Reproducibility of Ankle Brachial Index After Maximal Exercise

Completed

• Conditions: Normal Subjects

• Registration Number: NCT01801579
• Lead Sponsor: University Hospital, Angers

Brief Summary

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.

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 Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-02-18
• Study First Submitted QC: 2013-02-26
• Study First Posted: 2013-03-01
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-11
• Last Update Posted: 2016-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Duration of recordings.	up to 2 weeks	Comaprison of the time needed to complete the recording with automatic vs. manual techniques

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Angers, France