Locomotion and Global Positioning System in Arterial Disease (Starter-GPS)
Primary Purpose
Peripheral Arterial Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Recording of GPS during a free walking in a public park
Sponsored by
About this trial
This is an interventional diagnostic trial for Peripheral Arterial Disease focused on measuring Claudication, peripheral arterial disease, Diagnosis, Exercise, Walking impairment, Disability
Eligibility 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
Sites / Locations
- Centre hospitalier universitaire
Outcomes
Primary Outcome Measures
Validate the ability of GPS to detect walking and resting bouts and to accurately estimate walking speed and distance in normal subjects.
Measurement of maximal walking distance using GPS and comparison with treadmill measurement in PAD patients.
Secondary Outcome Measures
Determine the variability of the walking capacity and its potential determinants in PAD patients.
Analyse the reliability and sensibility of GPS measurements of the walking capacity in PAD patients.
Analyse potential factors that could affect the accuracy of GPS measurements
Full Information
NCT ID
NCT00485147
First Posted
June 11, 2007
Last Updated
June 28, 2012
Sponsor
University Hospital, Angers
Collaborators
Société Française de Médecine Vasculaire
1. Study Identification
Unique Protocol Identification Number
NCT00485147
Brief Title
Locomotion and Global Positioning System in Arterial Disease
Acronym
Starter-GPS
Official Title
Study of Human Locomotion With Global Positioning System. Application to Patients With Peripheral Arterial Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
Collaborators
Société Française de Médecine Vasculaire
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Claudication, peripheral arterial disease, Diagnosis, Exercise, Walking impairment, Disability
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Recording of GPS during a free walking in a public park
Intervention Description
Analyse the clinical change after surgery from GPS measurements and compare it with laboratory measurement.
Primary Outcome Measure Information:
Title
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
Title
Measurement of maximal walking distance using GPS and comparison with treadmill measurement in PAD patients.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Determine the variability of the walking capacity and its potential determinants in PAD patients.
Time Frame
3 years
Title
Analyse the reliability and sensibility of GPS measurements of the walking capacity in PAD patients.
Time Frame
4 years
Title
Analyse potential factors that could affect the accuracy of GPS measurements
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Abraham, MD, PhD
Organizational Affiliation
Laboratory for Vascular Investigations. University Hospital. Angers. France.
Official's Role
Study Director
Facility Information:
Facility Name
Centre hospitalier universitaire
City
Angers
ZIP/Postal Code
49933
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
21931593
Citation
Noury-Desvaux B, Abraham P, Mahe G, Sauvaget T, Leftheriotis G, Le Faucheur A. The accuracy of a simple, low-cost GPS data logger/receiver to study outdoor human walking in view of health and clinical studies. PLoS One. 2011;6(9):e23027. doi: 10.1371/journal.pone.0023027. Epub 2011 Sep 13.
Results Reference
derived
PubMed Identifier
20347684
Citation
Le Faucheur A, Noury-Desvaux B, Mahe G, Sauvaget T, Saumet JL, Leftheriotis G, Abraham P. Variability and short-term determinants of walking capacity in patients with intermittent claudication. J Vasc Surg. 2010 Apr;51(4):886-92. doi: 10.1016/j.jvs.2009.10.120.
Results Reference
derived
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Locomotion and Global Positioning System in Arterial Disease
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