Efficacy of Home-Based Telerehabilitation Versus Center-Based Cardiac Rehabilitation on Cardiopulmonary Function and Exercise Capacity in Patients After Coronary Artery Bypass Grafting: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change in Peak Oxygen Consumption (VO₂ peak)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Home-Based Telerehabilitation (HBTCR) Group
Participants received a personalized 12-week cardiac rehabilitation program to perform at home. They were provided with a wearable heart rate monitor and used a mobile application to log their exercise sessions and vital signs. A rehabilitation team remotely monitored their progress and communicated weekly via phone or video call.
干预措施: Structured Exercise Program (Behavioral)
Center-Based Cardiac Rehabilitation (CBCR) Group
Participants attended supervised cardiac rehabilitation sessions at the hospital's rehabilitation center three times per week for 12 weeks. Each session included warm-up, aerobic exercise, resistance training, and cool-down under the direct supervision of a healthcare team.
干预措施: Structured Exercise Program (Behavioral)
Control Group
Participants received usual care, which included routine follow-up appointments and standard health education delivered through verbal instructions and printed pamphlets. They did not participate in a structured or monitored exercise program.
干预措施: Standard Health Education (Behavioral)
结局指标
主要结局
Change in Peak Oxygen Consumption (VO₂ peak)
时间窗: 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)
时间窗: 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.
次要结局
- Change in Psychological Status (Anxiety)(Baseline, 12 weeks)
- Change in Psychological Status (Depression)(Baseline, 12 weeks)
- Change in Quality of Life(Baseline, 12 weeks)
- Change in Cardiac Index (CI)(Baseline, 12 weeks)
- Change in Left Ventricular Ejection Fraction (LVEF)(Baseline, 12 weeks)
- Change in Forced Expiratory Volume in 1 second to Forced Vital Capacity Ratio (FEV1/FVC)(Baseline, 12 weeks)
- Adherence to Rehabilitation Program(Up to 12 weeks)
- Incidence of Major Adverse Events(Up to 12 weeks)
- Change in Stroke Volume Index (SVI)(Baseline, 12 weeks)
- Change in Systemic Vascular Resistance Index (SVRI)(Baseline, 12 weeks)
研究者
Yan Liu
Principal investigator
The First Hospital of Hebei Medical University