Exercise Training Versus Best Medical Treatment Only in Peripheral Artery Disease

Peripheral Artery Disease Clinical Trial

Official title:

Exercise Training Versus Best Medical Treatment Only in Peripheral Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00926081
• Other study ID #: EK056/2007
• Status: Recruiting
• Phase: N/A
• First received: June 22, 2009
• Last updated: December 30, 2011
• Start date: November 2007
• Est. completion date: December 2014

Study information

• Verified date: December 2011
• Source: Medical University of Vienna
• Contact: Oliver Schlager, MD
• Phone: +431 40400
• Email: oliver.schlager[@]meduniwien.ac.at
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Behavioral:
• Supervised exercise training
A standardized supervised exercise training program

Locations

Country	Name	City	State
Austria	Department of Angiology, Vienna Medical University	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life		1 year	No
Secondary	Endothelial progenitor cells		1 year	No
Secondary	Inflammatory parameters		1 year	No
Secondary	Ankle brachial index		1 year	No
Secondary	Pain-free walking distance		1 year	No
Secondary	Peripheral transcutaneous oxygen pressure		1 year	No