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

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Author
Ennis, Stuart
Lobley, Grace
Worrall, Sandra
Powell, Richard
Kimani, Peter
Khan, Amir Jahan
Banerjee, Prithwish
Barker, Thomas
McGregor, Gordon
Date
2018-03-23Acceptance date
2018-02-23
Type
Article
Publisher
BMJ Publishing Group
ISSN
2044-6055
Metadata
Show full item recordAbstract
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.
Journal/conference proceeding
BMJ Open;
Citation
Ennis, S., Lobley, G., Worrall, S., Powell, R., Kimani, P.K., Khan, A.J., Banerjee, P., Barker, T. and McGregor, G. (2018) 'Early initiation of post-sternotomy cardiac rehabilitation exercise training (SCAR): study protocol for a randomised controlled trial and economic evaluation', BMJ Open, 8(3), p.e019748. DOI: 10.1136/bmjopen-2017-019748.
Description
Article published in BMJ Open on 23 March 2018, available open access at: http://dx.doi.org/10.1136/bmjopen-2017-019748.
Sponsorship
Cardiff Metropolitan University (Grant ID: Cardiff Metropolian (Internal))
This work was supported by the Jeremy Pilcher Memorial Fund (UHCW), the Medical & Life Sciences Research Fund and Atrium Health Ltd, Coventry
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