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

NCT07232693 | Completed

• 1 other identifier: S00775-2
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psychological Distress After Coronary Artery Bypass Grafting (CABG)

Keywords

Coronary Artery Bypass Grafting; Telerehabilitation; Anxiety; Depression; Quality of Life; Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Change in Anxiety Symptoms

  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

  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 Outcomes (1)

• Change in Health-Related Quality of Life

  Baseline, 12 Weeks

Other Outcomes (4)

• Change in Peak Oxygen Consumption (VO₂ peak)

  Baseline, 12 Weeks

• Change in 6-Minute Walk Distance (6MWD)

  Baseline, 12 Weeks

• Change in Left Ventricular Ejection Fraction (LVEF)

  Baseline, 12 Weeks

Study Arms (3)

Home-Based Telerehabilitation (HBTCR) Group

EXPERIMENTAL

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

Center-Based Cardiac Rehabilitation (CBCR) Group

ACTIVE COMPARATOR

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

Control Group

SHAM COMPARATOR

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

Interventions

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.

Home-Based Telerehabilitation (HBTCR) Group

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.

Control Group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 30-75 years.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Hebei Medical University: lead

Study Sites (1)

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: June 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

CN (1)