Methods: A multicentre, randomised clinical trial including adults with left-sided or cardiac device endocarditis. Participants were randomised 1:1 to CCR consisting of 5 psycho-educational consultations and 12 weeks of exercise training plus usual care, or to usual care alone. Primary outcome was mental health by the Mental Component Score (MCS) on the SF-36 questionnaire at 6 months, secondary outcome was peak oxygen uptake (peak VO2) by ergo-spirometry testing at 4 months. A blinded statistician conducted all analysis using a mixed linear model and intention-to-treat analyses. Exploratory outcomes including fatigue, anxiety, depression, and additional physical tests were investigated.
Results: From 2011 to 2016, 117 patients were included. Mean age was 60 (SD=13.6) and 81% were male. No interaction between intervention and time was found for MCS (p=0.41) or peak VO2 (p=0.09). A significant effect favouring CR was seen in the exploratory outcomes general fatigue (p=0.005) and maximal power (watt) (p=0.005).
Conclusions: The provided CCR following IE had no significant effect on the primary or secondary outcomes. CCR content, duration, statistical power or lack of adherence may have influenced results. The study calls for further investigation before implementing CR on a larger scale in this high need population.