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

Study Overview
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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.

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

Official Title
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Validation of the Measurement of a Systolic Pressure Index at the Toe (IPSO) After a Walking Test

Conditions
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Good Health

Intervention / Treatment
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* Procedure: Ankle first
* Procedure: Toe first


Participation Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Volunteers 1<br>The study population consists of adult, healthy volunteers randomized into two identical groups. Intervention: ankle first | Procedure: Ankle first<br>* 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). A 15 minute walking test (WT) is performed. BBP-LR and BPA-LR are re-measured. 2 hours of rest. BBP-LR and the blood pressure at the left and right big toes (BPT-LR) are measured. WT is reperformed. BBP-LR and BPT-LR are re-measured.<br>|
| Experimental: Healthy Volunteers 2<br>The study population consists of adult, healthy volunteers randomized into two identical groups. Intervention: toe first | Procedure: Toe first<br>* 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). A 15 minute walking test (WT) is performed. BBP-LR and BPT-LR are re-measured. 2 hours of rest. BBP-LR and the blood pressure at the left and right ankles (BPA-LR) are measured. WT is reperformed. BBP-LR and BPA-LR are re-measured.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between brachial and ankle blood pressure |  | Before effort test (minute -15, day 0) | 
| Difference between brachial and ankle blood pressure |  | After effort test (minute 0, day 0) | 
| Difference between brachial and toe blood pressure |  | Before effort test (minute -15, day 0) | 
| Difference between brachial and toe blood pressure |  | After effort test (minute 0, day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brachial blood pressure, left arm |  | Before effort test (minute -15, day 0) | 
| Brachial blood pressure, left arm |  | After effort test (minute 0, day 0) | 
| Brachial blood pressure, left arm |  | After effort test (minute 5, day 0) | 
| Brachial blood pressure, left arm |  | After effort test (minute 10, day 0) | 
| Brachial blood pressure, right arm |  | Before effort test (minute -15, day 0) | 
| Brachial blood pressure, right arm |  | After effort test (minute 0, day 0) | 
| Brachial blood pressure, right arm |  | After effort test (minute 5, day 0) | 
| Brachial blood pressure, right arm |  | After effort test (minute 10, day 0) | 
| Blood pressure, left big toe |  | Before effort test (minute -15, day 0) | 
| Blood pressure, left big toe |  | After effort test (minute 0, day 0) | 
| Blood pressure, left big toe |  | After effort test (minute 5, day 0) | 
| Blood pressure, left big toe |  | After effort test (minute 10, day 0) | 
| Blood pressure, right big toe |  | Before effort test (minute -15, day 0) | 
| Blood pressure, right big toe |  | After effort test (minute 0, day 0) | 
| Blood pressure, right big toe |  | After effort test (minute 5, day 0) | 
| Blood pressure, right big toe |  | After effort test (minute 10, day 0) | 
| Blood pressure, right ankle |  | Before effort test (minute -15, day 0) | 
| Blood pressure, right ankle |  | After effort test (minute 0, day 0) | 
| Blood pressure, right ankle |  | After effort test (minute 5, day 0) | 
| Blood pressure, right ankle |  | After effort test (minute 10, day 0) | 
| Blood pressure, left ankle |  | Before effort test (minute -15, day 0) | 
| Blood pressure, left ankle |  | After effort test (minute 0, day 0) | 
| Blood pressure, left ankle |  | After effort test (minute 5, day 0) | 
| Blood pressure, left ankle |  | After effort test (minute 10, day 0) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood pressure site, Good health, Brachial blood pressure, Ankle, Toe, Walking test, Exercise