A Randomized Controlled Trial Comparing Home-based Training With Telemonitoring Guidance Versus Center-based Cardiac Rehabilitation in Patients With Coronary Heart Disease: the TRiCH-study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- exercise tolerance
研究概览
简要总结
Cardiovascular diseases are the main cause of death worldwide. Aerobic fitness is related to long-term survival and a reduction in mortality and recurrent nonfatal myocardial infarction in subjects with cardiovascular disease. However, the majority of cardiac patients do not engage in enough physical activity to obtain benefits or in the long-term struggle to maintain a physically active lifestyle. There is a need for innovative rehabilitation methods aiming at increasing longer-term adherence and hence more sustained effects on health related physical fitness. One strategy might be the use of home-based training in combination of telemonitoring guidance. Therefore, the main objective of this randomized controlled clinical trial is to compare the longer-term (=1 year) effects of a 3-month supervised center-based rehabilitation program with a patient-tailored home-based cardiac rehabilitation program with telemonitoring guidance in CAD patients (phase III). The primary outcome measure is physical fitness. It is hypothesized that patients randomized to a home-based training program with telemonitoring guidance will demonstrate higher levels of physical activity at one year of follow-up, resulting in higher levels of physical fitness, compared to patients who have been enrolled to the supervised center-based cardiac rehabilitation program or control group. Ninety patients will be randomized to Home-based training, a center-based cardiac rehabilitation program or an advice only group (= control group). Assessment will be performed at baseline, immediately at completion of the intervention and at one-year of follow-up and will include measurements of exercise tolerance, cardiovascular risk factors, physical activity, muscle strength, endothelial function, health-related quality.
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
- 40 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CAD (post-PCI, post-MI, post-CABG)
- •Patients on optimal medical treatment and stable with regard to symptoms and pharmacotherapy for at least 6 weeks
- •Patients have successfully completed the 3 month ambulatory cardiac rehabilitation in hospital program
- •39 yrs < age < 76 years
- •access to internet facilities or PC at home
排除标准
- •Significant undercurrent illness last 6 weeks
- •Known severe ventricular arrhythmia with functional or prognostic significance; significant myocardial ischemia, hemodynamic deterioration or exercise-induced arrhythmia at screening or heart disease that limits exercise
- •Co-morbidity that may significantly influence one-year prognosis
- •Functional of mental disability that may limit exercise
研究组 & 干预措施
Center-based cardiac rehabilitation
Patients randomized to the center-based training group will continue their training sessions at the outpatient clinics of UZ Leuven under direct supervision of physical therapists
干预措施: Center-based cardiac rehabilitation (Behavioral)
Home-based training with telemonitoring guidance
Patients will receive an patient-tailored exercise prescription and will be asked to perform the exercise sessions in their home environment wearing heart rate monitors. Training data will be accessed by the research group on weekly basis in order to keep a record of frequency; duration and intensity of the sessions. Feedback will be given weekly to every patient.
干预措施: Home-based training with telemonitoring guidance (Behavioral)
Control
结局指标
主要结局
exercise tolerance
时间窗: 12 weeks
comparison of evolution of exercise tolerance from baseline to 12 weeks
次要结局
未报告次要终点
