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

Peripheral Artery Disease Clinical Trial

— POST-GPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01141361
• Other study ID #: POST-GPS
• Status: Completed
• Phase: N/A
• First received: June 8, 2010
• Last updated: March 15, 2013
• Start date: July 2009
• Est. completion date: February 2013

Study information

• Verified date: March 2013
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Procedure:
• GPS 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.

Locations

Country	Name	City	State
France	University Hospital	Angers

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Angers	Région des Pays de la Loire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of home-based GPS recordings that are analyzable		December 2011	No
Secondary	"Technical quality" of recorded GPS signals		December 2011	No
Secondary	Easiness of the interpretation of the GPS measurements		December 2011	No
Secondary	Adherence of the patients to the protocol		December 2011	No
Secondary	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	No
Secondary	Sensibility of GPS measurements after (or not) a therapeutic treatment (endovascular treatment, surgery)		December 2011	No