Journal of Clinical Trials
Open Access

Abstract

A Randomized Controlled Study Comparing Home-Based Training with Telemonitoring Guidance Versus Center-Based Training in Patients with Coronary Heart Disease: Rationale and Design of the Tele-Rehabilitation in Coronary Heart Disease (TRiCH) Study

Andrea Avila, Kaatje Goetschalckx, Luc Vanhees and Véronique A Cornelissen

Aerobic exercise capacity (peak VO2) and an active life style are related to long-term survival and to a reduction in cardiovascular morbidity in subjects with cardiovascular disease. However, the majority of cardiac patients do not engage enough in physical activity to obtain or maintain the benefits of a physically active lifestyle. There is a need for innovative rehabilitation methods aiming at increasing longer-term adherence and hence more sustained effects on physical fitness. One strategy might be the use of home-based training in combination with telemonitoring guidance. Here we describe the rationale, design and methods of the Tele-Rehabilitation in Coronary Heart disease study (TRiCH). The main objective of TRiCH is to compare the longer-term (=1 year) effects of a 3-month patient-tailored homebased cardiac rehabilitation program with telemonitoring guidance (Home-CR) with a supervised center-based cardiac rehabilitation program (Center-CR) in coronary artery disease patients (phase III). The study is planned as a randomized controlled prospective trial that will randomize 105 coronary artery disease patients (40-75 yrs) who have successfully completed a three month ambulatory cardiac rehabilitation program (phase II) to one of the three groups: Home-CR, Center-CR or a control group on a 1:1:1 basis. The exercise programs (frequency, intensity and time of exercise) of patients randomized to Home-CR or Center-CR will be designed according to current exercise recommendations. Patients in the control group will receive the advice to maintain a physically active lifestyle. Assessments will be performed at baseline, after 12 weeks of intervention and at one year of follow-up. The primary outcome measure is change in exercise capacity assessed by peak oxygen uptake at 3 and 12 months of follow-up. Secondary outcomes include determinants of exercise capacity, i.e. physical activity, endothelial function and muscle function, as well as
traditional cardiovascular risk factors and quality of life. It is hypothesized that home-based training with telemonitoring guidance will result in higher levels of peak VO2 at one year of follow-up. Enrollment started in February 2014; last enrollment is expected in November 2015.