Peripheral Artery DiseasePOST-GPSNCT01141361
Feasibility of Home-based Measurement of Walking Capacity Using Global Positioning System in Peripheral Artery Disease
An observational study of Peripheral Artery Disease, run by University Hospital, Angers at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- GPS recording(s) of walking capacity in PAD patients
- Type of treatment
- Surgery or procedure
- How many people
- 251 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2009to Feb 2013
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Home-based Measurement of Walking Capacity Using Global Positioning System in Patients With Peripheral Arterial Disease
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).
Read the 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).
- Conditions
- Peripheral Artery Disease
- Being tested
- GPS recording(s) of walking capacity in PAD patients
- Keywords
- Claudication, Artery, Ambulatory technique, GPS
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPS recording(s) of walking capacity in PAD patientsProcedure or surgery
Also called Ambulatory technique, Clinical routine
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.
| Study group | Role | What they receive |
|---|---|---|
| Peripheral arterial disease patients | Patients with a peripheral arterial disease, defined by an ankle to brachial index below 0.90 Receives: Procedure: GPS recording(s) of walking capacity in PAD patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of home-based GPS recordings that are analyzable
Measured: December 2011
Secondary outcomes (5)
"Technical quality" of recorded GPS signals
Measured: December 2011
Easiness of the interpretation of the GPS measurements
Measured: December 2011
Adherence of the patients to the protocol
Measured: December 2011
Compare GPS results to the results obtained with different questionnaires (external validity)
The questionnaires used assess the physical activity level, the quality of life and the walking impairment of the studied PAD patients.
Measured: December 2011
Sensibility of GPS measurements after (or not) a therapeutic treatment (endovascular treatment, surgery)
Measured: December 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startJul 2009
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- Région des Pays de la Loire
- Responsible party
- Sponsor
- Investigators
- Pierre Abraham, MD, PhD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141361
- Sponsor's protocol ID
- POST-GPS
- Acronym
- POST-GPS
- Status last verified
- Mar 2013
- First submitted
- 8 Jun 2010
- Last updated
- 18 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gernigon M, Le Faucheur A, Fradin D, Noury-Desvaux B, Landron C, Mahe G, Abraham P. Global positioning system use in the community to evaluate improvements in walking after revascularization: a prospective multicenter study with 6-month follow-up in patients with peripheral arterial disease. Medicine (Baltimore). 2015 May;94(18):e838. doi: 10.1097/MD.0000000000000838.
PubMed 25950694
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Home-based Measurement of Walking Capacity Using Global Positioning System in Patients With Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT01141361
- Acronym / sponsor ID
- POST-GPS / POST-GPS
- Conditions
- Peripheral Artery Disease
- Keywords
- Claudication, Artery, Ambulatory technique, GPS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Région des Pays de la Loire
- Study start
- Jul 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 10 Jun 2010 (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 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).
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peripheral arterial disease patients | – | Procedure: GPS recording(s) of walking capacity in PAD patientsPatients with a peripheral arterial disease, defined by an ankle to brachial index below 0.90 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (11 listed)
- 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
- No informed consent of the patient
Key exclusion criteria (3 listed)
- 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)
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 |
|---|---|---|
| GPS recording(s) of walking capacity in PAD patientsAlso: Ambulatory technique, Clinical routineHome-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. | Procedure or surgery | Peripheral arterial disease patients |
Primary outcome
Percentage of home-based GPS recordings that are analyzable
Time frame: December 2011
5 secondary outcomes
"Technical quality" of recorded GPS signals
Time frame: December 2011
Easiness of the interpretation of the GPS measurements
Time frame: December 2011
Adherence of the patients to the protocol
Time frame: December 2011
Compare GPS results to the results obtained with different questionnaires (external validity)
Time frame: December 2011
Sensibility of GPS measurements after (or not) a therapeutic treatment (endovascular treatment, surgery)
Time frame: December 2011
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 18 Mar 2013.
- Derived from this study: PubMed 25950694Gernigon M, Le Faucheur A, Fradin D, Noury-Desvaux B, Landron C, Mahe G, Abraham P. Global positioning system use in the community to evaluate improvements in walking after revascularization: a prospective multicenter study with 6-month follow-up in patients with peripheral arterial disease. Medicine (Baltimore). 2015 May;94(18):e838. doi: 10.1097/MD.0000000000000838.
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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 principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery 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 11 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 18 Mar 2013. 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?
Percentage of home-based GPS recordings that are analyzable (time frame: December 2011). 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 NCT01141361, which also lists 1 linked publication.
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 18 Mar 2013.