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

IntroductionFrailty 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 analysisThe 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 disseminationEthical 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 numberISRCTN87708989.

A Study of the Efficacy and Safety of Aerobic Exercise Training in Pulmonary Arterial Hypertension (the Saturday Study): Protocol for a Prospective, Randomized, and Controlled Trial

“…(b) Uncontrolled hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg), unstable arrhythmias, angina or myocardial infarction, stroke or transient ischemic attach (within 3 months) ( 20 ).…”

Home-based exercise for people living with frailty and chronic kidney disease: A mixed-methods pilot randomised controlled trial

“…This section will present an abridged version of the methods; a full description of the methods has been published elsewhere [24]. Ethical approval was granted by the North West Greater Manchester East Research Ethics Committee (reference 18/NW/0211) and the National Health Service (NHS) Health Research Authority (project reference 244772).…”

“…Briefly, exercise group participants received a physiotherapistled exercise education session, an exercise guidebook and weekly telephone-calls from the research team. The multi-component exercise programme comprised a combination of strength, aerobic and balance exercises [24]. There were six exercises within the programme, with each having four different levels of difficulty.…”

“…An overview of secondary outcome measures is provided below; a detailed description has been published previously [24]. All measures were performed at baseline and at 12-week follow-up visits.…”

“…Interviews and transcripts were regularly discussed and reviewed with KWF for potential bias concerns. Further detail on the interviews has been published previously [24].…”