Locomotion and Global Positioning System in Arterial Disease

NCT ID: NCT00485147

Last Updated: 2012-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2010-12-31

Brief Summary

The maximal walking distance (MWD) performed on treadmill (TT) remains the gold standard in estimating the walking capacity of patients suffering from peripheral arterial disease (PAD) with intermittent claudication, although treadmills are not accessible to most physicians. We hypothesized that global positioning system (GPS) recordings could monitor community-based outdoor walking and provide valid information on walking capacity in PAD patients.

Detailed Description

The study has two main objectives, conducted together. Each objective include several phases.

Objective 1: technical validation of GPS measurements in healthy subjects.

phase 1: technical validation of a GPS device to study outdoor walking (completed).

phase 2: comparison and use of various GPS devices (intra- and inter-GPS variability) in the study outdoor walking (on-going).

phase 3: study of several factors that could influence accuracy of GPS measurements as walking speed, environment, sampling frequency and others technical features as the WAAS/EGNOS function (on-going).

Objective 2: Application in PAD patients to study walking capacity under free-living conditions

phase 1: comparison of GPS measurements (maximal walking distance) with the gold standard treadmill measurement of maximal walking distance (completed).

phase 2: analysis of the variability of the walking capacity under free-living conditions from GPS measurements (completed).

phase 3: study of reliability and sensibility (effect of treatment) of GPS measurements (on-going).

phase 4: study of the relationship between laboratory measurements of walking capacity and GPS-derived parameters.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Recording of GPS during a free walking in a public park

Analyse the clinical change after surgery from GPS measurements and compare it with laboratory measurement.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Ankle to Brachial Index (ABI) < 0.95 for PAD patients
• Age > 18 years old
• Able to walk on treadmill

Exclusion Criteria

• limb pain of potential non-vascular origin
• myocardial infraction in the last six months
• uncontrolled angina pectoris

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Société Française de Médecine Vasculaire

UNKNOWN

Sponsor Role: collaborator

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Abraham, MD, PhD

Role: STUDY_DIRECTOR

Laboratory for Vascular Investigations. University Hospital. Angers. France.

Locations

Centre hospitalier universitaire

Angers, , France

Countries

France

References

Noury-Desvaux B, Abraham P, Mahe G, Sauvaget T, Leftheriotis G, Le Faucheur A. The accuracy of a simple, low-cost GPS data logger/receiver to study outdoor human walking in view of health and clinical studies. PLoS One. 2011;6(9):e23027. doi: 10.1371/journal.pone.0023027. Epub 2011 Sep 13.

Reference Type: DERIVED

PMID: 21931593 (View on PubMed)

Le Faucheur A, Noury-Desvaux B, Mahe G, Sauvaget T, Saumet JL, Leftheriotis G, Abraham P. Variability and short-term determinants of walking capacity in patients with intermittent claudication. J Vasc Surg. 2010 Apr;51(4):886-92. doi: 10.1016/j.jvs.2009.10.120.

Reference Type: DERIVED

PMID: 20347684 (View on PubMed)

Other Identifiers

CP 2005-04

Identifier Type: -

Identifier Source: org_study_id