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

Completed

• Conditions: Peripheral Artery Disease

• Registration Number: NCT01141361
• Lead Sponsor: University Hospital, Angers

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).

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2010-06-08
• Study First Submitted QC: 2010-06-09
• Study First Posted: 2010-06-10
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-15
• Last Update Posted: 2013-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of home-based GPS recordings that are analyzable	December 2011

Secondary Outcome Measures

Name	Time	Method
"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

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Angers, France