Reproducibility of Ankle Brachial Index After Maximal Exercise

Normal Subjects Clinical Trial

— RICATEM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01801579
• Other study ID #: 2012-A01036-37
• Status: Completed
• Phase: N/A
• First received: February 18, 2013
• Last updated: February 11, 2016
• Start date: November 2012
• Est. completion date: April 2014

Study information

• Verified date: February 2016
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Normal Subjects

Locations

Country	Name	City	State
France	University Hospital	Angers

Sponsors (2)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Duration of recordings.	Comaprison of the time needed to complete the recording with automatic vs. manual techniques	up to 2 weeks	No