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临床试验/NCT02047942
NCT02047942已完成不适用

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

KU Leuven2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2014年2月最近更新:
适应症
干预措施

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

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

Active Comparator

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

Experimental

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

No Intervention

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

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Véronique Cornelissen

Dr

KU Leuven

研究点 (2)

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