Feasibility of Home-based Measurement of Walking Capacity Using Global Positioning System in Peripheral Artery Disease (POST-GPS)
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Peripheral Artery Disease |
Procedure: GPS recording(s) of walking capacity in PAD patients |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Feasibility of Home-based Measurement of Walking Capacity Using Global Positioning System in Patients With Peripheral Arterial Disease |
- Percentage of home-based GPS recordings that are analyzable [ Time Frame: December 2011 ] [ Designated as safety issue: No ]
- "Technical quality" of recorded GPS signals [ Time Frame: December 2011 ] [ Designated as safety issue: No ]
- Easiness of the interpretation of the GPS measurements [ Time Frame: December 2011 ] [ Designated as safety issue: No ]
- Adherence of the patients to the protocol [ Time Frame: December 2011 ] [ Designated as safety issue: No ]
- Compare GPS results to the results obtained with different questionnaires (external validity) [ Time Frame: December 2011 ] [ Designated as safety issue: No ]The questionnaires used assess the physical activity level, the quality of life and the walking impairment of the studied PAD patients.
- Sensibility of GPS measurements after (or not) a therapeutic treatment (endovascular treatment, surgery) [ Time Frame: December 2011 ] [ Designated as safety issue: No ]
| Enrollment: | 251 |
| Study Start Date: | July 2009 |
| Study Completion Date: | February 2013 |
| Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Peripheral arterial disease patients
Patients with a peripheral arterial disease, defined by an ankle to brachial index below 0.90
|
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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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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with peripheral arterial disease, defined by an ankle to brachial index below 0.90, or patients with vascular history and having vascular claudication
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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)
Contacts and Locations| France | |
| University Hospital | |
| Angers, France, 49933 | |
| Principal Investigator: | Pierre Abraham, MD, PhD | University Hospital, Angers |
More Information
No publications provided
| Responsible Party: | University Hospital, Angers |
| ClinicalTrials.gov Identifier: | NCT01141361 History of Changes |
| Other Study ID Numbers: | POST-GPS |
| Study First Received: | June 8, 2010 |
| Last Updated: | March 15, 2013 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Angers:
|
Claudication Artery Ambulatory technique GPS |
Additional relevant MeSH terms:
|
Peripheral Arterial Disease Peripheral Vascular Diseases Atherosclerosis Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013