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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
110
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.
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.
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
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.
Time frame: 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.
Time frame: Baseline, 12 Weeks
Change in Health-Related Quality of Life
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.
Time frame: Baseline, 12 Weeks
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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.