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临床试验/NCT06714565
NCT06714565招募中不适用

The Value of Near-infrared Spectroscopy and Blood Pressure Measurements in Estimating Future Fall Risk in Older Adults

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2024年12月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
141
试验地点
1
主要终点
Falls during follow-up

研究概览

简要总结

The investigators aim to study which measurements/definitions from continuous blood pressures measurements (using a Finometer) and from cerebral oxygenation measurements (using near-infrared spectroscopy (NIRS)) are associated with future fall incidents in older adults at risk of falls.

详细描述

Patients aged 65 years and over with a fall in the last 12 months are eligible for inclusion. After being informed about the study, all participants giving written informed consent will perform the active stand procedure (5min lying, 5 min standing). The hemodynamic measurements that will be performed during this procedure simultaneously consist of:

  1. Volume-clamp photoplethysmography on the finger in the digital artery (Finapres medical systems, Enschede, The Netherlands) for continuous blood pressure measurements.
  2. PortaLite MKII (Artinis medical systems, Elst, The Netherlands) for continuous cerebral oximetry (NIRS).

After completing the measurements, participants will receive a falls calendar and will be instructed to record falls, fall-related injuries, and fall-related healthcare use on a weekly basis for 12 months.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • 65 years or older
  • History of a fall (in the past year)
  • Ability to perform supine-to-stand manoeuvres.
  • Ability to sign informed consent.
  • a Mini-Mental State Examination (MMSE) score of 21 points or higher or a Montreal Cognitive Assessment (MOCA) - Dutch score of 16 points or higher.
  • Sufficient command of the Dutch language

排除标准

  • Physically not able to perform sit-to-stand and supine-to-stand manoeuvres.
  • Estimated life expectancy of less than one year.

结局指标

主要结局

Falls during follow-up

时间窗: From enrollment to 12 months follow-up

Falls data prospectively collected using fall calenders.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. dr. Nathalie van der Velde

Prof.

University of Amsterdam

研究点 (1)

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