Effects of Whole-Body Electromyostimulation on Osteoporosis and Sarcopenia in Independently Living, Frail Elderly Females
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Bone Mineral Density at the lumbar spine and femoral neck region
研究概览
简要总结
Although there is some evidence that whole body electromyostimulation(WB-EMS) affect bone via its acute and longitudinal effects on muscle mass and strength, the corresponding impact on bone density and falls in older adults has not been assessed yet. The investigators hypothesize that WB-EMS significantly affects bone parameters as assessed by DXA, and significantly reduce fall rate and ratio in a cohort of frail elderly women.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 99 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female gender
- •70 years and older
- •osteopenia according to WHO
- •BMI < 24 kg/m2
- •living independently in the area of Erlangen-Nurnberg
排除标准
- •medication or diseases affecting bone metabolism (including HRT)
- •> 1 hour/week of exercise
- •epilepsy, grave neurologic disturbances,
- •cardiac pacemaker, grave circulatory disorders,
- •abdomen/groin hernia,
- •tuberculosis,
- •inflammable diseases,
- •bleeding tendencies,
研究组 & 干预措施
whole-body electromyostimulation
20 min of whole-body electromyostimulation with sequences of 6 sec of current and 4 sec at 85 Hz performed during low-intensity/low amplitude movements. 3 sessions / 14 days for 12 months
干预措施: whole-body electromyostimulation (Device)
wellness control group
Low intensity, low frequency exercise that focus on well being. 1 session/week for 10 weeks. 10 blocks of exercise with intermittent periods of 100 weeks of rest
干预措施: wellness control group. (Other)
结局指标
主要结局
Bone Mineral Density at the lumbar spine and femoral neck region
时间窗: baseline - after 12 months
Bone Mineral Density as assessed by Dual Energy X-ray Absorptiometry
Falls
时间窗: throughout the 12 month study period
Fall frequency and fall related injuries as assessed by the calendar method
次要结局
- maximum strength (trunk and leg extension, grip strength)(baseline - after 12 months)
- Pain frequency and magnitude at various skeletal sites (including low back pain)(baseline - after 12 months)
研究者
Wolfgang Kemmler
Professor Dr.
University of Erlangen-Nürnberg Medical School