Peripheral Arterial DiseaseStarter-GPSNCT00485147
Locomotion and Global Positioning System in Arterial Disease
A study testing Recording of GPS during a free walking in a public park in people with Peripheral Arterial Disease, run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Recording of GPS during a free walking in a public park
- Type of treatment
- Surgery or procedure
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2006to Dec 2010
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ankle to Brachial Index (ABI) < 0.95 for PAD patients
- Age > 18 years old
- Able to walk on treadmill
Who cannot join
- limb pain of potential non-vascular origin
- myocardial infraction in the last six months
- uncontrolled angina pectoris
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Human Locomotion With Global Positioning System. Application to Patients With Peripheral Arterial Disease
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.
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Recording of GPS during a free walking in a public park
- Keywords
- Claudication, peripheral arterial disease, Diagnosis, Exercise, Walking impairment, Disability
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication, Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recording of GPS during a free walking in a public parkProcedure or surgery
Analyse the clinical change after surgery from GPS measurements and compare it with laboratory measurement.
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate the ability of GPS to detect walking and resting bouts and to accurately estimate walking speed and distance in normal subjects.
Measured: 2 years
Measurement of maximal walking distance using GPS and comparison with treadmill measurement in PAD patients.
Measured: 2 years
Secondary outcomes (3)
Determine the variability of the walking capacity and its potential determinants in PAD patients.
Measured: 3 years
Analyse the reliability and sensibility of GPS measurements of the walking capacity in PAD patients.
Measured: 4 years
Analyse potential factors that could affect the accuracy of GPS measurements
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2007 (estimated)
- Study startMar 2006
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- Société Française de Médecine Vasculaire
- Responsible party
- Sponsor
- Investigators
- Pierre Abraham, MD, PhD, Study director, Laboratory for Vascular Investigations. University Hospital. Angers. France.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00485147
- Sponsor's protocol ID
- CP 2005-04
- Acronym
- Starter-GPS
- Status last verified
- Apr 2010
- First submitted
- 11 Jun 2007
- Last updated
- 2 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21931593Le 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.
PubMed 20347684