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      Exercise for people living with frailty and receiving haemodialysis: a mixed-methods randomised controlled feasibility study

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          Abstract

          Objectives

          Frailty is highly prevalent in haemodialysis (HD) patients, leading to poor outcomes. This study aimed to determine whether a randomised controlled trial (RCT) of intradialytic exercise is feasible for frail HD patients, and explore how the intervention may be tailored to their needs.

          Design

          Mixed-methods feasibility.

          Setting and participants

          Prevalent adult HD patients of the CYCLE-HD trial with a Clinical Frailty Scale Score of 4–7 (vulnerable to severely frail) were eligible for the feasibility study.

          Interventions

          Participants in the exercise group undertook 6 months of three times per week, progressive, moderate intensity intradialytic cycling (IDC).

          Outcomes

          Primary outcomes were related to feasibility. Secondary outcomes were falls incidence measured from baseline to 1 year following intervention completion, and exercise capacity, physical function, physical activity and patient-reported outcomes measured at baseline and 6 months. Acceptability of trial procedures and the intervention were explored via diaries and interviews with n=25 frail HD patients who both participated in (n=13, 52%), and declined (n=12, 48%), the trial.

          Results

          124 (30%) patients were eligible, and of these 64 (52%) consented with 51 (80%) subsequently completing a baseline assessment. n=24 (71% male; 59±13 years) dialysed during shifts randomly assigned to exercise and n=27 (81% male; 65±11 years) shifts assigned to usual care. n=6 (12%) were lost to follow-up. The exercise group completed 74% of sessions. 27%–89% of secondary outcome data were missing. Frail HD patients outlined several ways to enhance trial procedures. Maintaining ability to undertake activities of daily living and social participation were outcomes of primary importance. Participants desired a varied exercise programme.

          Conclusions

          A definitive RCT is feasible, however a comprehensive exercise programme may be more efficacious than IDC in this population.

          Trial registration numbers

          ISRCTN11299707; ISRCTN12840463.

          Related collections

          Most cited references49

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          Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide

          Without a complete published description of interventions, clinicians and patients cannot reliably implement interventions that are shown to be useful, and other researchers cannot replicate or build on research findings. The quality of description of interventions in publications, however, is remarkably poor. To improve the completeness of reporting, and ultimately the replicability, of interventions, an international group of experts and stakeholders developed the Template for Intervention Description and Replication (TIDieR) checklist and guide. The process involved a literature review for relevant checklists and research, a Delphi survey of an international panel of experts to guide item selection, and a face to face panel meeting. The resultant 12 item TIDieR checklist (brief name, why, what (materials), what (procedure), who provided, how, where, when and how much, tailoring, modifications, how well (planned), how well (actual)) is an extension of the CONSORT 2010 statement (item 5) and the SPIRIT 2013 statement (item 11). While the emphasis of the checklist is on trials, the guidance is intended to apply across all evaluative study designs. This paper presents the TIDieR checklist and guide, with an explanation and elaboration for each item, and examples of good reporting. The TIDieR checklist and guide should improve the reporting of interventions and make it easier for authors to structure accounts of their interventions, reviewers and editors to assess the descriptions, and readers to use the information.
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            Frailty in elderly people

            Frailty is the most problematic expression of population ageing. It is a state of vulnerability to poor resolution of homoeostasis after a stressor event and is a consequence of cumulative decline in many physiological systems during a lifetime. This cumulative decline depletes homoeostatic reserves until minor stressor events trigger disproportionate changes in health status. In landmark studies, investigators have developed valid models of frailty and these models have allowed epidemiological investigations that show the association between frailty and adverse health outcomes. We need to develop more efficient methods to detect frailty and measure its severity in routine clinical practice, especially methods that are useful for primary care. Such progress would greatly inform the appropriate selection of elderly people for invasive procedures or drug treatments and would be the basis for a shift in the care of frail elderly people towards more appropriate goal-directed care. Copyright © 2013 Elsevier Ltd. All rights reserved.
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              Developing and evaluating complex interventions: the new Medical Research Council guidance

              Evaluating complex interventions is complicated. The Medical Research Council's evaluation framework (2000) brought welcome clarity to the task. Now the council has updated its guidance
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2020
                3 November 2020
                : 10
                : 11
                : e041227
                Affiliations
                [1 ]departmentDepartment of Respiratory Sciences , University of Leicester , Leicester, UK
                [2 ]departmentDepartment of Research and Innovation , University Hospitals of Leicester NHS Trust , Leicester, UK
                [3 ]departmentDepartment of Cardiovascular Sciences , University of Leicester , Leicester, UK
                [4 ]departmentNational Centre for Sport and Exercise Medicine , Loughborough University , Loughborough, UK
                [5 ]departmentDepartment of Health Sciences , University of Leicester , Leicester, UK
                [6 ]departmentEmergency Department, Leicester Royal Infirmary , University Hospitals of Leicester NHS Trust , Leicester, UK
                [7 ]departmentRenal, Respiratory and Cardiovascular Clinical Management Group , University Hospitals of Leicester NHS Trust , Leicester, UK
                [8 ]departmentDepartment of Physiotherapy and Renal Medicine , King’s College Hospital , London, UK
                [9 ]departmentDepartment of Renal Medicine , King’s College London , London, UK
                [10 ]departmentUsher Institute , University of Edinburgh , Edinburgh, United Kingdom
                [11 ]departmentCentre for Exercise and Rehabilitation Science , Leicester Biomedical Research Unit , Leicester, UK
                [12 ]departmentDepartment of Respiratory Medicine, Glenfield Hospital , University Hospitals of Leicester NHS Trust , Leicester, UK
                Author notes
                [Correspondence to ] Hannah M L Young; hmly1@ 123456le.ac.uk
                Author information
                http://orcid.org/0000-0002-4249-9060
                Article
                bmjopen-2020-041227
                10.1136/bmjopen-2020-041227
                7640592
                33148767
                6a732f2d-f0fd-489a-8de8-60743653c36e
                © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See:  https://creativecommons.org/licenses/by/4.0/.

                History
                : 03 June 2020
                : 06 September 2020
                : 10 September 2020
                Funding
                Funded by: National Institute of Health Research;
                Award ID: CS-2013-13-014
                Award ID: DRF-2016-09-015
                Categories
                Renal Medicine
                1506
                1728
                Original research
                Custom metadata
                unlocked

                Medicine
                dialysis,end stage renal failure,rehabilitation medicine,qualitative research,clinical trials

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