Effect of comprehensive cardiac rehabilitation after heart valve surgery (CopenHeartVR): study protocol for a randomised clinical trial

摘要: Heart valve diseases are common with an estimated prevalence of 2.5% in the Western world. The number is rising due to ageing population. Once symptomatic, heart potentially lethal, and heavily influence daily living quality life. Surgical treatment, either replacement or repair, remains treatment choice. However, post surgery, transition may become a physical, mental social challenge. We hypothesise that comprehensive cardiac rehabilitation programme can improve physical capacity self-assessed health reduce hospitalisation healthcare costs after surgery. A randomised clinical trial, CopenHeartVR, aims investigate whether addition usual care superior as trial will randomly allocate 210 patients, 1:1 intervention control group, using central randomisation, blinded outcome assessment statistical analyses. consists 12 weeks exercise, psycho-educational comprising five consultations. Primary peak oxygen uptake (VO2 peak) measured by cardiopulmonary exercise testing ventilatory gas analysis. Secondary standardised questionnaire Short Form 36. Also, long-term utilisation mortality well biochemistry, echocardiography cost-benefit be assessed. mixed-method design used evaluate qualitative quantitative findings encompassing survey-based study before pre- post-intervention study. approved local regional Research Ethics Committee (H-1-2011-157), Danish Data Protection Agency (j.nr. 2007-58-0015). ClinicalTrials.gov ( http://NCT01558765 ).