Feasibility of Home-based Measurement of Walking Capacity Using Global Positioning System in Peripheral Artery Disease (POST-GPS)
15. marts 2013 opdateret af: University Hospital, Angers
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).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
251
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Angers, Frankrig, 49933
- University Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients with peripheral arterial disease, defined by an ankle to brachial index below 0.90, or patients with vascular history and having vascular claudication
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Peripheral arterial disease patients
Patients with a peripheral arterial disease, defined by an ankle to brachial index below 0.90
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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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Percentage of home-based GPS recordings that are analyzable
Tidsramme: December 2011
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December 2011
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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"Technical quality" of recorded GPS signals
Tidsramme: December 2011
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December 2011
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Easiness of the interpretation of the GPS measurements
Tidsramme: December 2011
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December 2011
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Adherence of the patients to the protocol
Tidsramme: December 2011
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December 2011
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Compare GPS results to the results obtained with different questionnaires (external validity)
Tidsramme: December 2011
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The questionnaires used assess the physical activity level, the quality of life and the walking impairment of the studied PAD patients.
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December 2011
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Sensibility of GPS measurements after (or not) a therapeutic treatment (endovascular treatment, surgery)
Tidsramme: December 2011
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December 2011
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Pierre Abraham, MD, PhD, University Hospital, Angers
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2009
Primær færdiggørelse (Faktiske)
1. februar 2013
Studieafslutning (Faktiske)
1. februar 2013
Datoer for studieregistrering
Først indsendt
8. juni 2010
Først indsendt, der opfyldte QC-kriterier
9. juni 2010
Først opslået (Skøn)
10. juni 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
18. marts 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. marts 2013
Sidst verificeret
1. marts 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- POST-GPS
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .