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The EX-FRAIL CKD trial: A study protocol for a pilot randomised controlled trial of a home-based EXercise programme for pre-frail and FRAIL, older adults with Chronic Kidney Disease

Nixon, AC, Bampouras, TM, Gooch, HJ, Young, HML, Finlayson, KW, Pendleton, N, Mitra, S, Brady, ME and Dhaygude, AP (2020) The EX-FRAIL CKD trial: A study protocol for a pilot randomised controlled trial of a home-based EXercise programme for pre-frail and FRAIL, older adults with Chronic Kidney Disease. BMJ Open, 10 (6). ISSN 2044-6055

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Open Access URL: http://doi.org/10.1136/bmjopen-2019-035344 (Published version)


Introduction Frailty is highly prevalent in adults with chronic kidney disease (CKD) and is associated with adverse health outcomes including falls, poorer health-related quality of life (HRQOL), hospitalisation and mortality. Low physical activity and muscle wasting are important contributors to physical frailty in adults with CKD. Exercise training may improve physical function and frailty status leading to associated improvements in health outcomes, including HRQOL. The EX-FRAIL CKD trial aims to inform the design of a definitive randomised controlled trial (RCT) that investigates the effectiveness of a progressive, multicomponent home-based exercise programme in prefrail and frail older adults with CKD. Methods and analysis The EX-FRAIL CKD trial is a two-arm parallel group pilot RCT. Participants categorised as prefrail or frail, following Frailty Phenotype (FP) assessment, will be randomised to receive exercise or usual care. Participants randomised to the intervention arm will receive a tailored 12-week exercise programme, which includes weekly telephone calls to advise on exercise progression. Primary feasibility outcome measures include rate of recruitment, intervention adherence, outcome measure completion and participant attrition. Semistructured interviews with a purposively selected group of participants will inform the feasibility of the randomisation procedures, outcome measures and intervention. Secondary outcome measures include physical function (walking speed and Short Physical Performance Battery), frailty status (FP), fall concern (Falls Efficacy Scale-International tool), activities of daily living (Barthel Index), symptom burden (Palliative care Outcome Scale-Symptoms RENAL) and HRQOL (Short Form-12v2). Ethics and dissemination Ethical approval was granted by a National Health Service (NHS) Regional Ethics Committee and the NHS Health Research Authority. The study team aims to publish findings in a peer-reviewed journal and presents the results at relevant national and international conferences. A summary of findings will be provided to participants, a local kidney patient charity and the funding body. Trial registration number ISRCTN87708989.

Item Type: Article
Uncontrolled Keywords: Humans; Exercise Therapy; Pilot Projects; Aged; Aged, 80 and over; Frail Elderly; Renal Insufficiency, Chronic; Randomized Controlled Trials as Topic; adult nephrology; chronic renal failure; end stage renal failure; geriatric medicine; Aged; Aged, 80 and over; Exercise Therapy; Frail Elderly; Humans; Pilot Projects; Randomized Controlled Trials as Topic; Renal Insufficiency, Chronic; 1103 Clinical Sciences; 1117 Public Health and Health Services; 1199 Other Medical and Health Sciences
Subjects: R Medicine > RA Public aspects of medicine > RA0421 Public health. Hygiene. Preventive Medicine
R Medicine > RC Internal medicine > RC1200 Sports Medicine
G Geography. Anthropology. Recreation > GV Recreation Leisure > GV561 Sports
Divisions: Sport & Exercise Sciences
Publisher: BMJ
SWORD Depositor: A Symplectic
Date Deposited: 01 Feb 2023 12:41
Last Modified: 01 Feb 2023 12:41
DOI or ID number: 10.1136/bmjopen-2019-035344
URI: https://researchonline.ljmu.ac.uk/id/eprint/18780
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