Early initiation of post-sternotomy cardiac rehabilitation exercise training (SCAR): study protocol for a randomised controlled trial and economic evaluation

Stuart Ennis, Grace Lobley, Sandra Worrall, Richard Powell, Peter K Kimani, Amir Jahan Khan, Prithwish Banerjee, Thomas Barker, Gordon McGregor, Stuart Ennis, Grace Lobley, Sandra Worrall, Richard Powell, Peter K Kimani, Amir Jahan Khan, Prithwish Banerjee, Thomas Barker, Gordon McGregor

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.

Keywords: cardiovascular fitness; coronary artery bypass graft; coronary heart disease; muscle atrophy; valve replacement.

Conflict of interest statement

Competing interests: None declared.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
Trial flow chart—University Hospitals Coventry and Warwickshire. *Assessment to include: 6 min walk, five times sit-to-stand, grip strength, isometric leg strength, Generalised Anxiety Disorder assessment, Patient Health Questionnaire, 12-Item Short Form Survey, 5-Item EuroQol, Client Service Receipt Inventory. CR, cardiac rehabilitation.

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