Locomotion and Global Positioning System in Arterial Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Study of Human Locomotion With Global Positioning System. Application to Patients With Peripheral Arterial Disease

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Procedure: Recording of GPS during a free walking in a public park


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validate the ability of GPS to detect walking and resting bouts and to accurately estimate walking speed and distance in normal subjects. |  | 2 years | 
| Measurement of maximal walking distance using GPS and comparison with treadmill measurement in PAD patients. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the variability of the walking capacity and its potential determinants in PAD patients. |  | 3 years | 
| Analyse the reliability and sensibility of GPS measurements of the walking capacity in PAD patients. |  | 4 years | 
| Analyse potential factors that could affect the accuracy of GPS measurements |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Claudication, peripheral arterial disease, Diagnosis, Exercise, Walking impairment, Disability