This randomized controlled trial was designed to compare the efficacy of a 12-week home-based telerehabilitation (HBTCR) program against traditional center-based cardiac rehabilitation (CBCR) and usual care in patients who have undergone coronary artery bypass grafting (CABG). The primary goal was to assess changes in cardiopulmonary function, measured by peak oxygen consumption (VO₂ peak), and exercise capacity, measured by the 6-minute walk test (6MWT), to determine if HBTCR is a viable alternative to CBCR.
While cardiac rehabilitation (CR) is a Class IA recommendation for patients after coronary artery bypass grafting (CABG) to improve long-term outcomes, participation in traditional center-based programs (CBCR) is low due to barriers like travel, cost, and scheduling. Home-based telerehabilitation (HBTCR) emerges as a potential solution. This study was a three-arm, prospective, single-center randomized controlled trial to rigorously evaluate if a structured HBTCR program is as effective as CBCR. A total of 110 patients, 4-8 weeks post-CABG, were randomized into three groups: HBTCR, CBCR, or a control group receiving usual care with educational pamphlets. The HBTCR group performed prescribed exercises at home, using wearable monitors and a mobile app, with weekly remote monitoring by a rehabilitation team. The CBCR group attended supervised sessions at the hospital three times a week. The control group received standard follow-up and educational materials. The interventions lasted 12 weeks, with assessments of cardiopulmonary function, exercise capacity, cardiac function, psychological status, and quality of life conducted at baseline and at 12 weeks. The study aimed to provide robust evidence for HBTCR as an effective alternative model of care for post-CABG rehabilitation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
110
A 12-week comprehensive cardiac rehabilitation program. The exercise prescription (frequency, intensity, duration, type) was based on a baseline cardiopulmonary exercise test, typically starting at 40-60% of heart rate reserve and increasing progressively. The program included aerobic and resistance training components. This intervention was delivered either remotely (HBTCR group) or in-person (CBCR group), three times per week.
Participants received routine follow-up and standard health education pamphlets covering topics such as medication adherence, diet, and general advice on physical activity, without a structured or monitored exercise plan.
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Change in Peak Oxygen Consumption (VO₂ peak)
Measured in mL/kg/min by cardiopulmonary exercise testing (CPET) on a treadmill using a symptom-limited protocol. The change from baseline to 12 weeks was assessed.
Time frame: Baseline, 12 weeks
Change in 6-Minute Walk Distance (6MWD)
Measured in meters, assessing the maximum distance a patient can walk in 6 minutes on a flat, hard surface. The change from baseline to 12 weeks was assessed.
Time frame: Baseline, 12 weeks
Change in Left Ventricular Ejection Fraction (LVEF)
Assessed as a percentage (%) by transthoracic echocardiography.
Time frame: Baseline, 12 weeks
Change in Forced Expiratory Volume in 1 second to Forced Vital Capacity Ratio (FEV1/FVC)
Measured by spirometry to assess pulmonary function.
Time frame: Baseline, 12 weeks
Change in Psychological Status (Anxiety)
Assessed using the Hamilton Anxiety Scale (HAMA). A lower score indicates less anxiety.
Time frame: Baseline, 12 weeks
Change in Psychological Status (Depression)
Assessed using the Hamilton Depression Scale (HAMD). A lower score indicates less depression.
Time frame: Baseline, 12 weeks
Change in Quality of Life
Measured using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), which assesses eight domains of health.
Time frame: Baseline, 12 weeks
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Change in Cardiac Index (CI)
Assessed non-invasively to measure cardiac output relative to body surface area.
Time frame: Baseline, 12 weeks
Adherence to Rehabilitation Program
Calculated as the percentage of completed sessions out of the 36 total prescribed sessions for the HBTCR and CBCR groups.
Time frame: Up to 12 weeks
Incidence of Major Adverse Events
Number of participants experiencing major adverse cardiovascular events (e.g., death, myocardial infarction, urgent revascularization).
Time frame: Up to 12 weeks
Change in Stroke Volume Index (SVI)
Assessed non-invasively to measure the volume of blood pumped from the ventricle per beat relative to body surface area.
Time frame: Baseline, 12 weeks
Change in Systemic Vascular Resistance Index (SVRI)
Assessed non-invasively to measure the resistance to blood flow offered by all systemic vasculature, indexed to body surface area.
Time frame: Baseline, 12 weeks