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Exercise Training Versus Best Medical Treatment Only in Peripheral Artery Disease

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ClinicalTrials.gov Identifier: NCT00926081
Recruitment Status : Unknown
Verified December 2011 by Oliver Schlager, Medical University of Vienna.
Recruitment status was:  Recruiting
First Posted : June 23, 2009
Last Update Posted : January 4, 2012
Sponsor:
Information provided by (Responsible Party):
Oliver Schlager, Medical University of Vienna

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.

Condition or disease Intervention/treatment
Peripheral Artery Disease Behavioral: 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise Training Versus Best Medical Treatment Only in Peripheral Artery Disease
Study Start Date : November 2007
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Quality of Life [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Endothelial progenitor cells [ Time Frame: 1 year ]
  2. Inflammatory parameters [ Time Frame: 1 year ]
  3. Ankle brachial index [ Time Frame: 1 year ]
  4. Pain-free walking distance [ Time Frame: 1 year ]
  5. Peripheral transcutaneous oxygen pressure [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926081


Contacts
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

Locations
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         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Sabine Steiner-Boeker, MD Department of Angiology, Medical University Vienna

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
First Posted: June 23, 2009    Key Record Dates
Last Update Posted: January 4, 2012
Last Verified: December 2011

Keywords provided by Oliver Schlager, 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