Exercise Training Versus Best Medical Treatment Only in Peripheral Artery Disease

Medical University of Vienna

Status: Unknown

Conditions: Peripheral Artery Disease

Treatments: Behavioral: Supervised exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT00926081

EK056/2007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Best medical treatment

No Intervention group

Description:

Patients with peripheral artery disease receiving best medical treatment only

Supervised exercise training

Active Comparator group

Description:

Patients with peripheral artery disease receiving best medical treatment plus supervised exercise training

Treatment:

Behavioral: Supervised exercise training