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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01750944
Acronym
IPSO FACTO
Enrollment
50
Registered
2012-12-17
Start date
2013-07-31
Completion date
2014-02-28
Last updated
2015-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Good Health

Keywords

Blood pressure site, Good health, Brachial blood pressure, Ankle, Toe, Walking test, Exercise

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

Interventions

PROCEDUREAnkle 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.

PROCEDUREToe 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.

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.)

Design outcomes

Primary

MeasureTime frame
Difference between brachial and ankle blood pressureBefore effort test (minute -15, day 0)
Difference between brachial and toe blood pressureBefore effort test (minute -15, day 0)

Secondary

MeasureTime frame
Brachial blood pressure, right armBefore effort test (minute -15, day 0)
Brachial blood pressure, left armBefore effort test (minute -15, day 0)
Blood pressure, left big toeBefore effort test (minute -15, day 0)
Blood pressure, right big toeBefore effort test (minute -15, day 0)
Blood pressure, right ankleBefore effort test (minute -15, day 0)
Blood pressure, left ankleBefore effort test (minute -15, day 0)

Other

MeasureTime frame
The volunteer is an athlete? yes/noDay 0; baseline
The volunteer drank coffee before the test? yes/noDay 0; baseline
The volunteer is a smoker? yes/noDay 0; baseline
Description of treatments currently being takenDay 0; baseline
Time at which the tests were performed (hh:mm)Day 0

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026