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Early initiation of post-sternotomy cardiac rehabilitation exercise training (SCAR): study protocol for a randomised controlled trial and economic evaluation
  1. Stuart Ennis1,2,
  2. Grace Lobley1,
  3. Sandra Worrall1,
  4. Richard Powell1,
  5. Peter K Kimani3,
  6. Amir Jahan Khan4,
  7. Prithwish Banerjee4,5,
  8. Thomas Barker6,
  9. Gordon McGregor1,4
  1. 1 Department of Cardiac Rehabilitation, Centre for Exercise and Health, University Hospital, Coventry, UK
  2. 2 Cardiff Centre for Exercise and Health, Cardiff Metropolitan University, Cardiff, UK
  3. 3 Statistics and Epidemiology, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK
  4. 4 Health and Life Sciences Research Centre, Coventry University, Coventry, UK
  5. 5 Department of Cardiology, University Hospitals, Coventry, UK
  6. 6 Department of Cardiothoracic Surgery, University Hospital, Coventry, UK
  1. Correspondence to Dr Gordon McGregor; gordon.mcgregor{at}uhcw.nhs.uk

Abstract

Introduction Current guidelines recommend abstinence from supervised cardiac rehabilitation (CR) exercise training for 6 weeks post-sternotomy. This practice is not based on empirical evidence, thus imposing potentially unnecessary activity restrictions. Delayed participation in CR exercise training promotes muscle atrophy, reduces cardiovascular fitness and prolongs recovery. Limited data suggest no detrimental effect of beginning CR exercise training as early as 2 weeks post-surgery, but randomised controlled trials are yet to confirm this. The purpose of this trial is to compare CR exercise training commenced early (2 weeks post-surgery) with current usual care (6 weeks post-surgery) with a view to informing future CR guidelines for patients recovering from sternotomy.

Methods and analysis In this assessor-blind randomised controlled trial, 140 cardiac surgery patients, recovering from sternotomy, will be assigned to 8 weeks of twice-weekly supervised CR exercise training commencing at either 2 weeks (early CR) or 6 weeks (usual care CR) post-surgery. Usual care exercise training will adhere to current UK recommendations. Participants in the early CR group will undertake a highly individualised 2–3 week programme of functional mobility, strength and cardiovascular exercise before progressing to a usual care CR programme. Outcomes will be assessed at baseline (inpatient), pre-CR (2 or 6 weeks post-surgery), post-CR (10 or 14 weeks post-surgery) and 12 months. The primary outcome will be change in 6 min walk distance. Secondary outcomes will include measures of functional fitness, quality of life and cost-effectiveness.

Ethics and dissemination Recruitment commenced on July 2017 and will complete by December 2019. Results will be disseminated via national governing bodies, scientific meetings and peer-reviewed journals.

Trial registration number NCT03223558; Pre-results.

  • coronary heart disease
  • coronary artery bypass graft
  • valve replacement
  • muscle atrophy
  • cardiovascular fitness

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors SE is the chief investigator for the trial, leading on protocol development and the research ethics application. SE, GL, SW, TB, GM, PKK, AJK, RP and PB all contributed fully to the study design. TB (cardiothoracic surgery), PKK (statistics) and AJK (health economics), provided discipline specific expertise and authored the relevant sections of the protocol and manuscript. GM prepared the manuscript which was edited by SE, TB, PKK and AJK. All authors read and approved the final version of the manuscript.

  • Funding This work was supported by the Jeremy Pilcher Memorial Fund (UHCW), the Medical & Life Sciences Research Fund and Atrium Health Ltd, Coventry.

  • Competing interests None declared.

  • Patient consent Obtained.

  • Ethics approval West Midlands—Edgbaston Research Ethics Committee (17/WM/0057).

  • Provenance and peer review Not commissioned; externally peer reviewed.

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