Exercise Training Versus Best Medical Treatment Only in Peripheral Artery Disease
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| First Received Date ICMJE | June 22, 2009 | ||||||||
| Last Updated Date | December 30, 2011 | ||||||||
| Start Date ICMJE | November 2007 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Quality of Life [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00926081 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 | Exercise Training Versus Best Medical Treatment Only in Peripheral Artery Disease | ||||||||
| Official Title ICMJE | Exercise Training Versus Best Medical Treatment Only in Peripheral Artery Disease | ||||||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Peripheral Artery Disease | ||||||||
| Intervention ICMJE | Behavioral: Supervised exercise training
A standardized supervised exercise training program
Other Name: Standardized supervised exercise training |
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| Study Arm (s) |
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| Publications * | Schlager O, Hammer A, Giurgea A, Schuhfried O, Fialka-Moser V, Gschwandtner M, Koppensteiner R, Steiner S. Impact of exercise training on inflammation and platelet activation in patients with intermittent claudication. Swiss Med Wkly. 2012 Aug 14;142:w13623. doi: 10.4414/smw.2012.13623. | ||||||||
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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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 120 | ||||||||
| Estimated Completion Date | December 2014 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Austria | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00926081 | ||||||||
| Other Study ID Numbers ICMJE | EK056/2007 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Oliver Schlager, Medical University of Vienna | ||||||||
| Study Sponsor ICMJE | Medical University of Vienna | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Medical University of Vienna | ||||||||
| Verification Date | December 2011 | ||||||||
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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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