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.

Autor:	Nixon AC; Department of Renal Medicine, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, Lancashire, UK andrew.nixon3@nhs.net.; Division of Cardiovascular Sciences, The University of Manchester, Manchester, UK.; Centre for Health Research and Innovation, NIHR Lancashire Clinical Research Facility, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, Lancashire, UK., Bampouras TM; Lancaster Medical School, Lancaster University, Lancaster, Lancashire, UK.; The Centre for Ageing Research, Lancaster University, Lancaster, Lancashire, UK., Gooch HJ; Centre for Health Research and Innovation, NIHR Lancashire Clinical Research Facility, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, Lancashire, UK.; Core Therapies Department, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, Lancashire, UK., Young HML; Department of Respiratory Sciences, University of Leicester, Leicester, UK.; John Walls Renal Unit, University Hospitals of Leicester NHS Trust, Leicester, UK., Finlayson KW; Research in Childbirth and Health Unit, University of Central Lancashire, Preston, Lancashire, UK., Pendleton N; Division of Neuroscience and Experimental Psychology, The University of Manchester, Manchester, UK., Mitra S; Manchester Academic Health Sciences Centre, The University of Manchester, Manchester, UK.; Devices for Dignity, NIHR MedTech & In-vitro Diagnostics Co-operative, Sheffield, UK., Brady ME; Department of Renal Medicine, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, Lancashire, UK., Dhaygude AP; Department of Renal Medicine, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, Lancashire, UK.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2020 Jun 22; Vol. 10 (6), pp. e035344. Date of Electronic Publication: 2020 Jun 22.
DOI:	10.1136/bmjopen-2019-035344
Abstrakt:	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. Competing Interests: Competing interests: Unrelated to this body of work, APD has received lecture fees from speaking at the invitation of MSD and received travel support from Pharmacosmos. (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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