Exercise Training Versus Best Medical Treatment Only in Peripheral Artery Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2014-12-31

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.

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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.

Conditions

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Peripheral Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Best medical treatment

Patients with peripheral artery disease receiving best medical treatment only

Group Type NO_INTERVENTION

No interventions assigned to this group

Supervised exercise training

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

Group Type ACTIVE_COMPARATOR

Supervised exercise training

Intervention Type BEHAVIORAL

A standardized supervised exercise training program

Interventions

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Supervised exercise training

A standardized supervised exercise training program

Intervention Type BEHAVIORAL

Other Intervention Names

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Standardized supervised exercise training

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No