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      Feasibility, effectiveness and acceptability of two perturbation-based treadmill training protocols to improve reactive balance in fall-prone older adults (FEATURE): protocol for a pilot randomised controlled trial

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          Abstract

          Introduction

          Perturbation-based balance training (PBT) targets the mechanism of falls (eg, slipping, tripping) to specifically train the recovery actions needed to avoid a fall. This task-specific training has shown great promise as an effective and efficient intervention for fall prevention in older adults. However, knowledge about the dose–response relationship of PBT, as well as its feasibility and acceptability in older adults with increased risk of falling is still limited. Thus, the aim of this study is to compare the effectiveness of two different treadmill PBT protocols for improving reactive balance control in fall-prone older adults, and to evaluate the feasibility and acceptability of these protocols.

          Methods and analysis

          The study is designed as a pilot randomised controlled trial with a 6-week intervention and 6-week follow-up period. Thirty-six community-dwelling, fall-prone (Timed Up and Go >12 s, habitual gait speed <1.0 m/s and/or fall history) older adults will be randomised (1:1) to receive six (weeks 1–6) or two treadmill PBT sessions (weeks 1+6) plus four conventional treadmill training sessions (weeks 2–5). Training sessions are conducted 1×/week for 30 min. Each PBT will include 40 perturbations in anterior–posterior and mediolateral directions. Reactive balance after perturbations in standing (Stepping Threshold Test (STT)) and walking (Dynamic Stepping Threshold Test (DSTT)) will be assessed as the primary outcome for effectiveness. Secondary outcomes are spatiotemporal and kinematic parameters collected during STT, DSTT and PBT, maximum perturbation magnitude for each PBT session, static and dynamic balance, physical capacity, physical activity, concerns with falling and executive functions. Feasibility will be assessed via training adherence, drop-out rate, perturbations actually performed and adverse events; and acceptability via self-designed questionnaire and focus groups.

          Ethics and dissemination

          The study has been approved by the Ethics Committee of the Medical Faculty Heidelberg (S-602/2022). Findings will be disseminated through publications in peer-reviewed journals and conference presentations.

          Trial registration number

          DRKS00030805.

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          Most cited references77

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          "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician.

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            Frailty in Older Adults: Evidence for a Phenotype

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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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                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
                2023
                4 September 2023
                : 13
                : 9
                : e073135
                Affiliations
                [1 ]departmentGeriatric Center , Heidelberg University Hospital , Heidelberg, Germany
                [2 ]departmentInstitute of Computer Engineering , Ringgold_9144Heidelberg University , Heidelberg, Germany
                [3 ]departmentInstitute for Sports and Sports Science , Ringgold_9144Heidelberg University , Heidelberg, Germany
                [4 ]departmentUnit of Digital Geriatric Medicine , Heidelberg University Hospital , Heidelberg, Germany
                Author notes
                [Correspondence to ] Dr Christian Werner; christian.werner@ 123456uni-heidelberg.de
                Author information
                http://orcid.org/0000-0003-0679-3227
                Article
                bmjopen-2023-073135
                10.1136/bmjopen-2023-073135
                10481747
                37666555
                eaf3f919-515c-4468-9351-c4eab0aa82df
                © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 24 February 2023
                : 14 August 2023
                Categories
                Geriatric Medicine
                1506
                1698
                Protocol
                Custom metadata
                unlocked

                Medicine
                aged,clinical trial,geriatric medicine,sports medicine
                Medicine
                aged, clinical trial, geriatric medicine, sports medicine

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