NCT01750944已完成不适用
Validation of the Measurement of a Systolic Pressure Index at the Toe (IPSO) After a Walking Test
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Difference between brachial and ankle blood pressure
研究概览
简要总结
The main objective of this study is to evaluate the concordance of the variation in systolic pressure indices measured at the toe and ankle after a walking test in healthy volunteers.
详细描述
Our secondary objectives are:
- to evaluate the concordance between left- and right-side measures: systolic pressure indices measured at the toe after a walking test (healthy volunteers)
- to evaluate the concordance between left- and right-side measures: systolic pressure indices measured at the ankle after a walking test (healthy volunteers)
- to evaluate the concordance of the variation in systolic pressure indices measured at the toe and ankle during the recuperation phase after a walking test (5 and 10 minutes after end of walking test) in healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject must have given his/her informed and signed consent
- •The subject must be insured or beneficiary of a health insurance plan
排除标准
- •The subject is in an exclusion period determined by a previous study
- •The subject is under judicial protection, under tutorship or curatorship
- •The subject refuses to sign the consent
- •It is impossible to correctly inform the subject
- •The subject is pregnant, parturient, or breastfeeding
- •The subject has a contraindication for a walking test
- •Presence of mediacalcose objectified by a Doppler examination of the anterior and posterior tibial arteries, performed on the test day
- •Known history of cardiovascular disease
- •Poorly controlled diabetes or hypertension
- •Neurological, muscular or rheumatic pathology contra-indicating a walking test
- •Acute transient infection (cold-rhinitis, flu, etc.)
结局指标
主要结局
Difference between brachial and ankle blood pressure
时间窗: After effort test (minute 0, day 0)
Difference between brachial and toe blood pressure
时间窗: After effort test (minute 0, day 0)
次要结局
- Blood pressure, right big toe(After effort test (minute 10, day 0))
- Blood pressure, right ankle(After effort test (minute 10, day 0))
- Brachial blood pressure, right arm(After effort test (minute 10, day 0))
- Blood pressure, left ankle(After effort test (minute 10, day 0))
- Brachial blood pressure, left arm(After effort test (minute 10, day 0))
- Blood pressure, left big toe(After effort test (minute 10, day 0))
研究者
研究点 (2)
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