Measurement of a Systolic Pressure Index at the Toe After a Walking Test (IPSO FACTO)

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

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.

Study Overview

• Status: Completed
• Conditions: Good Health
• Intervention / Treatment: Procedure: Ankle first; Procedure: Toe first

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes Cedex 09, France, 30029
    • CHU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Volunteers 1; The study population consists of adult, healthy volunteers randomized into two identical groups. Intervention: ankle first	Procedure: Ankle first; 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.
Experimental: Healthy Volunteers 2; The study population consists of adult, healthy volunteers randomized into two identical groups. Intervention: toe first	Procedure: Toe first; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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)

Other Outcome Measures

Outcome Measure	Time Frame
Time at which the tests were performed (hh:mm)	Day 0
The volunteer is an athlete? yes/no	Day 0; baseline
The volunteer drank coffee before the test? yes/no	Day 0; baseline
The volunteer is a smoker? yes/no	Day 0; baseline
Description of treatments currently being taken	Day 0; baseline

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: December 13, 2012
• First Submitted That Met QC Criteria: December 13, 2012
• First Posted (Estimate): December 17, 2012

Study Record Updates

• Last Update Posted (Estimate): March 26, 2015
• Last Update Submitted That Met QC Criteria: March 25, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Exercise; Ankle; Walking test; Blood pressure site; Good health; Brachial blood pressure; Toe
• Additional Relevant MeSH Terms: Heart Murmurs; Systolic Murmurs
• Other Study ID Numbers: LOCAL/2012/APM-02; 2012-A01432-41 (Other Identifier: RCB number)