RICATEM: Reproducibility of Ankle Brachial Index After Maximal Exercise

Sponsor

University Hospital, Angers (Other)

Overall Status

Completed

CT.gov ID

NCT01801579

Collaborator

Institut de formation en éducation physique et en sport d'Angers/Les Ponts de Cé (Other)

Enrollment

Location

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

15 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Nov 1, 2012

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Apr 1, 2014

Outcome Measures

Primary Outcome Measures

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

Duration of recordings. [up to 2 weeks]
Comaprison of the time needed to complete the recording with automatic vs. manual techniques

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	Angers		France	49933

Sponsors and Collaborators

University Hospital, Angers
Institut de formation en éducation physique et en sport d'Angers/Les Ponts de Cé

Investigators

Principal Investigator: Antoine BRUNEAU, MD, University Hospital, Angers

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Angers

ClinicalTrials.gov Identifier:

NCT01801579

Other Study ID Numbers:

2012-A01036-37

First Posted:

Mar 1, 2013

Last Update Posted:

Feb 12, 2016

Last Verified:

Feb 1, 2016

Keywords provided by University Hospital, Angers

Ankle Brachial Index

Maximal exercise

Study Results

No Results Posted as of Feb 12, 2016