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临床试验/NCT00667667
NCT00667667终止3 期

Effect of Whole Body Vibration Training on Two Different Devices on Osteoporotic Risk Factors in Postmenopausal Women. A Randomized Controlled Trial.

University of Erlangen-Nürnberg Medical School2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2008年4月1日最近更新:
适应症

试验速览

阶段
3 期
状态
终止
发起方
入组人数
108
试验地点
2
主要终点
Bone Mineral Density

研究概览

简要总结

There is general agreement that physical exercise can positively influence osteoporotic fracture risk along two pathways: first by reducing the risk of falls via an improvement of fall related neuromuscular abilities; second by increasing bone strength.

Whole body vibration (WBV) training has recently been proposed as a new approach for prevention and treatment of osteoporosis. Animal studies have shown evidence that WBV may be an effective method to improve bone mass, architecture and strength. However, the results of human WBV training studies are rather heterogeneous.

In the Erlangen Longitudinal Vibration Study II (ELVIS II), a randomized, controlled 12 month lasting study the investigators determine the effect of a thrice weekly WBV training on two different devices on the osteoporotic risk factors: bone mineral density, falls and neuromuscular performance. Particular the investigators compare a bipedal vertical oscillating Plate with a plate which rotates around a central axis leading to a side-alternating loaning.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
60 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • females 60 - 75 years old
  • caucasian race

排除标准

  • CHD-diseases
  • thrombosis, embolism
  • fractures at lumbar spine or hip
  • secondary osteoporosis
  • hyperparathyroidism
  • medication, diseases with impact on muscle or bone
  • hip or knee implant

结局指标

主要结局

Bone Mineral Density

时间窗: Baseline, 12 months

次要结局

  • Quality of life(baseline, 12 month)
  • falls(daily over 12 month)
  • muscle strength(baseline, 12 months)

研究者

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wolfgang Kemmler

Principal Investigator

University of Erlangen-Nürnberg Medical School

研究点 (2)

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