This systematic review will be prepared according to the criteria of the Preferred Reporting Items for Systematic review and Meta-Analysis Protocols - PRISMA-P [18, 19]. We adopted the “PICO” structure and defined it as follows: “P” represents elderly people, “I” represents physical exercise, “C” represents without physical exercise, and “O” represents osteosarcopenia.
Eligibility criteria
Controlled, randomized, blind, or open clinical trials will be included that performed an intervention with any modality of physical exercise with a minimum time of four weeks, conducted with elderly people (age ≥ 65 years) of both sexes, diagnosed with osteosarcopenia, i.e., individuals with osteopenia (T-score − 2.5 to <-1) and osteoporosis (T-score ≤ -2.5) according to the World Health Organization (WHO) diagnostic criteria [3], and sarcopenia according to a grant from the European Working Group on Sarcopenic in Older People (EWGSOP) [5, 20], without language restrictions and period of publication.
Studies with hospitalized elderly people, which focused on specific conditions, e.g., stroke, will be excluded. Observational studies, opinion articles, editorials, narrative reviews, case series and comments, duplicate studies and publications that present data unavailability even after asking the authors.
Database
Our search strategy will be conducted in four databases (PubMed (National Library of Medicine), Embase, Cochrane, and Scopus). In addition, the GreyNet International platform will be used to locate productions referring to gray literature internationally as well as Google Scholar. To complement the search and ensure the saturation of the literature, the references of the selected articles will also be considered.
Search terms were selected using the MeSH (Medical Subject Headings) for the PubMed database. Search: ((Osteosarcopenia [Title/Abstract]) AND (((((exercise [MeSH Terms]) OR (exercise [Title/Abstract])) OR (physical activity [Title/Abstract])) OR (physical activities [Title/Abstract])) OR (“Physical Fitness”[Title/Abstract]))) AND ((((((((aged[MeSH Terms]) OR (aged[Title/Abstract])) OR (elderly[Title/Abstract])) OR (older adult [Title/Abstract])) OR (older adults [Title/Abstract])) OR (elder[Title/Abstract])) OR (Ageing[Title/Abstract])) OR (aging[Title/Abstract])). The same search strategy model was adapted to Embase, Cochrane, and Scopus databases.
Review Process
The search for articles will be carried out by two independent researchers (GVS, MN) and a third senior reviewer (EAS). The inclusion of articles will be carried out by reading the titles, and later by reading the abstracts. Finally, the complete content will be analyzed for inclusion.
After executing the search strategy, articles will be collated, and duplicates will be removed using Mendeley Software. Then, two reviewers (GVS and MN) will independently screen the titles and abstracts of all articles identified in the literature search for inclusion. Disagreement regarding inclusion will be discussed and resolved by a third reviewer (EAS). The screening process will be performed for both reviewers using Rayyan Software [21]. Inter-rater reliability for individual component ratings will be determined by calculating the percentage of agreement and the Cohen's Kappa coefficient [22]. The remaining articles will be read in full and evaluated to determine their eligibility based on the inclusion and exclusion criteria. Finally, the eligible articles will be included in the systematic review.
We will prepare a flowchart with information about the screening of studies, the included studies and the reasons for excluding others, the recording and viewing of this process, following the recommendation of PRISMA-P.
Data extraction and study quality assessment
To extract data from an article, a standardized form prepared by the authors will be used. The following items will be considered: author / year of publication, place of study, age group studied, sample size, intervention performed, time of intervention, and main results.
To assess the risk of bias, the Grading of Recommendations, Assessment, Development and Evaluations - GRADE [23] and Black and Downs [24] tools will be used. For each research result, the quality of the evidence will ultimately receive one of four scores: high quality, moderate quality, low quality, or very low quality [25]. We will also analyze whether the authors of the included studies addressed the impact of possible conflicts of interest and information regarding ethical approval [26].
Data analysis
The outcome of this study will be the improvement in osteosarcopenia (bone mineral density, appendicular muscle mass, muscle strength, and function) in elderly people. The possibility of meta-analysis will be assessed according to the homogeneity of the studies, using the methods of fixed or random effect. The Chi-square test will be applied to assess heterogeneity, with a significance level of p < 0.05. The I-square (I2) statistic will be used to assess the magnitude of inconsistency, which will point to high heterogeneity when the results are greater than 75%, moderate heterogeneity when the results are between 25–75%, and an I2 less than 25% will demonstrate low heterogeneity [27, 28]. Sensitivity analyses will be performed, and the funnel plot will be used to assess publication bias. The proposed statistical analyses will be performed using the STATA Software, version 14.0.