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

This study is not yet open for participant recruitment.
Verified June 2013 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01750944
First received: December 13, 2012
Last updated: June 13, 2013
Last verified: June 2013
History of Changes
  Purpose

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.


Condition Intervention
Good Health
 Procedure: Ankle first
Procedure: Toe first

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Validation of the Measurement of a Systolic Pressure Index at the Toe (IPSO) After a Walking Test

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Difference between brachial and ankle blood pressure [ Time Frame: Before effort test (minute -15, day 0) ] [ Designated as safety issue: No ]
  • Difference between brachial and ankle blood pressure [ Time Frame: After effort test (minute 0, day 0) ] [ Designated as safety issue: No ]
  • Difference between brachial and toe blood pressure [ Time Frame: Before effort test (minute -15, day 0) ] [ Designated as safety issue: No ]
  • Difference between brachial and toe blood pressure [ Time Frame: After effort test (minute 0, day 0) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Brachial blood pressure, left arm [ Time Frame: Before effort test (minute -15, day 0) ] [ Designated as safety issue: No ]
  • Brachial blood pressure, left arm [ Time Frame: After effort test (minute 0, day 0) ] [ Designated as safety issue: No ]
  • Brachial blood pressure, left arm [ Time Frame: After effort test (minute 5, day 0) ] [ Designated as safety issue: No ]
  • Brachial blood pressure, left arm [ Time Frame: After effort test (minute 10, day 0) ] [ Designated as safety issue: No ]
  • Brachial blood pressure, right arm [ Time Frame: Before effort test (minute -15, day 0) ] [ Designated as safety issue: No ]
  • Brachial blood pressure, right arm [ Time Frame: After effort test (minute 0, day 0) ] [ Designated as safety issue: No ]
  • Brachial blood pressure, right arm [ Time Frame: After effort test (minute 5, day 0) ] [ Designated as safety issue: No ]
  • Brachial blood pressure, right arm [ Time Frame: After effort test (minute 10, day 0) ] [ Designated as safety issue: No ]
  • Blood pressure, left big toe [ Time Frame: Before effort test (minute -15, day 0) ] [ Designated as safety issue: No ]
  • Blood pressure, left big toe [ Time Frame: After effort test (minute 0, day 0) ] [ Designated as safety issue: No ]
  • Blood pressure, left big toe [ Time Frame: After effort test (minute 5, day 0) ] [ Designated as safety issue: No ]
  • Blood pressure, left big toe [ Time Frame: After effort test (minute 10, day 0) ] [ Designated as safety issue: No ]
  • Blood pressure, right big toe [ Time Frame: Before effort test (minute -15, day 0) ] [ Designated as safety issue: No ]
  • Blood pressure, right big toe [ Time Frame: After effort test (minute 0, day 0) ] [ Designated as safety issue: No ]
  • Blood pressure, right big toe [ Time Frame: After effort test (minute 5, day 0) ] [ Designated as safety issue: No ]
  • Blood pressure, right big toe [ Time Frame: After effort test (minute 10, day 0) ] [ Designated as safety issue: No ]
  • Blood pressure, right ankle [ Time Frame: Before effort test (minute -15, day 0) ] [ Designated as safety issue: No ]
  • Blood pressure, right ankle [ Time Frame: After effort test (minute 0, day 0) ] [ Designated as safety issue: No ]
  • Blood pressure, right ankle [ Time Frame: After effort test (minute 5, day 0) ] [ Designated as safety issue: No ]
  • Blood pressure, right ankle [ Time Frame: After effort test (minute 10, day 0) ] [ Designated as safety issue: No ]
  • Blood pressure, left ankle [ Time Frame: Before effort test (minute -15, day 0) ] [ Designated as safety issue: No ]
  • Blood pressure, left ankle [ Time Frame: After effort test (minute 0, day 0) ] [ Designated as safety issue: No ]
  • Blood pressure, left ankle [ Time Frame: After effort test (minute 5, day 0) ] [ Designated as safety issue: No ]
  • Blood pressure, left ankle [ Time Frame: After effort test (minute 10, day 0) ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Time at which the tests were performed (hh:mm) [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • The volunteer is an athlete? yes/no [ Time Frame: Day 0; baseline ] [ Designated as safety issue: No ]
  • The volunteer drank coffee before the test? yes/no [ Time Frame: Day 0; baseline ] [ Designated as safety issue: No ]
  • The volunteer is a smoker? yes/no [ Time Frame: Day 0; baseline ] [ Designated as safety issue: No ]
  • Description of treatments currently being taken [ Time Frame: Day 0; baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Healthy Volunteers 1

The study population consists of adult, healthy volunteers randomized into two identical groups.

Intervention: ankle first

 Procedure: Ankle 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.
Experimental: Healthy Volunteers 2

The study population consists of adult, healthy volunteers randomized into two identical groups.

Intervention: toe first

 Procedure: Toe 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750944

Contacts
Contact: Antonia Perez Martin, MD +33.(0)4.66.68.33.13 antonia.perez.martin@chu-nimes.fr
Contact: Carey Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 09, France, 30029
Principal Investigator: Antonia Perez Martin, MD            
Sub-Investigator: Isabelle Rebuffat            
Sub-Investigator: Gilles Mazel            
Sub-Investigator: Monika Di Rienzo, MD            
Sub-Investigator: Isabelle Aïchoun, MD            
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Antonia Perez Martin, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01750944     History of Changes
Other Study ID Numbers: LOCAL/2012/APM-02, 2012-A01432-41
Study First Received: December 13, 2012
Last Updated: June 13, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Blood pressure site
Good health
Brachial blood pressure
Ankle
 Toe
Walking test
Exercise

ClinicalTrials.gov processed this record on June 18, 2013