, assessed by echocardiography. Unit: Percentage (%).

  4. 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.

Sponsors and collaborators

Lead sponsor

The First Hospital of Hebei Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2025
Registry last updated
Nov 18, 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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