Comparative Effectiveness of Three Home-Based Rehabilitation Programs in Patients With Acute Coronary Syndrome: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Anaerobic Threshold
研究概览
简要总结
This study aims to compare the effectiveness of three different home-based rehabilitation programs for patients with acute coronary syndrome (ACS). This randomized controlled trial will recruit 60 ACS patients, divided into three groups: a 12-week home rehabilitation group, a 6-week tele-rehabilitation followed by 6-week home rehabilitation group, and a 12-week tele-rehabilitation combined with home rehabilitation group. Patients will be assessed at baseline, and at 3, 6, and 12 months on physical health, cardiopulmonary function, and psychological well-being. The hypothesis is that home-based CR, particularly with tele-rehabilitation, will improve recovery and quality of life more effectively. The study aims to identify the most beneficial home rehabilitation strategy for ACS patients.
详细描述
This study is designed to evaluate the benefits of three different home-based cardiac rehabilitation (CR) models on the recovery of patients with acute coronary syndrome (ACS). Cardiovascular diseases are a major cause of mortality worldwide, but advancements in CR have significantly improved patient outcomes. Despite the proven benefits of CR in enhancing quality of life and reducing hospital readmission rates, participation in traditional CR programs remains low. Home-based CR, especially using tele-rehabilitation technologies, offers a promising alternative. This randomized controlled trial will recruit 60 ACS patients, divided into three groups: a 12-week home rehabilitation group, a 6-week tele-rehabilitation followed by a 6-week home rehabilitation group, and a 12-week tele-rehabilitation combined with home rehabilitation group. All patients will undergo evaluations at baseline, and at 3, 6, and 12 months to assess physical health, cardiopulmonary function, and psychological well-being. The hypothesis is that home-based CR, particularly with tele-rehabilitation support, will enhance recovery and quality of life more effectively than traditional methods. The findings aim to identify the most effective home rehabilitation strategy for ACS patients, providing insights into improving their cardiopulmonary function and overall well-being.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized for acute coronary syndrome (ACS) and have undergone percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) surgery.
- •Aged 18 years or older.
- •Regular adherence to prescribed medication regimen.
- •Stable medical condition and vital signs.
- •Conscious and able to follow instructions.
- •Able to provide informed consent.
排除标准
- •Unable to comply with rehabilitation or assessment procedures.
- •Inability to walk independently.
- •Dependent in daily living activities prior to hospitalization (Barthel Index score less than 80).
- •Terminal illness with an expected life span of less than one year. Contraindications to cardiac rehabilitation as per the American College of Sports Medicine guidelines, such as unstable angina, uncontrolled severe hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg), postural hypotension (blood pressure drop of more than 20 mmHg upon standing), severe aortic stenosis, uncontrolled severe arrhythmias, decompensated heart failure, third-degree atrioventricular block, acute pericarditis or myocarditis, aortic dissection, acute pulmonary embolism, and other acute medical conditions like infections and fever.
结局指标
主要结局
Anaerobic Threshold
时间窗: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
This measure will evaluate cardiopulmonary function by assessing the anaerobic threshold. The anaerobic threshold is the exercise intensity at which lactate begins to accumulate in the blood, indicating the transition from aerobic to anaerobic metabolism.
Oxygen Pulse
时间窗: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
This measure will evaluate cardiopulmonary function by assessing the oxygen pulse, which is the amount of oxygen used by the body per heartbeat during exercise. It provides insights into cardiovascular efficiency and respiratory function.
Maximal Oxygen Uptake (VO2 max)
时间窗: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
his measure will evaluate cardiopulmonary function by assessing the maximal oxygen uptake (VO2 max). VO2 max is the maximum amount of oxygen the body can utilize during intense exercise and is an indicator of cardiovascular and respiratory efficiency.
次要结局
- Muscle strength(Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.)
- Sit-to-Stand Test(Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.)
- Six-Minute Walk Test (6MWT)(Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.)