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临床试验/NCT02089516
NCT02089516已完成不适用

Activity Monitoring in Frail Elderly Patients. A Methods Comparison Study.

Medical Research Foundation, The Netherlands2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2014年2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
18
试验地点
2
主要终点
Type of movement: lying, sitting/standing or walking

研究概览

简要总结

The purpose of this stuydy is to assess the bias and repeatability of the DynaPort MicroMod in measuring movement / physical activity in frail elderly.

详细描述

Elderly subjects will be recruited from a residential-care complex in Zwolle, the Netherlands. All subjects will be asked to fill in the Groningen Frailty Index. We aim to select patients with varying GFI scores to ensure that we include patients with different degrees of frailty. The participating subjects will be asked to wear the DynaPort MicroMod during six hours. Two research employees will observe all activities of the participating subjects in their home environment. The participant will be instructed to act like it is a normal/usual day. Every 5 minutes the type of activity at that moment and movement intensity of the last 5 minutes (METs scale) is manually entered onto a case report form (CRF) by the two employees. The timing has to be exact in order to compare the data to the data of the DynaPort MicroMod. Type of activity is described as well as categorised into lying, sitting, standing or walking. Movement intensity is categorised according to a MET-value (Metabolic Equivalent of Task).

Sensitivity, specificity, and percentage of overall agreement will be calculated for each type of activity (standing, sitting, lying, walking) and for intensity. The primary analysis will be the comparison between walking and not walking (lying, sitting or standing). An overall agreement/sensitivity/specificity of 90% or higher is considered as sufficient agreement. The Bland and Altman method will also be used as multiple observations are recorded per patient, the limits of agreement will also be calculated with the Bland and Altman method for repeated measures.

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
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age: 75 years and older
  • •Frailty: GFI (Groningen Frailty Index) score ≥ 4

排除标准

  • •Living in a nursing-home

结局指标

主要结局

Type of movement: lying, sitting/standing or walking

时间窗: up to six hours

The participating subjects will be asked to wear the DynaPort MicroMod during six hours. Two research employees will observe all activities of the participating subjects in their home environment. Every 5 minutes the type of activity at that moment is manually entered onto a case report form (CRF) by the two research employees.

次要结局

  • Movement intensity (METs)(up to six hours)

研究者

发起方
Medical Research Foundation, The Netherlands
申办方类型
Other
责任方
Principal Investigator
主要研究者

Henk Bilo, MD

MD PhD

Medical Research Foundation, The Netherlands

研究点 (2)

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