- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00926081
Exercise Training Versus Best Medical Treatment Only in Peripheral Artery Disease
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Peripheral arterial disease (PAD) affects 7 - 12% of the population aged over 50 years. Over an age of 60 years up to 20% are suffering from PAD in Western societies. Both, percutaneous transluminal angioplasty (PTA) and surgical repair (bypass graft, thrombectomy) are well established procedures to improve peripheral arterial perfusion. However, long-term results remain disappointing: Low patency-rates are associated with clinical deterioration. Moreover, clinical outcome is often limited by early major cardiovascular adverse events (myocardial infarction, stroke).
Therefore, medical therapy plays a major role in the management of PAD patients: Antihypertensive medication, statins as well as an adequate diabetes therapy are important cornerstones in the therapeutical management of PAD. Prior studies have shown that regular supervised exercise training can improve patients´walking impairment.
We hypothesize that regular supervised exercise training significantly improves Quality of Life and decreases the occurence of future major cardiovascular adverse events. We further aim to investigate the effect of exercise training on peripheral microcirculation and endothelial progenitor cells.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
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Vienna, Østrig, A-1090
- Rekruttering
- Department of Angiology, Vienna Medical University
-
Kontakt:
- Oliver Schlager, MD
- Telefonnummer: 4670 +431 40400
- E-mail: oliver.schlager@meduniwien.ac.at
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Kontakt:
- Sabine Steiner-Boeker, MD
- Telefonnummer: 4670 +431 40400
- E-mail: sabine.steiner-boeker@meduniwien.ac.at
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Ledende efterforsker:
- Sabine Steiner-Boeker, MD
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Peripheral artery disease with intermittent claudication (Rutherford 2-3)
- Exercise tolerance
- Ankle brachial index < 0,9
- Ability to life independently at home
Exclusion Criteria:
- No PAD
- Asymptomatic PAD
- Ischemic rest pain
- Exercise tolerance limited by other factors than claudication (e.g., coronary artery disease, dyspnoea, poorly controlled blood pressure, any kind of restriction of the musculoskeletal system which might have an influence on the efficiency of exercise training)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Best medical treatment
Patients with peripheral artery disease receiving best medical treatment only
|
|
Aktiv komparator: Supervised exercise training
Patients with peripheral artery disease receiving best medical treatment plus supervised exercise training
|
A standardized supervised exercise training program
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Livskvalitet
Tidsramme: 1 år
|
1 år
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Endothelial progenitor cells
Tidsramme: 1 year
|
1 year
|
Inflammatory parameters
Tidsramme: 1 year
|
1 year
|
Ankle brachial index
Tidsramme: 1 year
|
1 year
|
Pain-free walking distance
Tidsramme: 1 year
|
1 year
|
Peripheral transcutaneous oxygen pressure
Tidsramme: 1 year
|
1 year
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Sabine Steiner-Boeker, MD, Department of Angiology, Medical University Vienna
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EK056/2007
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 .
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