Feasibility of Home-based Measurement of Walking Capacity Using Global Positioning System in Peripheral Artery Disease (POST-GPS)
| Tracking Information | |||||
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| First Received Date ICMJE | June 8, 2010 | ||||
| Last Updated Date | March 15, 2013 | ||||
| Start Date ICMJE | July 2009 | ||||
| Primary Completion Date | February 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Percentage of home-based GPS recordings that are analyzable [ Time Frame: December 2011 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01141361 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Feasibility of Home-based Measurement of Walking Capacity Using Global Positioning System in Peripheral Artery Disease | ||||
| Official Title ICMJE | Feasibility of Home-based Measurement of Walking Capacity Using Global Positioning System in Patients With Peripheral Arterial Disease | ||||
| Brief 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). 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). |
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| 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). |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| 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 |
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| Condition ICMJE | Peripheral Artery Disease | ||||
| Intervention ICMJE | Procedure: GPS recording(s) of walking capacity in PAD patients
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.
Other Names:
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| Study Group/Cohort (s) | Peripheral arterial disease patients
Patients with a peripheral arterial disease, defined by an ankle to brachial index below 0.90
Intervention: Procedure: GPS recording(s) of walking capacity in PAD patients |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 251 | ||||
| Completion Date | February 2013 | ||||
| Primary Completion Date | February 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Non-Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01141361 | ||||
| Other Study ID Numbers ICMJE | POST-GPS | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | University Hospital, Angers | ||||
| Study Sponsor ICMJE | University Hospital, Angers | ||||
| Collaborators ICMJE | Région des Pays de la Loire | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Angers | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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