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.
Background Frailty is associated with adverse health outcomes in people with chronic kidney disease (CKD). Evidence supporting targeted interventions is needed. This pilot randomised controlled trial (RCT) aimed 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. Methods Participants were recruited from nephrology outpatient clinics to this two-arm parallel group mixed-methods pilot RCT. Inclusion criteria were: ≥65 years old; CKD G3b-5; and Clinical Frailty Scale score ≥4. Participants categorised as pre-frail or frail using the Frailty Phenotype were randomised to a 12-week progressive multi-component home-based exercise programme or usual care. Primary outcome measures included eligibility, recruitment, adherence, outcome measure completion and participant attrition rate. Semi-structured interviews were conducted with participants to explore trial and intervention acceptability. Results Six hundred and sixty-five patients had an eligibility assessment with 217 (33%; 95% CI 29, 36) eligible. Thirty-five (16%; 95% CI 12, 22) participants were recruited. Six were categorised as robust and withdrawn prior to randomisation. Fifteen participants were randomised to exercise and 14 to usual care. Eleven (73%; 95% CI 45, 91) participants completed ≥2 exercise sessions/week. Retained participants completed all outcome measures (n = 21; 100%; 95% CI 81, 100). Eight (28%; 95% CI 13, 47) participants were withdrawn. Fifteen participated in interviews. Decision to participate/withdraw was influenced by perceived risk of exercise worsening symptoms. Participant perceived benefits included improved fitness, balance, strength, well-being, energy levels and confidence. Conclusions This pilot RCT demonstrates that progression to definitive RCT is possible provided recruitment and retention challenges are addressed. It has also provided preliminary evidence that home-based exercise may be beneficial for people living with frailty and CKD. Trial registration ISRCTN87708989; https://clinicaltrials.gov/.
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 <5%, GO >10%; (2) recruitment: STOP <10%, GO >30%; (3) exercise adherence: STOP: <30%, GO >70%; (4) outcome measure completion: STOP <70%, GO >80%; and (5) loss to follow-up: STOP >50%, GO <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.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.