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
  Purpose

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).


Condition Intervention
Peripheral Artery Disease
Procedure: GPS recording(s) of walking capacity in PAD patients

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Feasibility of Home-based Measurement of Walking Capacity Using Global Positioning System in Patients With Peripheral Arterial Disease

Resource links provided by NLM:


Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • Percentage of home-based GPS recordings that are analyzable [ Time Frame: December 2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • "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 ]

Enrollment: 251
Study Start Date: July 2009
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01141361

Locations
France
University Hospital
Angers, France, 49933
Sponsors and Collaborators
University Hospital, Angers
Région des Pays de la Loire
Investigators
Principal Investigator: Pierre Abraham, MD, PhD University Hospital, Angers
  More Information

No publications provided

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01141361     History of Changes
Other Study ID Numbers: POST-GPS
Study First Received: June 8, 2010
Last Updated: March 15, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Angers:
Claudication
Artery
Ambulatory technique
GPS

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 14, 2014