Clinical trial NCT01750944: Measurement of a Systolic Pressure Index at the Toe After a Walking Test
Official title: Validation of the Measurement of a Systolic Pressure Index at the Toe (IPSO) After a Walking Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Good Health
Keywords: Blood pressure site
Good health
Brachial blood pressure
Ankle
Toe
Walking test
Exercise
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-12-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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.)

Primary outcomes:
measure: Difference between brachial and ankle blood pressure
timeFrame: Before effort test (minute -15, day 0)
measure: Difference between brachial and ankle blood pressure
timeFrame: After effort test (minute 0, day 0)
measure: Difference between brachial and toe blood pressure
timeFrame: Before effort test (minute -15, day 0)
measure: Difference between brachial and toe blood pressure
timeFrame: After effort test (minute 0, day 0)
Secondary outcomes:
measure: Brachial blood pressure, left arm
timeFrame: Before effort test (minute -15, day 0)
measure: Brachial blood pressure, left arm
timeFrame: After effort test (minute 0, day 0)
measure: Brachial blood pressure, left arm
timeFrame: After effort test (minute 5, day 0)
measure: Brachial blood pressure, left arm
timeFrame: After effort test (minute 10, day 0)
measure: Brachial blood pressure, right arm
timeFrame: Before effort test (minute -15, day 0)
measure: Brachial blood pressure, right arm
timeFrame: After effort test (minute 0, day 0)
measure: Brachial blood pressure, right arm
timeFrame: After effort test (minute 5, day 0)
measure: Brachial blood pressure, right arm
timeFrame: After effort test (minute 10, day 0)
measure: Blood pressure, left big toe
timeFrame: Before effort test (minute -15, day 0)
measure: Blood pressure, left big toe
timeFrame: After effort test (minute 0, day 0)
measure: Blood pressure, left big toe
timeFrame: After effort test (minute 5, day 0)
measure: Blood pressure, left big toe
timeFrame: After effort test (minute 10, day 0)
measure: Blood pressure, right big toe
timeFrame: Before effort test (minute -15, day 0)
measure: Blood pressure, right big toe
timeFrame: After effort test (minute 0, day 0)
measure: Blood pressure, right big toe
timeFrame: After effort test (minute 5, day 0)
measure: Blood pressure, right big toe
timeFrame: After effort test (minute 10, day 0)
measure: Blood pressure, right ankle
timeFrame: Before effort test (minute -15, day 0)
measure: Blood pressure, right ankle
timeFrame: After effort test (minute 0, day 0)
measure: Blood pressure, right ankle
timeFrame: After effort test (minute 5, day 0)
measure: Blood pressure, right ankle
timeFrame: After effort test (minute 10, day 0)
measure: Blood pressure, left ankle
timeFrame: Before effort test (minute -15, day 0)
measure: Blood pressure, left ankle
timeFrame: After effort test (minute 0, day 0)
measure: Blood pressure, left ankle
timeFrame: After effort test (minute 5, day 0)
measure: Blood pressure, left ankle
timeFrame: After effort test (minute 10, day 0)
Other outcomes:
measure: Time at which the tests were performed (hh:mm)
timeFrame: Day 0
measure: The volunteer is an athlete? yes/no
timeFrame: Day 0; baseline
measure: The volunteer drank coffee before the test? yes/no
timeFrame: Day 0; baseline
measure: The volunteer is a smoker? yes/no
timeFrame: Day 0; baseline
measure: Description of treatments currently being taken
timeFrame: Day 0; baseline
Locations:
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Antonia Perez Martin, MD
role: PRINCIPAL_INVESTIGATOR
References: