Exercise Training Versus Best Medical Treatment Only in Peripheral Artery Disease

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

Study Description

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	Phase
Peripheral Artery Disease	Behavioral: Supervised exercise training	Not Applicable

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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)

Contacts and Locations

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. eCollection 2012.

• 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
• 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