The EX-FRAIL CKD trial:A pilot RCT of a home-based Exercise programme for pre-FRAIL and FRAIL, older adults with CKD

Nixon, A.C. and Bampouras, T.M. and Gooch, H.J. and Young, H.M. and Finlayson, K.W. and Pendleton, N. and Mitra, S. and Brady, M.E. and Dhaygude, A.P. (2021) The EX-FRAIL CKD trial:A pilot RCT of a home-based Exercise programme for pre-FRAIL and FRAIL, older adults with CKD. Physiotherapy, 113. e7-e8. ISSN 0031-9406

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Purpose: 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 or over with CKD G3b-5 and a Clinical Frailty Scale score 4 or above were eligible. Participants categorised as pre-frail or frail, following Frailty Phenotype (FP) assessment, were randomised to receive a physiotherapist-led, tailored, 12-week home-based exercise programme or usual care. 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]) and health-related quality of life (Short Form-12v2 [SF-12]). Progression criteria to RCT stage were: (1) eligibility >10%; (2) recruitment >30%; (3) exercise adherence >70%; (4) outcome measure completion >80%; and (5) loss to follow-up <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 Six participants were categorised as robust and therefore were withdrawn prior to randomisation.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/1.73 m2) and 14 to usual care (mean age 78.8 ± 7.0 years; mean eGFR 20.4 ± 7.2 ml/min/1.73 m2). Exercise adherence (average of 2 or more exercise sessions/week) was achieved by 73% (95% CI 45-92). 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. The odds ratio for improvement in frailty status with exercise was 5.50 (95% CI 0.46-65.16) and for deterioration in frailty status was 0.63 (95% CI 0.05-8.20). The adjusted mean group differences in walking speed, grip strength, SPPB score, SF-12 Physical Component Summary score and SF-12 Mental Component Summary score between exercise and usual care groups were: 0.01 metres/second (95% CI −0.07-0.10), 3.6 kg (95% CI −0.6-7.9), 0.5 (95% CI −0.9-1.8), −3.9 (95% CI −9.3-1.5) and 0.2 (95% CI −6.2-6.6), respectively. Conclusion(s): 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 older adults living with frailty and CKD. Impact: The results of this study will be used to inform the development of a definitive RCT providing opportunities for physiotherapists working within renal centres to participate. If the definitive RCT demonstrates benefit, it will support the case for a physiotherapist guided, home-based exercise programme within routine clinical care.

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21 Feb 2022 11:20
Last Modified:
16 Sep 2023 02:26