Exercise Training Versus Best Medical Treatment Only in Peripheral Artery Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Exercise Training Versus Best Medical Treatment Only in Peripheral Artery Disease

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Behavioral: Supervised exercise training


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Best medical treatment<br>Patients with peripheral artery disease receiving best medical treatment only | |
| Active Comparator: Supervised exercise training<br>Patients with peripheral artery disease receiving best medical treatment plus supervised exercise training | Behavioral: Supervised exercise training<br>* A standardized supervised exercise training program<br>* Other names: Standardized supervised exercise training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Artery Disease, Quality of Life, Outcome, Endothelial Progenitor Cells, Microcirculation