Title
Effect of comprehensive cardiac rehabilitation after heart valve surgery (<tex>$CopenHeart_{VR}$</tex>)): study protocol for a randomised clinical trialEffect of comprehensive cardiac rehabilitation after heart valve surgery (<tex>$CopenHeart_{VR}$</tex>)): study protocol for a randomised clinical trial
Author
Faculty/Department
Faculty of Medicine and Health Sciences
Research group
Translational Pathophysiological Research (TPR)
Publication type
article
Publication
Subject
Human medicine
Source (journal)
Trials
Volume/pages
14(2013), p. 1-14
ISSN
1745-6215
1745-6215
Article Reference
104
Carrier
E-only publicatie
Target language
English (eng)
Full text (Publishers DOI)
Affiliation
University of Antwerp
Abstract
Background: Heart valve diseases are common with an estimated prevalence of 2.5% in the Western world. The number is rising due to an ageing population. Once symptomatic, heart valve diseases are potentially lethal, and heavily influence daily living and quality of life. Surgical treatment, either valve replacement or repair, remains the treatment of choice. However, post surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesise that a comprehensive cardiac rehabilitation programme can improve physical capacity and self-assessed mental health and reduce hospitalisation and healthcare costs after heart valve surgery. Methods: A randomised clinical trial, CopenHeart(VR), aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 210 patients, 1:1 intervention to control group, using central randomisation, and blinded outcome assessment and statistical analyses. The intervention consists of 12 weeks of physical exercise, and a psycho-educational intervention comprising five consultations. Primary outcome is peak oxygen uptake (VO2 peak) measured by cardiopulmonary exercise testing with ventilatory gas analysis. Secondary outcome is self-assessed mental health measured by the standardised questionnaire Short Form 36. Also, long-term healthcare utilisation and mortality as well as biochemistry, echocardiography and cost-benefit will be assessed. A mixed-method design is used to evaluate qualitative and quantitative findings encompassing a survey-based study before the trial and a qualitative pre- and post-intervention study. Discussion: The study is approved by the local regional Research Ethics Committee (H-1-2011-157), and the Danish Data Protection Agency (j.nr. 2007-58-0015).
Full text (open access)
https://repository.uantwerpen.be/docman/irua/92bfeb/4079.pdf
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