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  • A pilot randomised controlled trial of a structured, home-based exercise programme on cardiovascular structure and function in kidney transplant recipients: the ECSERT study design and methods

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Renal medicine
Protocol
A pilot randomised controlled trial of a structured, home-based exercise programme on cardiovascular structure and function in kidney transplant recipients: the ECSERT study design and methods
  1. Roseanne E Billany1,2,
  2. Noemi Vadaszy3,
  3. Nicolette C Bishop4,
  4. Thomas J Wilkinson3,
  5. Sherna F Adenwalla1,2,
  6. Katherine A Robinson1,
  7. Kathryn Croker2,
  8. Emer M Brady1,
  9. Joanne V Wormleighton5,
  10. Kelly S Parke1,5,
  11. Nicola J Cooper3,
  12. Angela C Webster6,7,
  13. Jonathan Barratt1,2,
  14. Gerry P McCann1,
  15. James O Burton1,2,
  16. Alice C Smith3,
  17. Matthew PM Graham-Brown1,2
  1. 1Department of Cardiovascular Sciences, University of Leicester, Leicester, UK
  2. 2John Walls Renal Unit, University Hospitals of Leicester NHS Trust, Leicester, UK
  3. 3Department of Health Sciences, University of Leicester, Leicester, UK
  4. 4School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK
  5. 5Department of Radiology, University Hospitals of Leicester NHS Trust, Leicester, UK
  6. 6School of Public Health, The University of Sydney, Sydney, New South Wales, Australia
  7. 7Centre for Renal and Transplant Research, Westmead Hospital, Westmead, New South Wales, Australia
  1. Correspondence to Dr Matthew PM Graham-Brown; mgb23{at}leicester.ac.uk

Abstract

Background Cardiovascular disease (CVD) is a major cause of morbidity and mortality in kidney transplant recipients (KTRs). CVD risk scores underestimate risk in this population as CVD is driven by clustering of traditional and non-traditional risk factors, which lead to prognostic pathological changes in cardiovascular structure and function. While exercise may mitigate CVD in this population, evidence is limited, and physical activity levels and patient activation towards exercise and self-management are low. This pilot study will assess the feasibility of delivering a structured, home-based exercise intervention in a population of KTRs at increased cardiometabolic risk and evaluate the putative effects on cardiovascular structural and functional changes, cardiorespiratory fitness, quality of life, patient activation, healthcare utilisation and engagement with the prescribed exercise programme.

Methods and analysis Fifty KTRs will be randomised 1:1 to: (1) the intervention; a 12week, home-based combined resistance and aerobic exercise intervention; or (2) the control; usual care. Intervention participants will have one introductory session for instruction and practice of the recommended exercises prior to receiving an exercise diary, dumbbells, resistance bands and access to instructional videos. The study will evaluate the feasibility of recruitment, randomisation, retention, assessment procedures and the intervention implementation. Outcomes, to be assessed prior to randomisation and postintervention, include: cardiac structure and function with stress perfusion cardiac MRI, cardiorespiratory fitness, physical function, blood biomarkers of cardiometabolic health, quality of life and patient activation. These data will be used to inform the power calculations for future definitive trials.

Ethics and dissemination The protocol was reviewed and given favourable opinion by the East Midlands-Nottingham 2 Research Ethics Committee (reference: 19/EM/0209; 14 October 2019). Results will be published in peer-reviewed academic journals and will be disseminated to the patient and public community via social media, newsletter articles and presentations at conferences.

Trial registration number NCT04123951.

  • renal transplantation
  • cardiology
  • public health
http://creativecommons.org/licenses/by-nc/4.0/

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, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

http://dx.doi.org/10.1136/bmjopen-2020-046945

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    Footnotes

    • Twitter @RBillany, @SAdenwalla

    • Contributors REB and MG-B: study design, study set-up, completion of study visits, drafting of manuscript, revision of manuscript, finalising of manuscript. NCB, TJW, ACW, SFA, KAR, KC, EMB, NJC, JB, GPM, JOB, ACS: study design, drafting of manuscript, revision of manuscript. NV, KSP, JVW: completion of study visits, drafting of manuscript, revision of manuscript.

    • Funding This study was funded by a project grant from Kidney Research UK (ref: KS_RP_003_20180913).

    • Disclaimer Neither the sponsor nor the funder had or will have any input into study design; collection, management, analysis and interpretation of data; writing of the report; or the decision to submit the report for publication. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.

    • Competing interests None declared.

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

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.