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

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    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.

    Original languageEnglish
    Article numbere019748
    JournalBMJ
    Volume8
    Issue number3
    DOIs
    Publication statusPublished - 23 Mar 2018

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    Exercise Therapy
    Sternotomy
    Cost-Benefit Analysis
    Randomized Controlled Trials
    Exercise
    Cardiac Rehabilitation
    Guidelines
    Muscular Atrophy
    Thoracic Surgery
    Inpatients

    Bibliographical note

    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/

    Keywords

    • Journal Article
    • Research Support
    • Non US Government

    Cite this

    Early initiation of post-sternotomy cardiac rehabilitation exercise training (SCAR) : study protocol for a randomised controlled trial and economic evaluation. / Ennis, Stuart; Lobley, Grace; Worrall, Sandra; Powell, Richard; Kimani, Peter K; Khan, Amir Jahan; Banerjee, Prithwish; Barker, Thomas; McGregor, Gordon.

    In: BMJ, Vol. 8, No. 3, e019748, 23.03.2018.

    Research output: Contribution to journalArticle

    Ennis, Stuart ; Lobley, Grace ; Worrall, Sandra ; Powell, Richard ; Kimani, Peter K ; Khan, Amir Jahan ; Banerjee, Prithwish ; Barker, Thomas ; McGregor, Gordon. / Early initiation of post-sternotomy cardiac rehabilitation exercise training (SCAR) : study protocol for a randomised controlled trial and economic evaluation. In: BMJ. 2018 ; Vol. 8, No. 3.
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    T2 - study protocol for a randomised controlled trial and economic evaluation

    AU - Ennis, Stuart

    AU - Lobley, Grace

    AU - Worrall, Sandra

    AU - Powell, Richard

    AU - Kimani, Peter K

    AU - Khan, Amir Jahan

    AU - Banerjee, Prithwish

    AU - Barker, Thomas

    AU - McGregor, Gordon

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    N2 - 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.

    AB - 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.

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    KW - Research Support

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    DO - 10.1136/bmjopen-2017-019748

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