Clinical trial NCT01141361: Feasibility of Home-based Measurement of Walking Capacity Using Global Positioning System in Peripheral Artery Disease
Official title: Feasibility of Home-based Measurement of Walking Capacity Using Global Positioning System in Patients With Peripheral Arterial Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Artery Disease
Keywords: Claudication
Artery
Ambulatory technique
GPS
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: Région des Pays de la Loire
First posted: 2010-06-10
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with peripheral arterial disease, defined by an ankle to brachial index below 0.90, or patients with vascular history and having vascular claudication

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of home-based GPS recordings that are analyzable
timeFrame: December 2011
Secondary outcomes:
measure: "Technical quality" of recorded GPS signals
timeFrame: December 2011
measure: Easiness of the interpretation of the GPS measurements
timeFrame: December 2011
measure: Adherence of the patients to the protocol
timeFrame: December 2011
measure: Compare GPS results to the results obtained with different questionnaires (external validity)
timeFrame: December 2011
measure: Sensibility of GPS measurements after (or not) a therapeutic treatment (endovascular treatment, surgery)
timeFrame: December 2011
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Angers
name: Pierre Abraham, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gernigon M, Le Faucheur A, Fradin D, Noury-Desvaux B, Landron C, Mahe G, Abraham P. Global positioning system use in the community to evaluate improvements in walking after revascularization: a prospective multicenter study with 6-month follow-up in patients with peripheral arterial disease. Medicine (Baltimore). 2015 May;94(18):e838. doi: 10.1097/MD.0000000000000838.