NCT01576081已完成不适用
The Effects of a 56day Unilateral Muscular Unloading Intervention With a Novel Device That Allows Normal Ambulation While Reducing Muscle Activation Drastically, on Muscles, Bones and Vessels.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Bone density as measured with pQCT
研究概览
简要总结
The present study aimed to investigate the importance of gravitational induced forces that appear during normal ambulation for the health of muscles, bones and blood vessels. The main hypothesis of the present study is that gravitational loading alone, without muscle contractions, is insufficient to maintain bone strength.
详细描述
The 56day unloading intervention with HEPHAISTOS had the following key objectives:
- Primary objective: Assessment and evaluation of bone adaptation.
- Secondary objective: Assessment and evaluation of functional and structural muscular adaptations.
- Third objective: Assessment and evaluation of functional and structural vascular adaptations.
- Fourth objective: Assessment and evaluation if the present findings deviate from findings observed in established unloading models.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •age: 20-40 years
- •BMI: 20-30
- •passing the psychological and medical check up.
- •signed consent to participate in the study
- •faultless certificate of good conduct
排除标准
- •professional athletes
- •muscle or joint disease
- •trabecular bone density in the distal tibia epiphysis < 160mg/cm3
- •increase risk of thrombosis
- •bone fractures 12 months prior to the study
- •metal implants, any material of osteosynthesis
- •participation in another clinical intervention study 2 months prior to the study
- •bleeding disorder
- •anesthetic intolerance
- •vascular disease
- •claustrophobia
- •herniated disk
- •pacemaker
- •alcohol or drug abuse
- •anti-inflammatory drug intake during the study
- •hyperlipidemia
- •kidney disease
- •hyperhomocysteinaemia
- •vitamin d deficit
- •chronical back pain
结局指标
主要结局
Bone density as measured with pQCT
时间窗: 1 year
subjects will be followed for one year, starting from the onset of the study
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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