Exercise Training Versus Best Medical Treatment Only in Peripheral Artery Disease
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Purpose
The aim of the investigators' study is to analyze the value of supervised exercise training combined with medical therapy versus best medical treatment only with respect to quality of life. Furthermore, the investigators aim to evaluate the effect of supervised exercise training on microcirculation, peripheral endothelial progenitor cells as well as on future major cardiovascular adverse events.
| Condition | Intervention |
|---|---|
|
Peripheral Artery Disease |
Behavioral: Supervised exercise training |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Exercise Training Versus Best Medical Treatment Only in Peripheral Artery Disease |
- Quality of Life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Endothelial progenitor cells [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Inflammatory parameters [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Ankle brachial index [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Pain-free walking distance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Peripheral transcutaneous oxygen pressure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Best medical treatment
Patients with peripheral artery disease receiving best medical treatment only
|
|
|
Active Comparator: Supervised exercise training
Patients with peripheral artery disease receiving best medical treatment plus supervised exercise training
|
Behavioral: Supervised exercise training
A standardized supervised exercise training program
Other Name: Standardized supervised exercise training
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| Contact: Oliver Schlager, MD | +431 40400 ext 4670 | oliver.schlager@meduniwien.ac.at |
| Contact: Sabine Steiner-Boeker, MD | +431 40400 ext 4670 | sabine.steiner-boeker@meduniwien.ac.at |
| Austria | |
| Department of Angiology, Vienna Medical University | Recruiting |
| Vienna, Austria, A-1090 | |
| Contact: Oliver Schlager, MD +431 40400 ext 4670 oliver.schlager@meduniwien.ac.at | |
| Contact: Sabine Steiner-Boeker, MD +431 40400 ext 4670 sabine.steiner-boeker@meduniwien.ac.at | |
| Principal Investigator: Sabine Steiner-Boeker, MD | |
| Principal Investigator: | Sabine Steiner-Boeker, MD | Department of Angiology, Medical University Vienna |
More Information
No publications provided by Medical University of Vienna
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Oliver Schlager, Dr., Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT00926081 History of Changes |
| Other Study ID Numbers: | EK056/2007 |
| Study First Received: | June 22, 2009 |
| Last Updated: | December 30, 2011 |
| Health Authority: | Austria: Ethikkommission |
Keywords provided by Medical University of Vienna:
|
Peripheral Artery Disease Quality of Life Outcome Endothelial Progenitor Cells Microcirculation |
Additional relevant MeSH terms:
|
Peripheral Arterial Disease Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases |
Vascular Diseases Cardiovascular Diseases Peripheral Vascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013