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

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posted on 27.10.2021, 10:27 by Roseanne Billany, Noemi Vadaszy, Nicolette BishopNicolette Bishop, Thomas Wilkinson, Sherna Adenwalla, Katherine Robinson, Kathryn Croker, Emer Brady, Joanne Wormleighton, Kelly Parke, Nicola Cooper, Angela Webster, Jonathan Barratt, Gerry McCann, James Burton, Alice Smith, Matthew Graham-Brown
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. Whilst 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 program.
Methods and analysis: Fifty KTRs will be randomised 1:1 to: (1) the intervention; a 12-week 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 post-intervention, include: cardiac structure and function with stress-perfusion cardiac magnetic resonance imaging, 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 (ref 19/EM/0209; 14/10/2019). 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; prospectively registered.

Funding

Kidney Research UK (ref: KS_RP_003_20180913)

History

School

  • Sport, Exercise and Health Sciences

Published in

BMJ Open

Volume

11

Publisher

BMJ Publishing Group

Version

VoR (Version of Record)

Rights holder

© The Authors

Publisher statement

This is an Open Access Article. It is published by BMJ Publishing Group under the Creative Commons Attribution-NonCommercial 4.0 International Licence (CC BY-NC 4.0). Full details of this licence are available at: https://creativecommons.org/licenses/by-nc/4.0/

Acceptance date

16/08/2021

Publication date

2021-10-05

Copyright date

2021

ISSN

2044-6055

eISSN

2044-6055

Language

en

Depositor

Prof Lettie Bishop. Deposit date: 6 September 2021

Article number

e046945