Dataset Information

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, multicomponent home-based exercise programme in prefrail 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 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 dissemination

Ethical 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 number

ISRCTN87708989.

SUBMITTER: Nixon AC

PROVIDER: S-EPMC7311028 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Publications

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.

Nixon Andrew Christopher AC Bampouras Theodoros M TM Gooch Helen J HJ Young Hannah M L HML Finlayson Kenneth William KW Pendleton Neil N Mitra Sandip S Brady Mark E ME Dhaygude Ajay P AP

BMJ open 20200622 6

<h4>Introduction</h4>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 t ...[more]

PMID: 32571859

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Project description:BACKGROUND:Due to the demographic ageing process and the increasing number of pre-frail and frail individuals, new lifestyle interventions to enhance the quality of life (QoL) in community-dwelling older adults are necessary. Therefore, we performed a randomised controlled trial (RCT) to compare effects of a lay-led home-based physical and nutritional intervention programme with social support alone on different QoL domains in community-dwelling pre-frail and frail older adults. METHODS:In this analysis within a RCT (12 weeks), lay volunteers visited one-on-one pre-frail or frail older adults at home twice a week. Participants in the physical training and nutritional intervention (PTN) group performed six strength exercises and discussed main nutritional issues during each visit. The social support (SOSU) group received home visits twice a week for social exchanges. The QoL was assessed with the WHOQOL-BREF and the WHOQOL-OLD instruments. Analyses of covariance (ANCOVA) were used to examine differences between groups with baseline values as the covariate. Changes within groups were assessed with paired t-tests. RESULTS:Eighty participants (n = 39 in the PTN group and n = 41 in the SOSU group) were included. No significant differences were found between the two groups except in past, present and future activities domain [? = 3.66 (95% confidence interval 0.13 to 7.18)] in favour of the PTN group. However, there was some evidence of greater within group improvements in the PTN group particularly in overall QoL, social relations and social participation. In the SOSU group, no significant effect was observed in any QoL domain. CONCLUSION:A combination of a home-based physical and nutritional intervention was not more effective compared to social support alone, on QoL in community-dwelling pre-frail and frail older adults. However, the small but significant improvement within the PTN group suggests that a home-based physical and nutritional intervention delivered by volunteers may influence the QoL in a positive way. TRIAL REGISTRATION:The study protocol was registered on 6 November 2013 at ClinicalTrials.gov (identifier: NCT01991639 ).

Project description:ObjectiveTo investigate the efficacy of a programme of manual therapy and exercise treatment compared with placebo treatment delivered by physiotherapists for people with chronic rotator cuff disease.DesignRandomised, participant and single assessor blinded, placebo controlled trial.SettingMetropolitan region of Melbourne, Victoria, Australia.Participants120 participants with chronic (>3 months) rotator cuff disease recruited through medical practitioners and from the community.InterventionsThe active treatment comprised a manual therapy and home exercise programme; the placebo treatment comprised inactive ultrasound therapy and application of an inert gel. Participants in both groups received 10 sessions of individual standardised treatment over 10 weeks. For the following 12 weeks, the active group continued the home exercise programme and the placebo group received no treatment.Main outcome measuresThe primary outcomes were pain and function measured by the shoulder pain and disability index, average pain on movement measured on an 11 point numerical rating scale, and participants' perceived global rating of overall change.Results112 (93%) participants completed the 22 week trial. At 11 weeks no difference was found between groups for change in shoulder pain and disability index (3.6, 95% confidence interval -2.1 to 9.4) or change in pain (0.7, -0.1 to 1.5); both groups showed significant improvements. More participants in the active group reported a successful outcome (defined as "much better"), although the difference was not statistically significant: 42% (24/57) of active participants and 30% (18/61) of placebo participants (relative risk 1.43, 0.87 to 2.34). The active group showed a significantly greater improvement in shoulder pain and disability index than did the placebo group at 22 weeks (between group difference 7.1, 0.3 to 13.9), although no significant difference existed between groups for change in pain (0.9, -0.03 to 1.7) or for the percentage of participants reporting a successful treatment outcome (relative risk 1.39, 0.94 to 2.03). Several secondary outcomes favoured the active group, including shoulder pain and disability index function score, muscle strength, interference with activity, and quality of life.ConclusionA standardised programme of manual therapy and home exercise did not confer additional immediate benefits for pain and function compared with a realistic placebo treatment that controlled for therapists' contact in middle aged to older adults with chronic rotator cuff disease. However, greater improvements were apparent at follow-up, particularly in shoulder function and strength, suggesting that benefits with active treatment take longer to manifest.Trial registrationClinical trials NCT00415441.

