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临床试验/NCT02356016
NCT02356016已完成2 期

Effects of Whole-body Electromyostimulation and Dietary Supplements on "Sarcopenic Obesity" in Elderly Females Living in the Community

University of Erlangen-Nürnberg Medical School0 个研究点目标入组 75 人开始时间: 2013年8月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
75
主要终点
Muscle density of the medial thigh

研究概览

简要总结

The aim of the study is to determine the effect of whole body electromyostimulation (WB-EMS) and/or nutritional on body composition and functional tasks in elderly females with sarcopenic obesity. Seventy-five, non-sportive, independently living women 70 years and older with Sarcopenic Obesity were randomly assigned to either a WB-EMS group ( n=25), a WB-EMS/nutritional supplements (n=25) or a semi-active control group (an=25). The WB-EMS protocol applied one session of 18 min/week of WB-EMS (bipolar, 85 Hz). Nutritional strategy based on a high protein supplement.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
Female
接受健康志愿者

入选标准

  • community dwelling
  • Sarcopenic Obesity

排除标准

  • exercising more than 60 min/week
  • more than 4 weeks absent during the interventional period,
  • injuries (i.e. hip TotalEndoProsthesis (TEP), abdomen/groin hernia) or diseases (i.e. epilepsy, cardiac arrhythmia) that prevent WB-EMS intervention
  • medication and/or diseases affecting our primary endpoints.

结局指标

主要结局

Muscle density of the medial thigh

时间窗: baseline - 6 months follow-up

changes of muscle density (thigh) from baseline to 6 month follow-up

Appendicular skeletal muscle mass

时间窗: baseline - 6 months follow-up

changes of appendicular skeletal muscle mass from baseline to 6 month follow-up

Intramuscular fat content

时间窗: baseline - 6 months follow-up

changes of Intramuscular fat content (thigh) from baseline to 6 month follow-up

次要结局

  • Muscle cross sectional area (CSA)(baseline - 6 months follow-up)
  • Isokinetic leg strength(baseline - 6 months follow-up)
  • Short Physical Performance Battery (SPPB)(baseline - 6 months follow-up)
  • Hand grip of the dominant hand(baseline - 6 months follow-up)
  • muscular power of the legs(baseline - 6 months follow-up)

研究者

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other
责任方
Sponsor

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