Clinical trial NCT00485147: Locomotion and Global Positioning System in Arterial Disease
Official title: Study of Human Locomotion With Global Positioning System. Application to Patients With Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Claudication
peripheral arterial disease
Diagnosis
Exercise
Walking impairment
Disability
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: Société Française de Médecine Vasculaire
First posted: 2007-06-12
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Validate the ability of GPS to detect walking and resting bouts and to accurately estimate walking speed and distance in normal subjects.
timeFrame: 2 years
measure: Measurement of maximal walking distance using GPS and comparison with treadmill measurement in PAD patients.
timeFrame: 2 years
Secondary outcomes:
measure: Determine the variability of the walking capacity and its potential determinants in PAD patients.
timeFrame: 3 years
measure: Analyse the reliability and sensibility of GPS measurements of the walking capacity in PAD patients.
timeFrame: 4 years
measure: Analyse potential factors that could affect the accuracy of GPS measurements
timeFrame: 4 years
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre hospitalier universitaire
Study officials:
affiliation: Laboratory for Vascular Investigations. University Hospital. Angers. France.
name: Pierre Abraham, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.