Peripheral Artery Disease
Conditions
Keywords
Claudication, Artery, Ambulatory technique, GPS
Brief summary
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
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).
Interventions
PROCEDUREGPS recording(s) of walking capacity in PAD patients
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.
Sponsors
Région des Pays de la Loire
University Hospital, Angers
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of home-based GPS recordings that are analyzable | December 2011 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | December 2011 | The questionnaires used assess the physical activity level, the quality of life and the walking impairment of the studied PAD patients. |
| Sensibility of GPS measurements after (or not) a therapeutic treatment (endovascular treatment, surgery) | December 2011 | — |
Countries
France
Outcome results
None listed