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

NCT ID: NCT07232693

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-08-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Psychological Distress After Coronary Artery Bypass Grafting (CABG)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Home-Based Telerehabilitation Cardiac Rehabilitation

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Home-Based Telerehabilitation Cardiac Rehabilitation

Intervention Type 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.

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.

Group Type SHAM_COMPARATOR

Usual Care

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Hospital of Hebei Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yan Liu

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status

Countries

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China

Other Identifiers

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S00775-2

Identifier Type: -

Identifier Source: org_study_id

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