Effectiveness and clinical application of multidisciplinary combined exercise and nutrition intervention for sarcopenic older adults with metabolic syndrome: study protocol for a multicentre randomised controlled trial

多学科联合运动和营养干预对伴有代谢综合征的肌少症老年人的有效性和临床应用:一项多中心随机对照试验的研究方案

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Abstract

INTRODUCTION: Among chronic diseases affecting older adults, metabolic syndrome (MetS) is known to be closely related to sarcopenia. Insulin resistance may play a key role in the increased frequency of sarcopenia associated with metabolic disorders. To date, an exercise-nutrition combined intervention has been the treatment of choice for sarcopenia. However, trials of combined interventions for individuals with sarcopenia and MetS are still lacking. This study aims to develop and conduct a standardised intervention, named the Multidisciplinary combined Exercise and Nutrition inTervention fOR Sarcopenia (MENTORS), for sarcopenic older patients with MetS. METHODS AND ANALYSIS: This multicentre, randomised controlled trial includes 168 community-dwelling older adults with sarcopenia and MetS. The 12-week MENTORS comprises an exercise intervention consisting of an introductory phase (3 weeks; twice-weekly visits), an expanded phase (3 weeks; twice-weekly visits) and a maintenance phase (6 weeks; once-weekly visits); and a nutrition intervention tailored to the nutritional status of individual subjects. Outcomes will be measured at 0-week, 12-week and 24-week postintervention. The data will be analysed using the intention-to-treat and per-protocol principle. ETHICS AND DISSEMINATION: Before screening, all participants will be provided with oral and written information. Ethical approval has already been obtained from all participating hospitals. The study results will be disseminated in peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT04948736.

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