title: Effect of comprehensive cardiac rehabilitation after heart valve surgery (CopenHeartVR): study protocol for a randomised clinical trial.
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, 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.
  
  
  CONCLUSIONS
  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).
  
  
  BACKGROUND
  ClinicalTrials.gov (http://NCT01558765).
authors.affiliation: The Heart Centre, Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. kirstine.laerum.sibilitz@rh.regionh.dk
authors.forename: Kirstine Laerum
authors.initials: KL
authors.lastname: Sibilitz
authors.forename: Selina Kikkenborg
authors.initials: SK
authors.lastname: Berg
authors.forename: Tina Birgitte
authors.initials: TB
authors.lastname: Hansen
authors.forename: Signe Stelling
authors.initials: SS
authors.lastname: Risom
authors.forename: Trine Bernholdt
authors.initials: TB
authors.lastname: Rasmussen
authors.forename: Christian
authors.initials: C
authors.lastname: Hassager
authors.forename: Lars
authors.initials: L
authors.lastname: Køber
authors.forename: Daniel
authors.initials: D
authors.lastname: Steinbrüchel
authors.forename: Christian
authors.initials: C
authors.lastname: Gluud
authors.forename: Per
authors.initials: P
authors.lastname: Winkel
authors.forename: Lau Caspar
authors.initials: LC
authors.lastname: Thygesen
authors.forename: Jane Lindschou
authors.initials: JL
authors.lastname: Hansen
authors.forename: Jean Paul
authors.initials: JP
authors.lastname: Schmid
authors.forename: Viviane
authors.initials: V
authors.lastname: Conraads
authors.forename: Barbara Christina
authors.initials: BC
authors.lastname: Brocki
authors.forename: Ann-Dorthe
authors.initials: AD
authors.lastname: Zwisler
mesh_terms: D006348:Cardiac Surgical Procedures / Q000009:adverse effects / Q000191:economics / Q000401:mortality / Q000523:psychology / Q000534:rehabilitation*; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D003362:Cost-Benefit Analysis; D003718:Denmark; D005080:Exercise Test; D005081:Exercise Therapy / Q000191:economics; D017048:Health Care Costs; D007722:Health Knowledge, Attitudes, Practice; D006349:Heart Valve Diseases / Q000191:economics / Q000401:mortality / Q000503:physiopathology / Q000523:psychology / Q000534:rehabilitation* / Q000601:surgery*; D006801:Humans; D008603:Mental Health; D010101:Oxygen Consumption; D010353:Patient Education as Topic / Q000191:economics; D011182:Postoperative Care; D020127:Recovery of Function; D012017:Referral and Consultation / Q000191:economics; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome