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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Human Locomotion With Global Positioning System. Application to Patients With Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT00485147
- Acronym / sponsor ID
- Starter-GPS / CP 2005-04
- Conditions
- Peripheral Arterial Disease
- Keywords
- Claudication, peripheral arterial disease, Diagnosis, Exercise, Walking impairment, Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Société Française de Médecine Vasculaire
- Study start
- Mar 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 12 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ankle to Brachial Index (ABI) < 0.95 for PAD patients
- Age > 18 years old
- Able to walk on treadmill
Key exclusion criteria (3 listed)
- limb pain of potential non-vascular origin
- myocardial infraction in the last six months
- uncontrolled angina pectoris
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recording of GPS during a free walking in a public parkAnalyse the clinical change after surgery from GPS measurements and compare it with laboratory measurement. | Procedure or surgery | – |
Primary outcome
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
Measurement of maximal walking distance using GPS and comparison with treadmill measurement in PAD patients.
Time frame: 2 years
3 secondary outcomes
Determine the variability of the walking capacity and its potential determinants in PAD patients.
Time frame: 3 years
Analyse the reliability and sensibility of GPS measurements of the walking capacity in PAD patients.
Time frame: 4 years
Analyse potential factors that could affect the accuracy of GPS measurements
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2012.
- Derived from this study: PubMed 21931593Noury-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.
- Derived from this study: PubMed 20347684Le 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Abraham, MD, PhD study director
Laboratory for Vascular Investigations. University Hospital. Angers. France.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00485147, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2012; AzTrials last refreshed its copy on 26 Oct 2026.