Project description:BackgroundCardiovascular disease (CVD) is a major cause of morbidity and mortality in kidney transplant recipients (KTRs). CVD risk scores underestimate risk in this population as CVD is driven by clustering of traditional and non-traditional risk factors, which lead to prognostic pathological changes in cardiovascular structure and function. While exercise may mitigate CVD in this population, evidence is limited, and physical activity levels and patient activation towards exercise and self-management are low. This pilot study will assess the feasibility of delivering a structured, home-based exercise intervention in a population of KTRs at increased cardiometabolic risk and evaluate the putative effects on cardiovascular structural and functional changes, cardiorespiratory fitness, quality of life, patient activation, healthcare utilisation and engagement with the prescribed exercise programme.Methods and analysisFifty KTRs will be randomised 1:1 to: (1) the intervention; a 12week, home-based combined resistance and aerobic exercise intervention; or (2) the control; usual care. Intervention participants will have one introductory session for instruction and practice of the recommended exercises prior to receiving an exercise diary, dumbbells, resistance bands and access to instructional videos. The study will evaluate the feasibility of recruitment, randomisation, retention, assessment procedures and the intervention implementation. Outcomes, to be assessed prior to randomisation and postintervention, include: cardiac structure and function with stress perfusion cardiac MRI, cardiorespiratory fitness, physical function, blood biomarkers of cardiometabolic health, quality of life and patient activation. These data will be used to inform the power calculations for future definitive trials.Ethics and disseminationThe protocol was reviewed and given favourable opinion by the East Midlands-Nottingham 2 Research Ethics Committee (reference: 19/EM/0209; 14 October 2019). Results will be published in peer-reviewed academic journals and will be disseminated to the patient and public community via social media, newsletter articles and presentations at conferences.Trial registration numberNCT04123951.

Project description:ObjectivesTo gain first insight into the effectiveness of a home-based exercise programme for pre-frail older adults with independent use of novel ICT technology.MethodsA pilot study. Forty pre-frail older adults joined a six-month home-based exercise programme using a tablet PC for exercise administration and feedback, and a necklace-worn motion sensor for daily physical activity registration. Participants received weekly telephone supervision during the first 3 months and exercised independently without supervision from a coach during the last 3 months. Functional performance and daily physical activity were assessed at baseline, after three and 6 months.ResultsTwenty-one participants completed the programme. Overall, functional performance showed positive results varying from (very) small to large effects (Cohen's d 0.04-0.81), mainly during the supervised part of the intervention. Regarding daily physical activity, a slight improvement with (very) small effects (Cohen's d 0.07-0.38), was observed for both self-reported and objectively measured physical activity during the supervised period. However, during the unsupervised period this pattern only continued for self-reported physical activity.ConclusionThis pilot study showed positive results varying from (very) small to large effects in levels and maintenance of functional performance and daily physical activity, especially during the supervised first 3 months. Remote supervision seems to importantly affect effectiveness of a home-based exercise programme. Effectiveness of the programme and the exact contribution of its components should be further quantified in a randomized controlled trial.Practice implicationsHome-based exercising using novel technology may be promising for functional performance and physical activity improvement in (pre-frail) older adults.Trial registrationNetherlands Trial Register (NTR); trial number NL4049 . The study was prospectively registered (registration date 14/11/2013).

Project description:BackgroundFrailty 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.MethodsParticipants 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.ResultsSix 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.ConclusionsThis 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 registrationISRCTN87708989; https://clinicaltrials.gov/.

Dataset Information

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.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

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.

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