Rationale and design of randomized controlled trial protocol of cardiovascular rehabilitation based on the use of telemedicine technology in the Czech Republic (CR-GPS)

BACKGROUND: Cardiovascular diseases remain the most common causes of death in the world. Instructions for secondary prevention recommend multifaceted approach in cardiovascular diseases risk management. Center-based physical exercise training is considered as an important integral part of cardiac rehabilitation (CR). Despite all recognized benefits CR brings, active interest of patients remains low in many countries, including the Czech Republic. That is why there is a need to focus on more effective patients’ participation in CR with respect to their preferences and needs. One of possible approaches is using telemonitoring guidance based on obtaining data via technological equipment during home exercise training. The aim of this study is to compare effectiveness of both center- and home-based exercise training with focus on participants’ physical fitness and quality of life. METHODS/DESIGN: This randomized control trial intends to monitor cardiorespiratory health indicators and quality of life of patients diagnosed with a coronary artery disease (CAD) at the University Hospital Brno, Czech Republic. These patients will be randomly separated into 2 groups—a regular outpatient group (ROT) and an intervention training group (ITG). Both groups undergo a 12-week rehabilitation training program. The ROT group will undergo center-based exercise trainings in the hospital and receive feedback and support directly by their coach. The ITG group will be telemonitored during exercise training in their home environment via a wrist sport tester and Internet application. All patients will be supposed to exercise at 70% to 80% of their heart rate reserve obtained from cardiopulmonary exercise test (CPX). The primary outcome is to measure and compare physical fitness values assessed at baseline and after 12 weeks of training. Physical fitness is expressed as peak oxygen uptake assessed by the CPX test. The secondary outcomes are patients, training adherence, and their quality of life. DISCUSSION: This trial focuses on an up-to-date topic. As there have not been any similar trials in the Czech Republic yet, we expect it to bring great benefits not only for our hospital in Brno. In the long term, this method seems to be low-cost for all participants and brings a lot of benefits for those patients, who are for many reasons unable to participate in center-based CR provided by hospitals and other health care centers. Physical exercise therapy brings good results in reducing cardiovascular risk factors and improves its global impact. Thanks to its simplicity, it is expected to increase patients’ training adherence as well.