Coronary Artery Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALStructured Exercise Program
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.
BEHAVIORALStandard Health Education
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.
Sponsors
The First Hospital of Hebei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 30 to 75 years. * Had undergone Coronary Artery Bypass Grafting (CABG) 4 to 8 weeks prior. * In a stable clinical condition. * Able to provide written informed consent. * No cognitive impairments.
Exclusion criteria
* Acute decompensated heart failure. * Severe physical comorbidities (e.g., fractures, severe hearing impairment) that would preclude participation in an exercise program. * Recent stroke or pulmonary embolism. * Significant hepatic or renal dysfunction. * Unstable angina.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Peak Oxygen Consumption (VO₂ peak) | Baseline, 12 weeks | 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. |
| Change in 6-Minute Walk Distance (6MWD) | Baseline, 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Psychological Status (Anxiety) | Baseline, 12 weeks | Assessed using the Hamilton Anxiety Scale (HAMA). A lower score indicates less anxiety. |
| Change in Psychological Status (Depression) | Baseline, 12 weeks | Assessed using the Hamilton Depression Scale (HAMD). A lower score indicates less depression. |
| Change in Quality of Life | Baseline, 12 weeks | Measured using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), which assesses eight domains of health. |
| Change in Cardiac Index (CI) | Baseline, 12 weeks | Assessed non-invasively to measure cardiac output relative to body surface area. |
| Change in Left Ventricular Ejection Fraction (LVEF) | Baseline, 12 weeks | Assessed as a percentage (%) by transthoracic echocardiography. |
| Incidence of Major Adverse Events | Up to 12 weeks | Number of participants experiencing major adverse cardiovascular events (e.g., death, myocardial infarction, urgent revascularization). |
| Change in Stroke Volume Index (SVI) | Baseline, 12 weeks | Assessed non-invasively to measure the volume of blood pumped from the ventricle per beat relative to body surface area. |
| Change in Systemic Vascular Resistance Index (SVRI) | Baseline, 12 weeks | Assessed non-invasively to measure the resistance to blood flow offered by all systemic vasculature, indexed to body surface area. |
| Adherence to Rehabilitation Program | Up to 12 weeks | Calculated as the percentage of completed sessions out of the 36 total prescribed sessions for the HBTCR and CBCR groups. |
| Change in Forced Expiratory Volume in 1 second to Forced Vital Capacity Ratio (FEV1/FVC) | Baseline, 12 weeks | Measured by spirometry to assess pulmonary function. |
Countries
China
Outcome results
None listed