Clinical trial NCT02047942: Telerehabilitation in Coronary Heart Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
name: Hasselt University
First posted: 2014-01-28
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: exercise tolerance
timeFrame: 1 year
measure: exercise tolerance
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
Study officials:
References:
citation: Avila A, Claes J, Buys R, Azzawi M, Vanhees L, Cornelissen V. Home-based exercise with telemonitoring guidance in patients with coronary artery disease: Does it improve long-term physical fitness? Eur J Prev Cardiol. 2020 Mar;27(4):367-377. doi: 10.1177/2047487319892201. Epub 2019 Dec 1.
citation: Avila A, Claes J, Goetschalckx K, Buys R, Azzawi M, Vanhees L, Cornelissen V. Home-Based Rehabilitation With Telemonitoring Guidance for Patients With Coronary Artery Disease (Short-Term Results of the TRiCH Study): Randomized Controlled Trial. J Med Internet Res. 2018 Jun 22;20(6):e225. doi: 10.2196/jmir.9943.