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Cardiac rehabilitation increases physical capacity but not mental health after heart valve surgery: a randomised clinical trial
  1. Kirstine L Sibilitz1,2,
  2. Selina K Berg1,3,
  3. Trine B Rasmussen1,3,
  4. Signe Stelling Risom1,4,
  5. Lau C Thygesen2,
  6. Lars Tang1,5,6,
  7. Tina B Hansen1,7,
  8. Pernille Palm Johansen1,8,
  9. Christian Gluud9,
  10. Jane Lindschou9,
  11. Jean Paul Schmid10,
  12. Christian Hassager1,
  13. Lars Køber1,
  14. Rod S Taylor2,11,
  15. Ann-Dorthe Zwisler1,2,12,13
  1. 1Department of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
  2. 2National Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark
  3. 3Department of Cardiology, Gentofte Hospital, Gentofte, Denmark
  4. 4Bachelor's Degree Programme in Nursing, Metropolitan University College, Copenhagen, Denmark
  5. 5Faculty of Health and Technology, Bachelor's Degree Programme in Physiotherapy, Department of Rehabilitation and Nutrition, Metropolitan University College, Copenhagen, Denmark
  6. 6CopenRehab, Section of Social Medicine, Department of Public Health, University of Copenhagen, Copenhagen, Denmark
  7. 7Zealand University Hospital, Department of Cardiology, Køgevej 7-13, 4000 Roskilde, Denmark
  8. 8Department of Cardiology, Bispebjerg Hospital, Copenhagen, Denmark
  9. 9Copenhagen Trial Unit, Department 7812, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
  10. 10Cardiology Clinic, Tiefenau Hospital and University of Bern, Bern, Switzerland
  11. 11Institute of Health Research, University of Exeter Medical School, Exeter, England
  12. 12Department of Cardiology, Holbaek Sygehus, Holbaek, Denmark
  13. 13National Centre of Rehabilitation and Palliation, University of Southern Denmark, and University Hospital of Odense, Odense, Denmark
  1. Correspondence to Kirstine L Sibilitz, Department of Cardiology, Rigshospitalet, Blegdamsvej 9, Copenhagen 2100, Denmark; laerum{at}gmail.com

Abstract

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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Footnotes

  • 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.

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