This study is a protocol for a pilot randomized controlled trial evaluating a virtual cardiac rehabilitation exercise program, and therefore contains no clinical results.
RCT (n=20)
Open-label
Computerized random number generator
No
Does a virtually delivered cardiac rehabilitation exercise program improve cardiopulmonary exercise capacity in patients eligible for phase IV cardiac rehabilitation?
This pilot trial protocol outlines a study to assess the feasibility and efficacy of a virtually delivered cardiac rehabilitation exercise program compared to traditional center-based rehabilitation.
BACKGROUND: Exercise-based cardiac rehabilitation is recognized as a core component of cardiovascular disease management and has been shown to reduce all-cause and cardiovascular mortality and reduce the risk of hospital readmission following a cardiac event. However, despite this, the uptake of and long-term adherence to cardiac rehabilitation exercise is poor. Delivering cardiac rehabilitation exercise virtually (ie, allowing patients to participate from their own homes) may be an alternative approach that could enhance uptake and increase adherence. OBJECTIVE: The aim of this study is to assess the feasibility of delivering a virtual cardiac rehabilitation exercise program supported by the Eastern Corridor Medical Engineering - Cardiac Rehabilitation (ECME-CR) platform. METHODS: A convenience sample (n=20) of participants eligible to participate in community-based cardiac rehabilitation exercise will be recruited. Participants will be randomized to one of two study groups. Both study groups will perform the same exercise program, consisting of twice-weekly sessions of 60 minutes each, over an 8-week intervention period. Participants in the intervention group will partake in virtually delivered cardiac rehabilitation exercise classes in their own home. The virtual exercise classes will be delivered to participants using a videoconferencing platform. Participants in the control group will attend the research center for their cardiac rehabilitation exercise classes. Intervention group participants will receive the ECME-CR digital health platform for monitoring during the class and during the intervention period. Outcomes will be assessed at baseline and following the 8-week intervention period. The primary outcome will be exercise capacity as assessed using the 6-minute walk test. Other outcome measures will include heart rate, blood pressure, weight, percentage body fat, muscle strength, and self-reported quality of life. Semistructured interviews will also be conducted with a subset of participants to explore their experiences of using the digital platform. RESULTS: Participant recruitment and data collection will begin in July 2021, and it is anticipated that the study results will be available for dissemination in spring 2022. CONCLUSIONS: This pilot trial will inform the design of a randomized controlled trial that will assess the clinical effectiveness of the ECME-CR digital health platform. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/31855.
Giggins et al. (2021) conducted an RCT in Cardiovascular disease (n=20). Virtual cardiac rehabilitation exercise program (ECME-CR platform) vs. Center-based cardiac rehabilitation was evaluated on Cardiopulmonary exercise capacity assessed using the 6-minute walk test (6MWT). This study is a protocol for a pilot randomized controlled trial evaluating a virtual cardiac rehabilitation exercise program, and therefore contains no clinical results.