Exercise Training Versus Best Medical Treatment Only in Peripheral Artery Disease

Not Applicable

• Conditions: Peripheral Artery Disease
• Interventions: Behavioral: Supervised exercise training

• Registration Number: NCT00926081
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-11
• Study First Submitted: 2009-06-22
• Study First Submitted QC: 2009-06-22
• Study First Posted: 2009-06-23
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-30
• Last Update Posted: 2012-01-04
• Primary Completion: 2013-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supervised exercise training	Supervised exercise training	Patients with peripheral artery disease receiving best medical treatment plus supervised exercise training

Primary Outcome Measures

Name	Time	Method
Quality of Life	1 year

Secondary Outcome Measures

Name	Time	Method
Endothelial progenitor cells	1 year
Inflammatory parameters	1 year
Ankle brachial index	1 year
Pain-free walking distance	1 year
Peripheral transcutaneous oxygen pressure	1 year

Trial Locations

Locations (1)

Department of Angiology, Vienna Medical University; 🇦🇹 Vienna, Austria