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

Good Health Clinical Trial

— IPSO FACTO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01750944
• Other study ID #: LOCAL/2012/APM-02
• Secondary ID: 2012-A01432-41
• Status: Completed
• Phase: N/A
• First received: December 13, 2012
• Last updated: March 25, 2015
• Start date: July 2013
• Est. completion date: February 2014

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Good Health

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time at which the tests were performed (hh:mm)		Day 0	No
Other	The volunteer is an athlete? yes/no		Day 0; baseline	No
Other	The volunteer drank coffee before the test? yes/no		Day 0; baseline	No
Other	The volunteer is a smoker? yes/no		Day 0; baseline	No
Other	Description of treatments currently being taken		Day 0; baseline	No
Primary	Difference between brachial and ankle blood pressure		Before effort test (minute -15, day 0)	No
Primary	Difference between brachial and ankle blood pressure		After effort test (minute 0, day 0)	No
Primary	Difference between brachial and toe blood pressure		Before effort test (minute -15, day 0)	No
Primary	Difference between brachial and toe blood pressure		After effort test (minute 0, day 0)	No
Secondary	Brachial blood pressure, left arm		Before effort test (minute -15, day 0)	No
Secondary	Brachial blood pressure, left arm		After effort test (minute 0, day 0)	No
Secondary	Brachial blood pressure, left arm		After effort test (minute 5, day 0)	No
Secondary	Brachial blood pressure, left arm		After effort test (minute 10, day 0)	No
Secondary	Brachial blood pressure, right arm		Before effort test (minute -15, day 0)	No
Secondary	Brachial blood pressure, right arm		After effort test (minute 0, day 0)	No
Secondary	Brachial blood pressure, right arm		After effort test (minute 5, day 0)	No
Secondary	Brachial blood pressure, right arm		After effort test (minute 10, day 0)	No
Secondary	Blood pressure, left big toe		Before effort test (minute -15, day 0)	No
Secondary	Blood pressure, left big toe		After effort test (minute 0, day 0)	No
Secondary	Blood pressure, left big toe		After effort test (minute 5, day 0)	No
Secondary	Blood pressure, left big toe		After effort test (minute 10, day 0)	No
Secondary	Blood pressure, right big toe		Before effort test (minute -15, day 0)	No
Secondary	Blood pressure, right big toe		After effort test (minute 0, day 0)	No
Secondary	Blood pressure, right big toe		After effort test (minute 5, day 0)	No
Secondary	Blood pressure, right big toe		After effort test (minute 10, day 0)	No
Secondary	Blood pressure, right ankle		Before effort test (minute -15, day 0)	No
Secondary	Blood pressure, right ankle		After effort test (minute 0, day 0)	No
Secondary	Blood pressure, right ankle		After effort test (minute 5, day 0)	No
Secondary	Blood pressure, right ankle		After effort test (minute 10, day 0)	No
Secondary	Blood pressure, left ankle		Before effort test (minute -15, day 0)	No
Secondary	Blood pressure, left ankle		After effort test (minute 0, day 0)	No
Secondary	Blood pressure, left ankle		After effort test (minute 5, day 0)	No
Secondary	Blood pressure, left ankle		After effort test (minute 10, day 0)	No