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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01750944
First received: December 13, 2012
Last updated: March 3, 2014
Last verified: March 2014
  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 ]

Enrollment: 50
Study Start Date: July 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (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

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, France, 30029
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: March 3, 2014
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 April 16, 2014