Shen Shan-Shan, Chu Jiao-Jiao, Cheng Lei, Zeng Xing-Kun, He Ting, Xu Li-Yu, Li Jiang-Ru, Chen Xu-Jiao
Department of Geriatrics, Zhejiang Hospital, Hangzhou, Zhejiang, China.
Department of Rehabilitation Medicine, Zhejiang Hospital, Hangzhou, Zhejiang, China.
BMJ Open. 2016 Sep 30;6(9):e012140. doi: 10.1136/bmjopen-2016-012140.
With a rapidly ageing population, sarcopenic obesity, defined as decreased muscle mass and function combined with increased body fat, is a complex health problem. Although sarcopenic obesity contributes to a decline in physical function and exacerbates frailty in older adults, evidence from clinical trials about the effect of exercise and nutrition on this complex syndrome in Chinese older adults is lacking.
We devised a study protocol for a single-blind randomised controlled trial. Sarcopenia is described as age-related decline in muscle mass plus low muscle strength and/or low physical performance. Obesity is defined as a percentage of body fat above the 60th centile. Ninety-two eligible participants will be randomly assigned to a control group, nutrition group, exercise group and nutrition plus exercise group to receive an 8-week intervention and 12-week follow-up. The primary outcomes will be the change in short physical performance battery scores, grip strength and 6 m usual gait speed. The secondary outcomes will include basic activities of daily living scores, instrumental activity daily living scores, body composition and body anthropometric indexes. For all main analyses, the principle of intention-to-treat will be used.
This study was approved by the medical ethics committee of Zhejiang Hospital on 25 November 2015. The study will present data targeting the clinical effects of nutrition and exercise on physical function and body composition in a Chinese older population with sarcopenic obesity. The results will help to provide important clinical evidence of the role of complex non-pharmaceutical interventions for sarcopenic obese older people. The findings of this study will be submitted to peer-reviewed medical journals for publication and presented at relevant academic conferences.
ChiCTR-IOR-15007501; Pre-results.
随着人口迅速老龄化，肌少症性肥胖是一个复杂的健康问题，其定义为肌肉量和功能下降并伴有体脂增加。尽管肌少症性肥胖会导致身体功能下降并加剧老年人的虚弱，但缺乏关于运动和营养对中国老年人这一复杂综合征影响的临床试验证据。
我们设计了一项单盲随机对照试验的研究方案。肌少症被描述为与年龄相关的肌肉量下降以及低肌肉力量和/或低身体机能。肥胖定义为体脂百分比高于第60百分位数。92名符合条件的参与者将被随机分配到对照组、营养组、运动组和营养加运动组，接受为期8周的干预和12周的随访。主要结局指标将是简短体能状况量表评分、握力和6米常规步速的变化。次要结局指标将包括日常生活基本活动评分、日常生活工具性活动评分、身体成分和身体人体测量指标。对于所有主要分析，将采用意向性分析原则。
本研究于2015年11月25日获得浙江大学医学院附属第一医院医学伦理委员会批准。该研究将呈现针对营养和运动对中国患有肌少症性肥胖的老年人群身体功能和身体成分临床影响的数据。研究结果将有助于为肌少症性肥胖老年人复杂非药物干预措施的作用提供重要临床证据。本研究结果将提交给同行评审的医学期刊发表，并在相关学术会议上展示。
ChiCTR-IOR-15007501；预结果。
