DOI: 10.5061/dryad.3ffbg79hp
title: Home-based exercise for people living with frailty and chronic kidney disease: a mixed-methods pilot randomised controlled trial

description: Background and Aims: Frailty is highly prevalent in adults with chronic
 kidney disease (CKD) and is associated with adverse health outcomes.
 However, exercise training may improve physical function leading to
 associated improvements in outcomes. The EX-FRAIL CKD trial
 (ISRCTN87708989) aimed to inform the design of a randomised controlled
 trial (RCT) that investigates the efficacy of a progressive home-based
 exercise programme in pre-frail and frail older adults with CKD. Methods:
 Patients aged ≥65 years with CKD G3b-5 and a Clinical Frailty Scale score
 ≥4 were eligible for participation. Participants categorised as pre-frail
 or frail, following Frailty Phenotype (FP) assessment, were randomised to
 receive a tailored 12-week home-based exercise programme or usual care
 (UC). Primary outcome measures included recruitment, intervention
 adherence, outcome measure completion and participant attrition rate.
 Secondary outcome measures included frailty status (FP), physical function
 (walking speed, handgrip strength and Short Physical Performance Battery
 [SPPB]), fall concern (Falls Efficacy Scale-International tool [FESI]),
 symptom-burden (Palliative Care Outcome Scale-Symptoms RENAL [POS-S
 RENAL]) and health-related quality of life (Short Form-12v2 [SF-12]).
 Outcome measures are reported descriptively with 95% confidence intervals
 (CI) as recommended for pilot trials. Progression criteria to RCT stage
 were defined as: (1) eligibility: STOP &lt;5%, GO &gt;10%; (2)
 recruitment: STOP &lt;10%, GO &gt;30%; (3) exercise adherence:
 STOP: &lt;30%, GO &gt;70%; (4) outcome measure completion: STOP
 &lt;70%, GO &gt;80%; and (5) loss to follow-up: STOP &gt;50%,
 GO &lt;25%. Results: Six hundred and sixty-five participants had an
 eligibility assessment with 201 (30% [95% CI 27-34]) patients eligible for
 enrolment. Thirty-five (17% [95% CI 12-23]) participants were recruited.
 Six participants were categorised as robust and therefore withdrawn prior
 to randomisation. Fifteen participants were randomised to exercise (mean
 age 77.0±8.3 years; mean eGFR 18.9±7.0 ml/min/1.73m2) and 14 to UC (mean
 age 78.8±7.0 years; mean eGFR 20.4±7.2 ml/min/1.73m2). Eleven (73% [95% CI
 45-92]) exercise group participants completed an average of ≥2 exercise
 sessions/week. Eight (28% [95% CI 13-47]) participants were lost to
 follow-up. Retained participants (n=21, 100% [95% CI 84-100]) completed
 all outcome measures. There were 32 adverse events in the exercise group
 and 22 in the UC group. Within the exercise group, there were 2
 hospitalisations (considered unrelated to exercise) and 12 adverse
 reactions: musculoskeletal pain (9), fall (1), nocturnal leg cramps (1)
 and postural dizziness (1). The odds ratio for improvement in frailty
 status with exercise was 5.50 (95% CI 0.46-65.16) and odds ratio for
 deterioration in frailty status was 0.63 (95% CI 0.05-8.20). The adjusted
 mean group difference in walking speed, grip strength and SPPB between
 exercise and UC groups were: 0.01 metres/second (95% CI -0.07-0.10), 3.6
 kg (95% CI -0.6-7.9) and 0.5 (95% CI -0.9-1.8), respectively. The adjusted
 mean group difference in POS-S RENAL, FESI, SF-12 Physical Component
 Summary and SF-12 Mental Component Summary scores were: -1.4 (95% CI
 -6.6-3.7), 3.4 (95% CI -3.5-10.3), -3.9 (95% CI -9.3-1.5) and 0.2 (95% CI
 -6.2-6.6), respectively. Conclusion: Eligibility, adherence and outcome
 measure progression criteria thresholds were exceeded; however,
 recruitment and loss to follow-up progression criteria thresholds were not
 achieved. Analysis of a nested qualitative study will explore perceived
 barriers to participation and retention. The EX-FRAIL CKD trial
 demonstrates that it is possible to progress to a definitive RCT with
 adaptations that address the barriers described. It has also provided
 preliminary evidence that frailty status and physical function may be
 improved with a home-based exercise programme in patients living with
 frailty and CKD.
description: This dataset
 contains data from The EX-FRAIL CKD Trial, which is a pilot randomised
 controlled trial (RCT) that aims to inform the design of a definitive
 RCT evaluating the effectiveness of a home-based exercise intervention for pre-frail and frail older adults with CKD. The study protocol has been published Open Access:  Nixon AC, Bampouras TM, Gooch HJ, et al. 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 2020;10:e035344. doi:10.1136/bmjopen-2019-035344