# Outcomes in clinical trials on sarcopenia: a systematic review and meta-analysis

## TL;DR

This study reviews clinical trials on sarcopenia to assess commonly used endpoints and their alignment with recommended standards, highlighting the need for consistent measures to improve trial comparability.

## Contribution

The study systematically evaluates endpoint usage in sarcopenia trials and identifies gaps in defining minimal clinically important differences.

## Key findings

- Physical performance and body composition were the most commonly used outcomes in sarcopenia trials.
- Meta-analysis showed significant moderate effects for TUG, ASMI, handgrip strength, and CRT.
- Quality of Life was rarely measured, and minimal clinically important differences were seldom defined.

## Abstract

In order to improve the quality and comparability of intervention studies, common endpoints have gained significance. The European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) consensus paper identified suitable endpoints for trials investigating the treatment of sarcopenia.

With the help of a systematic review, we analyzed which endpoints have been used in randomized controlled intervention trials investigating the treatment of sarcopenia to date, to what extent these correspond to the recommended endpoints of the ESCEO consensus and whether minimal clinically important differences (MCID) were defined. Based on these identified endpoints we also aimed to identify which type of intervention may be most effective in enhancing the investigated endpoint.

A systematic search (PROSPERO ID: CRD42023468128) was carried out in various databases (PubMed, Embase, PsychInfo, Web of Science, Trial Registers) to find studies meeting the following criteria for further analysis: randomized controlled trials (RCTs), geriatric study population, sarcopenia (including probable sarcopenia and sarcopenic obesity), intervention study, published until October 2023 and written in English. The meta-analysis was conducted for the most common outcomes.

Ninety publications met the criteria and were analyzed as full texts. The 90 intervention studies used a variety of different diagnostic criteria, intervention types and study settings. Measures of physical performance/strength (85 trials) and body composition (77 trials) were the most commonly used outcomes; in 74 studies, both outcome categories were used. Quality of Life was used in only 13 studies. In all categories, a very high heterogeneity between the measures was found and MCIDs were only rarely defined.

Meta-analysis showed significant moderate intervention effects for the Timed-Up and Go-Test (TUG) and appendicular skeletal muscle index (ASMI), Handgrip strength and Chair Rise Test (CRT). The Short Physical Performance Battery (SPPB) showed no significant effects.

Our results highlight the heterogeneity among sarcopenia intervention studies, which impairs the comparability regarding the efficiency of different interventions. However, our findings support the need for core outcomes or pre-defined common endpoints, for which the updated ESCEO recommendations can serve as a solid basis. Nevertheless, more consistent data are needed to enable a proper meta-analysis.