Comprehensive cardiac rehabilitation for patients following infective endocarditis: results of the randomized CopenHeartIE trial.

Journal: European journal of cardiovascular nursing

Volume: 21

Issue: 3

Year of Publication: 2022

Affiliated Institutions:  The Heart Centre, Copenhagen University Hospital Rigshospitalet, Blegdamsvej , Copenhagen O , Denmark. Danish Centre for Rehabilitation and Palliative Care, Odense University Hospital, Vestergade , Nyborg , Denmark. Department of Public Health and Primary Care, University of Leuven, Kapucijnenvoer blok d, Leuven, box , B-, Belgium. National Institute of Public Health, University of Southern Denmark, Studiestræde , Copenhagen K , Denmark. Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital Rigshospitalet, Tagensvej , Copenhagen N , Denmark. Department of Heart Disease, Haukeland University Hospital, Haukelandsveien , Bergen , Norway.

Abstract summary 

Infective endocarditis is a complex and highly mortal disease requiring lengthy treatment. Physical and mental deconditioning is common. Nonetheless, rehabilitation is virtually unexplored in this population. The aim of this trial was therefore to investigate the effects of cardiac rehabilitation in patients following endocarditis.In a randomized trial, adults with left-sided or cardiac device endocarditis were randomized 1:1 to 12 weeks of physical exercise training and five psycho-educational consultations (cardiac rehabilitation) vs. usual care without rehabilitation (control). Primary outcome was mental health measured by SF-36 Mental Component Summary (MCS) at 6 months. Secondary outcome was physical capacity measured by peak oxygen uptake (VO2) at 4 months. Exploratory outcomes were investigated. Low inclusion rate resulted in trial termination before reaching the target sample size. A total of 117 participants (mean age: 60 years, 81% male) were randomized to cardiac rehabilitation (n = 58) or to control (n = 59). Mental health and physical capacity at baseline were generally poor (MCS: 38.9-42.2 points, VO2 peak: 16.1-16.6 mL/kg/min). Cardiac rehabilitation compared with control showed no effect on mental health (MCS: 44.6 points vs. 48.8 points, P = 0.41) or physical capacity (VO2 peak: 19.9 mL/kg/min vs. 18.0 mL/kg/min, P = 0.09). Effects favouring the intervention were identified in exploratory outcomes including general fatigue (P = 0.005), and physical capacity as maximal power (W) (P = 0.005). Adherence to the intervention was 28%.Results indicate no effect of cardiac rehabilitation in patients following endocarditis; however, lack of statistical power and poor adherence render findings inconclusive. Valuable insight into patients' capabilities and safety was gained, and further investigations into rehabilitation needs and modes of delivery in this high-need population should be a future priority.The trial is registered at ClinicalTrials.gov, NCT01512615.

Authors & Co-authors:  Rasmussen Trine Bernholdt TB Zwisler Ann-Dorthe AD Risom Signe Stelling SS Sibilitz Kirstine Lærum KL Christensen Jan J Bundgaard Henning H Moons Philip P Thygesen Lau Caspar LC Lindschou Jane J Norekvål Tone Merete TM Berg Selina Kikkenborg SK

Study Outcome 

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Statistics
Citations : 
Authors :  11
Identifiers
Doi : 10.1093/eurjcn/zvab047
SSN : 1873-1953
Study Population
Male,Female
Mesh Terms
Adult
Other Terms
Endocarditis;Exercise test;Mental health;Quality of life;Randomized controlled trial;Rehabilitation
Study Design
Randomized Control Trial,Case Control Trial,Exploratory Study,Cross Sectional Study
Study Approach
Country of Study
Publication Country
England