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临床试验/NCT02206633
NCT02206633已完成不适用

The Validity of Ultrasound Velocity to Assess Hydration Status of Elderly Residing in Assisted Living Facilities

Artann Laboratories1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
73
试验地点
1
主要终点
To observe statistically significant changes in ultrasound velocity associated with normal daily variation of the individual hydration level of elderly

研究概览

简要总结

The study will aim to determine normal daily variation of the individual hydration level in longitudinal study on elderly in assisted living facility and assess a range of variation of individual hydration baselines for elderly in a normal physiologically hydrated state.

详细描述

The subject pool will be comprised of 100 elderly (over 65 years old), male and female subjects who are residing in assisted living center. All subjects will provide written informed consent before participation. For the day prior testing and all testing days subjects will be encouraged to follow standard hydration guidelines for older adults by consuming 1200-2400 ml/day depending upon the body weight of subjects. The application of the HM will follow specific protocol based on the prototype HM user manual for specific anatomic locations. Triplicate measurements will be made for each time-point. All subjects will also be measured for bioelectrical impedance analysis (BIA) and estimation of total body water using a leg-to-leg BIA machine. To examine within-day and between-day variability and reliability of the HM a subgroup (N=25) of the 100 initial subjects will be selected. Within-day reliability will be evaluated by taking multiple measurements (3) during the day. Between-day reliability will include measurements (same time) for three consecutive days for the subgroup of 25 subjects. BIA measures will also be included during each of the time points for both within-day and between-day.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

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

入选标准

  • elderly ( above 65 years old)
  • male and female subjects who is residing in assisted living centers

排除标准

  • Open wounds or rashes on calf testing area
  • Visibly detectable edema
  • Active skin infection
  • Subjects will be excluded from the study if they can't physically stand on both feet without assistance

结局指标

主要结局

To observe statistically significant changes in ultrasound velocity associated with normal daily variation of the individual hydration level of elderly

时间窗: 1 day

次要结局

未报告次要终点

研究者

发起方
Artann Laboratories
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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