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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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posted on 12.10.2021, 12:19 by Roseanne Billany, Noemi Vadaszy, Nicolette C Bishop, Thomas J Wilkinson, Sherna F Adenwalla, Katherine A Robinson, Kathryn Croker, Emer M Brady, Joanne Wormleighton, Kelly Parke, Nicola J Cooper, Angela Webster, Jonathan Barratt, Gerry McCann, James Burton, Alice C 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. 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.

History

Citation

BMJ Open 2021;11:e046945. doi: 10.1136/bmjopen-2020-046945

Author affiliation

Department of Health Sciences, University of Leicester

Version

VoR (Version of Record)

Published in

BMJ Open

Volume

11

Publisher

BMJ Journals

issn

2044-6055

Copyright date

2021

Available date

12/10/2021

Language

en

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