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临床试验/NCT01801579
NCT01801579已完成不适用

Reproducibility of the Ankle-Brachial Index Measurements After a Maximal Exercise

University Hospital, Angers1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2012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
15
试验地点
1
主要终点
Test-retest difference in ankle to brachial pressure index

研究概览

简要总结

Hemodynamic changes in the lower limbs are very important and rapid after maximal exercise. The automatic method allows a fastest measurement of the Ankle-Brachial Index (ABI). Thus, it appears important to know whether automatic assessment of ABI is as reliable and reproducible as the manual method.

详细描述

Two methods are mainly used to determine the blood pressure at rest, in a non-invasive way, in order to calculate the Ankle-Brachial Index (ABI). The first method, using a manual sphygmomanometer coupled with a Doppler probe, is considered as the reference method. The second method requires at least one automatic sphygmomanometer. Data from the literature show that these two methods are reproducible to assess ABI at rest. Some authors have reported a better reproducibility of measurements with automatic tool. Others consider that the current accuracy of automatic measurement is insufficient to replace the reference method Doppler. Thus, the aime of the present study is to evaluate whether automatic assessment of ABI is as reliable and reproducible as the manual method.

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
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participant between 18 and 40 years old
  • Informed consent signed

排除标准

  • Do not want to participate to the protocol
  • Pregnant woman
  • Adults to enhanced protection, deprived of their liberty by judicial or administrative authority, without consent hospitalized or admitted to a health facility or social purposes other than research
  • Being in a period of exclusion from another biomedical study
  • Amputee or with a member dysgenesis
  • Not allowed to perform a maximal exercise

结局指标

主要结局

Test-retest difference in ankle to brachial pressure index

时间窗: up to 2 week

Comparison of differendces observed on test-retest measures with manual and automatic measurements

次要结局

  • Duration of recordings.(up to 2 weeks)

研究者

发起方
University Hospital, Angers
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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