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

This study has been completed.
Sponsor:
Collaborator:
Région des Pays de la Loire
Information provided by (Responsible Party):
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01141361
First received: June 8, 2010
Last updated: March 15, 2013
Last verified: March 2013

June 8, 2010
March 15, 2013
July 2009
February 2013   (final data collection date for primary outcome measure)
Percentage of home-based GPS recordings that are analyzable [ Time Frame: December 2011 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01141361 on ClinicalTrials.gov Archive Site
  • "Technical quality" of recorded GPS signals [ Time Frame: December 2011 ] [ Designated as safety issue: No ]
  • Easiness of the interpretation of the GPS measurements [ Time Frame: December 2011 ] [ Designated as safety issue: No ]
  • Adherence of the patients to the protocol [ Time Frame: December 2011 ] [ Designated as safety issue: No ]
  • Compare GPS results to the results obtained with different questionnaires (external validity) [ Time Frame: December 2011 ] [ Designated as safety issue: No ]
    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) [ Time Frame: December 2011 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Feasibility of Home-based Measurement of Walking Capacity Using Global Positioning System in Peripheral Artery Disease
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).

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).

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with peripheral arterial disease, defined by an ankle to brachial index below 0.90, or patients with vascular history and having vascular claudication

Peripheral Artery Disease
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
Peripheral arterial disease patients
Patients with a peripheral arterial disease, defined by an ankle to brachial index below 0.90
Intervention: Procedure: GPS recording(s) of walking capacity in PAD patients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
251
February 2013
February 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01141361
POST-GPS
Yes
University Hospital, Angers
University Hospital, Angers
Région des Pays de la Loire
Principal Investigator: Pierre Abraham, MD, PhD University Hospital, Angers
University Hospital, Angers
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP