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

Abstract

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, multi-component home-based exercise programme in pre-frail 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 pre-frail or frail, following Frailty Phenotype 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. Semi-structured 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 (Frailty Phenotype), 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 aim to publish findings in a peer-reviewed journal and present 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.