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

NCT ID: NCT01141361

Last Updated: 2013-03-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 251 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2013-02-28

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).

Conditions

Peripheral Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Peripheral arterial disease patients

Patients with a peripheral arterial disease, defined by an ankle to brachial index below 0.90

GPS recording(s) of walking capacity in PAD patients

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Ambulatory technique; Clinical routine

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

• 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

• Patient with a GPS maximal walking distance > 2000 meters following the first evaluation (can not be considered as having a major walking limitation)

Exclusion Criteria

• Withdrawal of the informed consent of the patient following the inclusion period

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Région des Pays de la Loire

UNKNOWN

Sponsor Role: collaborator

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Abraham, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Angers

Locations

University Hospital

Angers, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 25950694 (View on PubMed)

Other Identifiers

POST-GPS

Identifier Type: -

Identifier Source: org_study_id