Reproducibility of Ankle Brachial Index After Maximal Exercise (RICATEM)

Reproducibility of the Ankle-Brachial Index Measurements After a Maximal Exercise

Hemodynamic changes in the lower limbs are very important and rapid after maximal exercise. The automatic method allows a fastest measurement of the Ankle-Brachial Index (ABI). Thus, it appears important to know whether automatic assessment of ABI is as reliable and reproducible as the manual method.

Study Overview

• Status: Completed
• Conditions: Normal Subjects

Detailed Description

Two methods are mainly used to determine the blood pressure at rest, in a non-invasive way, in order to calculate the Ankle-Brachial Index (ABI). The first method, using a manual sphygmomanometer coupled with a Doppler probe, is considered as the reference method. The second method requires at least one automatic sphygmomanometer. Data from the literature show that these two methods are reproducible to assess ABI at rest. Some authors have reported a better reproducibility of measurements with automatic tool. Others consider that the current accuracy of automatic measurement is insufficient to replace the reference method Doppler. Thus, the aime of the present study is to evaluate whether automatic assessment of ABI is as reliable and reproducible as the manual method.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

health volunteers over 18 years old

Description

Inclusion Criteria:

• Participant between 18 and 40 years old
• Informed consent signed
• Exclusion Criteria:
• Do not want to participate to the protocol
• Pregnant woman
• Adults to enhanced protection, deprived of their liberty by judicial or administrative authority, without consent hospitalized or admitted to a health facility or social purposes other than research
• Being in a period of exclusion from another biomedical study
• Amputee or with a member dysgenesis
• Not allowed to perform a maximal exercise

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test-retest difference in ankle to brachial pressure index	Comparison of differendces observed on test-retest measures with manual and automatic measurements	up to 2 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of recordings.	Comaprison of the time needed to complete the recording with automatic vs. manual techniques	up to 2 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Collaborators: Institut de Formation en Education Physique et en Sport d'Angers/Les Ponts de Cé
• Investigators: Principal Investigator: Antoine BRUNEAU, MD, University Hospital, Angers

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: February 18, 2013
• First Submitted That Met QC Criteria: February 26, 2013
• First Posted (Estimate): March 1, 2013

Study Record Updates

• Last Update Posted (Estimate): February 12, 2016
• Last Update Submitted That Met QC Criteria: February 11, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Ankle Brachial Index; Maximal exercise
• Other Study ID Numbers: 2012-A01036-37

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No