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Locomotion and Global Positioning System in Arterial Disease (Starter-GPS)

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ClinicalTrials.gov Identifier: NCT00485147
Recruitment Status : Completed
First Posted : June 12, 2007
Last Update Posted : July 2, 2012
Sponsor:
Collaborator:
Société Française de Médecine Vasculaire
Information provided by (Responsible Party):
University Hospital, Angers

Study Description
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Brief Summary:
The maximal walking distance (MWD) performed on treadmill (TT) remains the gold standard in estimating the walking capacity of patients suffering from peripheral arterial disease (PAD) with intermittent claudication, although treadmills are not accessible to most physicians. We hypothesized that global positioning system (GPS) recordings could monitor community-based outdoor walking and provide valid information on walking capacity in PAD patients.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Procedure: Recording of GPS during a free walking in a public park Not Applicable

Detailed Description:

The study has two main objectives, conducted together. Each objective include several phases.

Objective 1: technical validation of GPS measurements in healthy subjects.

phase 1: technical validation of a GPS device to study outdoor walking (completed).

phase 2: comparison and use of various GPS devices (intra- and inter-GPS variability) in the study outdoor walking (on-going).

phase 3: study of several factors that could influence accuracy of GPS measurements as walking speed, environment, sampling frequency and others technical features as the WAAS/EGNOS function (on-going).

Objective 2: Application in PAD patients to study walking capacity under free-living conditions

phase 1: comparison of GPS measurements (maximal walking distance) with the gold standard treadmill measurement of maximal walking distance (completed).

phase 2: analysis of the variability of the walking capacity under free-living conditions from GPS measurements (completed).

phase 3: study of reliability and sensibility (effect of treatment) of GPS measurements (on-going).

phase 4: study of the relationship between laboratory measurements of walking capacity and GPS-derived parameters.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study of Human Locomotion With Global Positioning System. Application to Patients With Peripheral Arterial Disease
Study Start Date : March 2006
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

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U.S. FDA Resources

Arms and Interventions
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Intervention Details:
    Procedure: Recording of GPS during a free walking in a public park
    Analyse the clinical change after surgery from GPS measurements and compare it with laboratory measurement.

Outcome Measures
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Primary Outcome Measures :
  1. Validate the ability of GPS to detect walking and resting bouts and to accurately estimate walking speed and distance in normal subjects. [ Time Frame: 2 years ]
  2. Measurement of maximal walking distance using GPS and comparison with treadmill measurement in PAD patients. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Determine the variability of the walking capacity and its potential determinants in PAD patients. [ Time Frame: 3 years ]
  2. Analyse the reliability and sensibility of GPS measurements of the walking capacity in PAD patients. [ Time Frame: 4 years ]
  3. Analyse potential factors that could affect the accuracy of GPS measurements [ Time Frame: 4 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ankle to Brachial Index (ABI) < 0.95 for PAD patients
  • Age > 18 years old
  • Able to walk on treadmill

Exclusion Criteria:

  • limb pain of potential non-vascular origin
  • myocardial infraction in the last six months
  • uncontrolled angina pectoris
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00485147


Locations
France
Centre hospitalier universitaire
Angers, France, 49933
Sponsors and Collaborators
University Hospital, Angers
Société Française de Médecine Vasculaire
Investigators
Study Director: Pierre Abraham, MD, PhD Laboratory for Vascular Investigations. University Hospital. Angers. France.
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT00485147     History of Changes
Other Study ID Numbers: CP 2005-04
First Posted: June 12, 2007    Key Record Dates
Last Update Posted: July 2, 2012
Last Verified: April 2010

Keywords provided by University Hospital, Angers:
Claudication
peripheral arterial disease
Diagnosis
 Exercise
Walking impairment
Disability

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