Measurement of a Systolic Pressure Index at the Toe After a Walking Test

Not Applicable

Completed

• Conditions: Good Health
• Interventions: Procedure: Toe first; Procedure: Ankle first

• Registration Number: NCT01750944
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2012-12-13
• Study First Submitted QC: 2012-12-13
• Study First Posted: 2012-12-17
• Study Start: 2013-07
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• The subject must have given his/her informed and signed consent
• The subject must be insured or beneficiary of a health insurance plan

Exclusion Criteria

• 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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers 2	Toe first	The study population consists of adult, healthy volunteers randomized into two identical groups. Intervention: toe first
Healthy Volunteers 1	Ankle first	The study population consists of adult, healthy volunteers randomized into two identical groups. Intervention: ankle first

Primary Outcome Measures

Name	Time	Method
Difference between brachial and ankle blood pressure	After effort test (minute 0, day 0)
Difference between brachial and toe blood pressure	After effort test (minute 0, day 0)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France