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 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 ph...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2020-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/6/e035344.full |
| _version_ | 1818870752702627840 |
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| author | Kenneth William Finlayson Andrew Christopher Nixon Theodoros M Bampouras Helen J Gooch Hannah M L Young Neil Pendleton Sandip Mitra Mark E Brady Ajay P Dhaygude |
| author_facet | Kenneth William Finlayson Andrew Christopher Nixon Theodoros M Bampouras Helen J Gooch Hannah M L Young Neil Pendleton Sandip Mitra Mark E Brady Ajay P Dhaygude |
| author_sort | Kenneth William Finlayson |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-19T12:12:01Z |
| format | Article |
| id | doaj.art-b7725ede32344bbdb7b6fe1eb074b16f |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-12-19T12:12:01Z |
| publishDate | 2020-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-b7725ede32344bbdb7b6fe1eb074b16f2022-12-21T20:22:10ZengBMJ Publishing GroupBMJ Open2044-60552020-06-0110610.1136/bmjopen-2019-035344The 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 DiseaseKenneth William Finlayson0Andrew Christopher Nixon1Theodoros M Bampouras2Helen J Gooch3Hannah M L Young4Neil Pendleton5Sandip Mitra6Mark E Brady7Ajay P Dhaygude8Research in Childbirth and Health Unit, University of Central Lancashire, Preston, Lancashire, UKDepartment of Renal Medicine, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, Lancashire, UKLancaster Medical School, Lancaster University, Lancaster, Lancashire, UKCentre for Health Research and Innovation, NIHR Lancashire Clinical Research Facility, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, Lancashire, UKDepartment of Respiratory Sciences, University of Leicester, Leicester, UKDivision of Neuroscience and Experimental Psychology, The University of Manchester, Manchester, UKManchester Academic Health Sciences Centre, The University of Manchester, Manchester, UKDepartment of Renal Medicine, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, Lancashire, UKDepartment of Renal Medicine, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, Lancashire, UKIntroduction 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.https://bmjopen.bmj.com/content/10/6/e035344.full |
| spellingShingle | Kenneth William Finlayson Andrew Christopher Nixon Theodoros M Bampouras Helen J Gooch Hannah M L Young Neil Pendleton Sandip Mitra Mark E Brady Ajay P Dhaygude 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/10/6/e035344.full |
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