Objective The evidence for cardiac rehabilitation after valve surgery remains sparse. Current recommendations are therefore based on patients with ischaemic heart disease. The aim of this randomised clinical trial was to assess the effects of cardiac rehabilitation versus usual care after heart valve surgery.
Methods The trial was an investigator-initiated, randomised superiority trial (The CopenHeartVR trial, VR; valve replacement or repair). We randomised 147 patients after heart valve surgery 1:1 to 12 weeks of cardiac rehabilitation consisting of physical exercise and monthly psycho-educational consultations (intervention) versus usual care without structured physical exercise or psycho-educational consultations (control). Primary outcome was physical capacity measured by VO2 peak and secondary outcome was self-reported mental health measured by Short Form-36.
Results 76% were men, mean age 62 years, with aortic (62%), mitral (36%) or tricuspid/pulmonary valve surgery (2%). Cardiac rehabilitation compared with control had a beneficial effect on VO2 peak at 4 months (24.8 mL/kg/min vs 22.5 mL/kg/min, p=0.045) but did not affect Short Form-36 Mental Component Scale at 6 months (53.7 vs 55.2 points, p=0.40) or the exploratory physical and mental outcomes. Cardiac rehabilitation increased the occurrence of self-reported non-serious adverse events (11/72 vs 3/75, p=0.02).
Conclusions Cardiac rehabilitation after heart valve surgery significantly improves VO2 peak at 4 months but has no effect on mental health and other measures of exercise capacity and self-reported outcomes. Further research is needed to justify cardiac rehabilitation in this patient group.
Trial registration number NCT01558765, Results.
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Contributors A-DZ, SKB, KLS, LK, CH, CG, JL and JPS designed the trial and developed the protocol. KLS in collaboration with A-DZ and SKB drafted the manuscript. SSR and TBR contributed significantly during this process. LCT, RST and KLS designed and drafted the statistical analysis plan, LCT performed the statistical analyses for the primary and secondary outcomes, KLS performed all other statistical analyses. LT in collaboration wih A-DZ, SKB and KLS designed the physical exercise intervention. TBH and PPJ contributed significantly during data collection. KLS, SKB, TBH, TBR, SSR, LT, PPJ, CH, LK, CG, LCT, JL, JPS, RST and A-DZ all revised the manuscript critically. All authors have given their final approval of the version to be published.
Funding The Danish Strategic Research Foundation (10-092790); The Heart Centre Research Council, Rigshospitalet; Familien Hede Nielsen Foundation (2013-1226); The National Institute of Public Health, University of Southern Denmark; and Region Zealand Health Research Foundation, Denmark (12-000095/jun2014). The funders had no influence on the trial design, the execution of the trial or the interpretation of data.
Competing interests None declared.
Patient consent Obtained.
Ethics approval The Danish Ethics Committee (protocol no: H-1-2011-157) and The Danish Data Protection Agency (j. no 2007-58-0015).
Provenance and peer review Not commissioned; externally peer reviewed.