Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), Myocardial Infarction, Percutaneous Transluminal Cutting Balloon Angioplasty of Popliteal Vein Using Fluoroscopic Guidance
Conditions
Brief summary
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.
Interventions
BEHAVIORALCenter-based cardiac rehabilitation
BEHAVIORALHome-based training with telemonitoring guidance
Sponsors
Jessa Hospital
Hasselt University
KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| exercise tolerance | 1 year | comparison of evolution of exercise tolerance from baseline to one-year |
Countries
Belgium
Outcome results
None listed