Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 870
- 试验地点
- 2
- 主要终点
- Time to composite of total mortality, and hospitalization for heart failure and atherothrombotic disease (including non-fatal MI, unstable angina and stroke).
研究概览
简要总结
An intervention study with longitudinal follow-up of patients with coronary artery disease undergoing early cardiac rehabilitation is designed.
详细描述
The main objective of the study is to investigate patient-reported outcomes, their relation to clinical characteristics of the patients and the potential to predict health outcomes and adverse events in coronary artery disease patients participating in an early cardiac rehabilitation programme.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Diagnosis of coronary artery disease
- •>=18 years of age
- •Has performed a negative exercise test (bike or treadmill) and thereby able to participate in exercise training.
排除标准
- •Cognitive impairment
- •Unstable angina pectoris
- •Aortic stenosis
- •Left ventricular ejection fraction <30%
- •Heart failure NYHA class III-IV
- •Serious arrhythmia in need of treatment
- •Being on the waiting list for percutaneous coronary intervention or coronary artery bypass grafting.
研究组 & 干预措施
Early cardiac rehabilitation
Single Group: 5 week cardiac rehabilitation programme. Pre-post comparison.
干预措施: Early cardiac rehabilitation (Other)
结局指标
主要结局
Time to composite of total mortality, and hospitalization for heart failure and atherothrombotic disease (including non-fatal MI, unstable angina and stroke).
时间窗: Up to 10 years
Time to combined endpoint from inclusion.
次要结局
- Change in Self-reported health(Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks)
- Change in self-reported global health(Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks)
- Nicotine dependence(Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks)
- Change in physical and mental dimensions of health(Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks)
- Change in health status following myocardial infarction(Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks)
- Change in post traumatic growth(Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks)
- Change in anxiety and depression(Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks)