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

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

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).

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Procedure: GPS recording(s) of walking capacity in PAD patients

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 Type: Observational
• Enrollment (Actual): 251

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Peripheral arterial disease patients; 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; 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.; Other Names: Ambulatory technique; Clinical routine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Collaborators: Région des Pays de la Loire
• Investigators: Principal Investigator: Pierre Abraham, MD, PhD, University Hospital, Angers

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: June 8, 2010
• First Submitted That Met QC Criteria: June 9, 2010
• First Posted (Estimate): June 10, 2010

Study Record Updates

• Last Update Posted (Estimate): March 18, 2013
• Last Update Submitted That Met QC Criteria: March 15, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Claudication; Artery; GPS; Ambulatory technique
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: POST-GPS