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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-02-28

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Good Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Healthy Volunteers 1

The study population consists of adult, healthy volunteers randomized into two identical groups.

Intervention: ankle first

Group Type EXPERIMENTAL

Ankle first

Intervention Type PROCEDURE

1. Brachial blood pressure on both the left and right (BBP-LR) sides is measured, as well as at the left and right ankles (BPA-LR).
2. A 15 minute walking test (WT) is performed.
3. BBP-LR and BPA-LR are re-measured.
4. 2 hours of rest.
5. BBP-LR and the blood pressure at the left and right big toes (BPT-LR) are measured.
6. WT is reperformed.
7. BBP-LR and BPT-LR are re-measured.

Healthy Volunteers 2

The study population consists of adult, healthy volunteers randomized into two identical groups.

Intervention: toe first

Group Type EXPERIMENTAL

Toe first

Intervention Type PROCEDURE

1. Brachial blood pressure on both the left and right (BBP-LR) sides is measured, as well as at the left and right big toes (BPT-LR).
2. A 15 minute walking test (WT) is performed.
3. BBP-LR and BPT-LR are re-measured.
4. 2 hours of rest.
5. BBP-LR and the blood pressure at the left and right ankles (BPA-LR) are measured.
6. WT is reperformed.
7. BBP-LR and BPA-LR are re-measured.

Interventions

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Ankle first

1. Brachial blood pressure on both the left and right (BBP-LR) sides is measured, as well as at the left and right ankles (BPA-LR).
2. A 15 minute walking test (WT) is performed.
3. BBP-LR and BPA-LR are re-measured.
4. 2 hours of rest.
5. BBP-LR and the blood pressure at the left and right big toes (BPT-LR) are measured.
6. WT is reperformed.
7. BBP-LR and BPT-LR are re-measured.

Intervention Type PROCEDURE

Toe first

1. Brachial blood pressure on both the left and right (BBP-LR) sides is measured, as well as at the left and right big toes (BPT-LR).
2. A 15 minute walking test (WT) is performed.
3. BBP-LR and BPT-LR are re-measured.
4. 2 hours of rest.
5. BBP-LR and the blood pressure at the left and right ankles (BPA-LR) are measured.
6. WT is reperformed.
7. BBP-LR and BPA-LR are re-measured.

Intervention Type PROCEDURE

Eligibility Criteria

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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.)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes