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      Adherence, safety and potential effectiveness of a home‐based Radio‐Taiso exercise program in older adults with frailty: A pilot randomized controlled trial

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          Abstract

          Aim

          Radio‐Taiso, a traditional exercise program in Japan, may serve as a coping strategy for older adults with frailty during the COVID‐19 pandemic. This phase II trial tested program adherence and safety and explored the potential effectiveness of a home‐based Radio‐Taiso.

          Methods

          This assessor‐blind parallel randomized controlled trial included community‐dwelling Jolder Japanese adults with frailty and pre‐frailty. Fifty‐eight eligible participants were randomly allocated to intervention and control groups. Intervention participants performed 3–5‐min sessions of Radio‐Taiso one to four times per day for 12 weeks. Feasibility criteria were set at practice and retention rates of ≥75%. Safety was monitored by assessing all adverse events reported by participants during the intervention period, irrespective of causality. Potential effectiveness was exploratorily assessed using items that allow clinical interpretation of changes: mobility and health‐related quality of life (HR‐QoL), assessed using the modified short physical performance battery (SPPB) and the SF‐36, respectively.

          Results

          Both practice (83%) and retention rates (100%) met the predetermined feasibility criteria. Eleven adverse events were reported but were supposedly unrelated to the intervention. In the intention‐to‐treat analysis, there was no clinically significant difference in the change in SPPB score between groups (−0.4 points, 95% confidence interval [CI], −1.2, 0.3); however, the intervention group scored higher in the mental component of HR‐QoL than did the control group (3.4 points, 95% CI: −1.1, 7.8).

          Conclusions

          The preliminary data indicate that a phase III trial is feasible, focusing on the mental aspect of HR‐QoL as the primary outcome. Geriatr Gerontol Int 2023; 23: 32–37.

          Abstract

          A traditional exercise program called Radio‐Taiso might be a reasonable coping strategy for older Japanese adults with frailty and pre‐frailty during the COVID‐19 pandemic, but no large‐scale clinical trial has evaluated the effectiveness of Radio‐Taiso on clinically important outcomes in this population. This phase II trial tested the adherence, safety and potential effectiveness of a home‐based Radio‐Taiso exercise program, and we examined the feasibility of a phase III trial. Our preliminary data indicated that the phase III trial will be feasible if the mental aspect of health‐related quality of life is used as the primary outcome.

          Adherence, safety, and potential effectiveness of a home‐based Radio‐Taiso exercise program in older adults with frailty.

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          Most cited references25

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          Frailty in Older Adults: Evidence for a Phenotype

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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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              CONSORT 2010 statement: extension to randomised pilot and feasibility trials

              The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply. The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist. The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge whether or how to proceed with a future definitive RCT; if relevant, other important unintended consequences; implications for progression from pilot to future definitive RCT, including any proposed amendments; and ethical approval or approval by a research review committee confirmed with a reference number. This article includes the 26 item checklist, a separate checklist for the abstract, a template for a CONSORT flowchart for these studies, and an explanation of the changes made and supporting examples. We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials. Editor’s note: In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites.
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                Author and article information

                Contributors
                osuka@tmig.or.jp
                Journal
                Geriatr Gerontol Int
                Geriatr Gerontol Int
                10.1111/(ISSN)1447-0594
                GGI
                Geriatrics & Gerontology International
                John Wiley & Sons Australia, Ltd (Kyoto, Japan )
                1444-1586
                1447-0594
                25 November 2022
                January 2023
                : 23
                : 1 ( doiID: 10.1111/ggi.v23.1 )
                : 32-37
                Affiliations
                [ 1 ] Research Team for Promoting Independence and Mental Health Tokyo Metropolitan Institute of Gerontology Itabashi‐ku Japan
                [ 2 ] Department of Cardiology Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology Itabashi‐ku Japan
                [ 3 ] Department of Biostatistics, Faculty of Medicine University of Tsukuba Tsukuba Japan
                [ 4 ] Japan Radio‐Taiso Federation Chiyoda‐ku Japan
                [ 5 ] Department of Preventive Medicine and Public Health Tokyo Medical University Shinjyuku‐ku Japan
                Author notes
                [*] [* ] Correspondence

                Yosuke Osuka PhD, Research Team for Promoting Independence and Mental Health, Tokyo Metropolitan Institute of Gerontology, 35‐2 Sakae‐cho, Itabashi‐ku, Tokyo 173‐0015, Japan.

                Email: osuka@ 123456tmig.or.jp

                Author information
                https://orcid.org/0000-0002-5744-1961
                https://orcid.org/0000-0001-5742-0389
                https://orcid.org/0000-0001-9684-7713
                https://orcid.org/0000-0003-1614-5477
                Article
                GGI14511
                10.1111/ggi.14511
                10100027
                36426763
                da8daec4-1c23-454e-9681-f387790d273b
                © 2022 The Authors. Geriatrics & Gerontology International published by John Wiley & Sons Australia, Ltd on behalf of Japan Geriatrics Society.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

                History
                : 21 October 2022
                : 11 July 2022
                : 02 November 2022
                Page count
                Figures: 2, Tables: 4, Pages: 6, Words: 4936
                Funding
                Funded by: Nakatomi Foundation , doi 10.13039/100008731;
                Funded by: Japan Post Insurance Co., Ltd.
                Categories
                Original Article
                Original Articles: Epidemiology, Clinical Practice and Health
                Custom metadata
                2.0
                January 2023
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.2.7 mode:remove_FC converted:13.04.2023

                exercise,feasibility study,frailty,randomized controlled trial,safety

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