Feasibility of Home-based Measurement of Walking Capacity Using Global Positioning System in Peripheral Artery Disease

Study Overview
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Brief Summary
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The purpose of this study is to assess the feasibility of home-based measurement of walking capacity in peripheral arterial disease (PAD) patients, uing the Global Positioning System (GPS). This study should state if the GPS technique could be used in clinical routine in order to assess walking capacity in PAD patients. Patients will be assessed a first time (test 1) and six months later (test 2).

Detailed Description
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The measurement of walking capacity in PAD patients is an important step in the management of such patients. The gold standard method to assess this walking capacity is the measurement of the maximal walking distance on a treadmill. However, treadmill measurement are not readily accessible and the relationship with free-living walking capacity is, although not well known, weak. A novel approach was developed using a Global Positioning System in order to assess community-based walking capacity. This method showed interesting results, validating the technique, but was limited to one laboratory and to the place where the measurements were performed. The next step is therefore to assess the feasibility of home-based measurement of walking capacity using the GPS technique, through a multicenter study regrouping university hospitals, independent vascular specialists (angiologists) and private clinic(s).

Official Title
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Feasibility of Home-based Measurement of Walking Capacity Using Global Positioning System in Patients With Peripheral Arterial Disease

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Procedure: GPS recording(s) of walking capacity in PAD patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ABI < 0.90 or patients with vascular history (surgery, endovascular treatment) and having vascular type claudication Older than 18 years Vascular-type claudication (defined by the Leriche classification and the Edimbourg questionnaire criterion) Informed consent of the patient Non-Inclusion Criteria: No informed consent of the patient Exercise (walking) limitation other than vascular explained limitation Critical limb ischemia (Leriche stage 3 or 4) Major cardiovascular events in the last 3 months Pregnant woman Patient unable to understand the protocol of the study Exclusion Criteria: Withdrawal of the informed consent of the patient following the inclusion period Emergence of a non-inclusion criteria during the inclusion period Patient with a GPS maximal walking distance > 2000 meters following the first evaluation (can not be considered as having a major walking limitation)

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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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Peripheral arterial disease patients<br>Patients with a peripheral arterial disease, defined by an ankle to brachial index below 0.90 | Procedure: GPS recording(s) of walking capacity in PAD patients<br>* Home-based GPS recording(s) of walking capacity in PAD patients. Two evaluations will be performed. The second evaluation will be performed six months after the initial assessment (test 1) and only for patients with GPS maximal walking distance below 2000 meters at test 1. It is expected that some patients at test 2 will have undergo surgery or endovascular treatment.<br>* Other names: Clinical routine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of home-based GPS recordings that are analyzable |  | December 2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical quality of recorded GPS signals |  | December 2011 | 
| Easiness of the interpretation of the GPS measurements |  | December 2011 | 
| Adherence of the patients to the protocol |  | December 2011 | 
| Compare GPS results to the results obtained with different questionnaires (external validity) | The questionnaires used assess the physical activity level, the quality of life and the walking impairment of the studied PAD patients. | December 2011 | 
| Sensibility of GPS measurements after (or not) a therapeutic treatment (endovascular treatment, surgery) |  | December 2011 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Claudication, Artery, Ambulatory technique, GPS