Effect of Whole-body Electromyostimulation (WB-EMS) and/or Protein Supplementation on Sarcopenic Obesity in Community Dwelling Males 70+ With Sarcopenic Obesity
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change of Sarcopenia Z-Score
研究概览
简要总结
The aim of the study is to determine the effect of 16 weeks of Whole Body-Electromyostimulation (WB-EMS) and/or protein supplementation on Sarcopenic Obesity (SO) in community dwelling male subjects 70+ with SO .
108 eligible men will be randomly assigned to either a (1) WB-EMS and Protein (2) Protein (3) sedentary control group.
WB-EMS will be applied 1,5 x 20 min per week (i.e. 3 sessions in two weeks) with bipolar current, 85 Hz in an intermitted mode (4 s - 4 s of rest). Protein supplementation will be adjusted to dietary intake in order to reach a total protein intake between 1,5 - 1,7g/kg body-mass/d . Primary study endpoint will be the Sarcopenia Z-Score
详细描述
The aim of the study is to evaluate the effects of Whole-Body Electromyostimulation (WB-EMS) with additional protein supplementation on Sarcopenic Obesity parameters in independently living men 70 years and older with sarcopenic obesity. The randomized controlled study compares three groups with 36 subjects each: (1) WB-EMS with additional protein supplementation, (2) protein-only and (3) passive control group, over a period of 16 weeks of WB-EMS -training. Group (1) conducts 1.5-times/week a 20 minute-sessions of WB-EMS with additional protein, group (2) is limited to protein supplementation (only) and group (3) is constrained to maintain their habitual living behavior and physical activity. Based on an individual nutrition analysis the protein intake will be adjusted to 1.5-1.7 g/kg/ bodymass/d. All groups will be supplemented with a maximum of 800 IE Vitamin D.
Primary study endpoint will be changes of the Sarcopenia Z-Score with skeletal muscle mass assessed via bio-impedance analysis (BIA). Secondary study endpoints are changes of Obesity (i.e. body-fat as assessed via BIA), cardiometabolic risk (i.e. Metabolic Syndrome Z-Score), strength parameters evaluated via Dr. Wolff BackCheck and Physiomed LegPress, quality of life (SF-12) and functional disability (late life physical disability index).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •community dwelling, independent living men
- •Sarcopenia
- •Obesity (body fat >=25%)
排除标准
- •exclusion criteria for WB-EMS-application (e.g. cardiac pacemaker)
- •diseases/medication that affect the study endpoints (e.g. Glucocorticoids >5mg/d)
- •absence of more than 2 weeks during the study period
结局指标
主要结局
Change of Sarcopenia Z-Score
时间窗: Change from Baseline Sarcopenia Z-Score at 16 weeks
ie. Z-Score generated by skeletal muscle index, gait speed and grip-strength according to the Sarcopenia Definition of the European Working Group on Sarcopenia in Older People
Change of Obesity
时间窗: Change from Baseline Obesity at 16 weeks
Assessment of body fat content and body mass index
次要结局
- Change of Quality of Life(Change from Baseline Quality of life at 16 weeks)
- Change of Physical Disability(Change from Baseline Physical Disability at 16 weeks)
- Change of Metabolic Syndrome Z-Score(Change from Baseline Metabolic Syndrome Z-Score at 16 weeks)
- Change of Back Extensors Strength(Change from Baseline Back Extensors Strength at 16 weeks)
- Change of isokinetic leg strength(Change from Baseline isokinetic leg strength at 16 weeks)