Combating sarcopenia in geriatric rehabilitation patients: study protocol of the EMPOWER-GR observational cohort, sarcopenia awareness survey and randomised controlled feasibility trial

对抗老年康复患者肌少症:EMPOWER-GR观察性队列研究、肌少症认知调查和随机对照可行性试验的研究方案

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Abstract

INTRODUCTION: Sarcopenia is highly prevalent in geriatric rehabilitation patients. Resistance exercise training (RET) combined with protein supplementation is recommended to increase muscle mass and strength in older adults. However, sarcopenia awareness, feasibility to diagnose and treat sarcopenia, and efficacy of treatment in geriatric rehabilitation patients remain to be established. METHODS AND ANALYSIS: Enhancing Muscle POWER in Geriatric Rehabilitation (EMPOWER-GR) encompasses four pillars: (1) an observational cohort study of 200 geriatric rehabilitation inpatients determining sarcopenia prevalence, functional and nutritional status at admission; (2) a survey among these 200 patients and 500 healthcare professionals and semistructured interviews in 30 patients and 15 carers determining sarcopenia awareness and barriers/enablers regarding diagnostics and treatment; (3) a feasibility, single-centre, randomised, controlled, open-label, two parallel-group trial in 80 geriatric rehabilitation patients with sarcopenia. The active group (n=40) receives three RET sessions per week and a leucine and vitamin D-enriched whey protein-based oral nutritional supplement two times per day in combination with usual care for 13 weeks. The control group (n=40) receives usual care. Primary outcomes are feasibility (adherence to the intervention, dropout rate, overall feasibility) and change from baseline in absolute muscle mass at discharge and week 13. Secondary outcomes are feasibility (participation rate) and change from baseline at discharge and week 13 in relative muscle mass, muscle strength, physical and functional performance, mobility, nutritional status, dietary intake, quality of life and length of stay; institutionalisation and hospitalisation at 6 months and mortality at 6 months and 2 years; (4) knowledge sharing on sarcopenia diagnosis and treatment. ETHICS AND DISSEMINATION: Ethical exemption was received for the observational cohort study, ethics approval was received for the randomised controlled trial. Results will be disseminated through publications in scientific peer-reviewed journals, conferences and social media. TRIAL REGISTRATION NUMBER: NL9444.

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