Reproducibility of Ankle Brachial Index After Maximal Exercise

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01801579

Acronym

RICATEM

Enrollment

Registered

2013-03-01

Start date

2012-11-30

Completion date

2014-04-30

Last updated

2016-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Subjects

Keywords

Ankle Brachial Index, Maximal exercise

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

France

Outcome results