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OpenTrials
Completed

NCT Number: NCT01801579

Reproducibility of Ankle Brachial Index After 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.

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Key information

Conditions

Normal Subjects

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital

Angers, 49933, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Test-retest difference in ankle to brachial pressure index

    Time frame: up to 2 week

    Comparison of differendces observed on test-retest measures with manual and automatic measurements

Secondary outcomes

  1. Duration of recordings.

    Time frame: up to 2 weeks

    Comaprison of the time needed to complete the recording with automatic vs. manual techniques

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Collaborators

  • Institut de formation en éducation physique et en sport d'Angers/Les Ponts de Cé

Registry information

Official study title

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

Acronym: RICATEM

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 1, 2013
Registry last updated
Feb 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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