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

NCT01141361 | Completed DMC

• 1 other identifier: POST-GPS
• Study Type: observational
• Target: 251
• Locations: 1 country
• Sites: 1

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).

Conditions

Peripheral Artery Disease

Keywords

Claudication; Artery; Ambulatory technique; GPS

Outcome Measures

Primary Outcomes (1)

• Percentage of home-based GPS recordings that are analyzable

  December 2011

Secondary Outcomes (5)

• "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

• Sensibility of GPS measurements after (or not) a therapeutic treatment (endovascular treatment, surgery)

  December 2011

Study Arms (1)

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

Interventions

GPS recording(s) of walking capacity in PAD patients 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.

Also known as: Ambulatory technique, Clinical routine

Peripheral arterial disease patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Angers: lead
• Région des Pays de la Loire: collaborator

Study Sites (1)

University Hospital

Angers, 49933, France

Location

Related Publications (1)

• 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.

  PMID: 25950694 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pierre Abraham, MD, PhD

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2010
• First Posted: June 10, 2010
• Study Start: July 1, 2009
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: March 18, 2013

Record last verified: 2013-03

Locations

FR (1)