Abstract
BackgroundHeart 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.MethodsA randomised clinical trial, CopenHeartVR, 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.DiscussionThe 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).Trial registrationClinicalTrials.gov (http://NCT01558765).
Highlights
Heart valve diseases are common with an estimated prevalence of 2.5% in the Western world
Clinical guidelines emphasise the importance of specialised rehabilitation after valvular surgery [7], randomised clinical trials on rehabilitation after heart valve surgery are few in number
Major parts of the methods section and trial design in this paper are similar to two other randomised clinical trials, CopenHeartRFA and CopenHeartIE, and sections from this paper will be identical in these trial protocols [23,24]
Summary
Heart valve diseases are common with an estimated prevalence of 2.5% in the Western world population [1]. Clinical guidelines emphasise the importance of specialised rehabilitation after valvular surgery [7], randomised clinical trials on rehabilitation after heart valve surgery are few in number. Current guidelines on cardiac rehabilitation in valvular heart disease are based primarily on results from randomised clinical trials on cardiac rehabilitation in patients with coronary artery disease [8] and congestive heart failure [9]. It is questionable whether the results from these trials are transferable to a heart valve surgery population. Marital status Height, weight, body mass index Medical history History of heart disease Diabetes mellitus Kidney diseasea Chronic obstructive pulmonary disease (COPD)b Hypertension Dyslipidemiac Medicine Use of medication, self-reported Heart valve specific questions Type of heart valve disease Type of heart valve surgery NYHA classification Left ventricle ejection fraction (LVEF)d Euro SCORE IIe Postsurgical complications Postsurgical arrhythmiasf Pacemaker post surgery Clinical measurements Biochemical screening ECG Echocardiography Physical testing Six minute walk test Cardiopulmonary Exercise Testing Sit and stand test Questionnaires Level of education Employment status Smoking SF-36g HADS QoL-CV EQ-5Dg HeartQoL IPAQ Physical activity score Emotion and Health Scale Rehabilitation receivedh
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