{
  "abstract": "Introduction Although several systematic reviews and meta-analyses have demonstrated the benefits of exercise interventions in older adults with frailty, the potential harm associated with these interventions has not been systematically synthesised. This systematic review aims to examine the adverse events reported in exercise intervention trials involving older adults with frailty and to compare the risk of adverse events between the intervention and control groups.Methods and analysis Searches will be performed in four electronic databases (PubMed, Cochrane Library, Web of Science and SPORTDiscus) for published trials. Eligible studies will be randomised controlled trials of exercise interventions, including older adults with frailty aged ≥60 years, with frailty identified using a validated method. Five reviewers and three referees, all with expertise in exercise interventions, will be assigned to three independent review teams to ensure efficient screening. Reviewers will independently screen titles, abstracts and full texts using Rayyan, and then extract trial and adverse event data into an Excel spreadsheet. The risk of bias in eligible trials will be assessed using the Cochrane Risk of Bias 2 (RoB-2) tool. The referees will resolve any disagreements between the two reviewers throughout the screening, data extraction and risk-of-bias assessment processes. The primary outcome is adverse events, defined as any unfavourable, unintended signs, symptoms or disease that occurred during the study period. An independent biostatistician will perform a random-effects meta-analysis using a generalised linear mixed model with a binomial likelihood and a logit link to estimate the pooled risk ratios (RRs) for adverse events in the intervention group relative to the control group. Publication bias will be evaluated using funnel plots and Egger’s regression test. Depending on the number of available studies, subgroup analyses will be conducted to examine differences in RRs according to the study quality, duration of intervention, exercise frequency, setting and supervision.Ethics and dissemination Ethical approval was not required because we did not use specific patient data. The findings of the systematic review and meta-analysis will be disseminated through publication in a peer-reviewed journal and presentation at appropriate conferences.PROSPERO registration number CRD420251180645.",
  "authors": [
    {
      "affiliations": [
        "Department of Global Public Health, Institute of Medicine, University of Tsukuba, Tsukuba, Japan",
        "Department of Frailty Research, Center for Gerontology and Social Science, Research Institute, National Center for Geriatrics and Gerontology, Obu, Japan",
        "School of Psychology, Faculty of Science, University of New South Wales, Sydney, NSW, Australia",
        "UNSW Ageing Futures Institute, University of New South Wales, Sydney, NSW, Australia"
      ],
      "name": "Satoshi Kurita"
    },
    {
      "affiliations": [
        "Graduate School of Comprehensive Human Sciences, University of Tsukuba, Tsukuba, Japan"
      ],
      "name": "Ri Suo"
    },
    {
      "affiliations": [
        "Department of Biostatistics, Institute of Medicine, University of Tsukuba, Tsukuba, Japan",
        "Research Team for Promoting Independence and Mental Health, Tokyo Metropolitan Institute of Gerontology, Itabashi, Japan"
      ],
      "name": "Kazushi Maruo"
    },
    {
      "affiliations": [
        "Research Team for Promoting Independence and Mental Health, Tokyo Metropolitan Institute of Gerontology, Itabashi, Japan",
        "Department of Rehabilitation, Faculty of Health Sciences, Tokyo Kasei University, Sayama, Japan"
      ],
      "name": "Junji Nishimoto"
    },
    {
      "affiliations": [
        "School of Health and Sport Sciences, Chukyo University, Toyota, Japan"
      ],
      "name": "Takehiko Tsujimoto"
    },
    {
      "affiliations": [
        "Research Team for Promoting Independence and Mental Health, Tokyo Metropolitan Institute of Gerontology, Itabashi, Japan"
      ],
      "name": "Hiroyuki Sasai"
    },
    {
      "affiliations": [
        "School of Health and Sport Sciences, Chukyo University, Toyota, Japan"
      ],
      "name": "Ryosuke Shigematsu"
    },
    {
      "affiliations": [
        "Institute of Health and Sport Sciences, University of Tsukuba, Tsukuba, Japan"
      ],
      "name": "Yoshio Nakata"
    },
    {
      "affiliations": [
        "Department of Frailty Research, Center for Gerontology and Social Science, Research Institute, National Center for Geriatrics and Gerontology, Obu, Japan",
        "Research Team for Promoting Independence and Mental Health, Tokyo Metropolitan Institute of Gerontology, Itabashi, Japan",
        "College of Systems Engineering and Science, Shibaura Institute of Technology, Saitama, Japan"
      ],
      "name": "Yosuke Osuka"
    }
  ],
  "title": "Adverse events in exercise interventions among older adults with frailty: a study protocol of systematic review and meta-analysis",
  "uid": "84f734c3-8f89-59b7-b7f1-9982b1c7d542"
}