Skip to content

Exercise Training Versus Best Medical Treatment Only in Peripheral Artery Disease

Exercise Training Versus Best Medical Treatment Only in Peripheral Artery Disease

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00926081
Enrollment
120
Registered
2009-06-23
Start date
2007-11-30
Completion date
2014-12-31
Last updated
2012-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Artery Disease

Keywords

Peripheral Artery Disease, Quality of Life, Outcome, Endothelial Progenitor Cells, Microcirculation

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.

Interventions

A standardized supervised exercise training program

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Quality of Life1 year

Secondary

MeasureTime frame
Endothelial progenitor cells1 year
Inflammatory parameters1 year
Ankle brachial index1 year
Pain-free walking distance1 year
Peripheral transcutaneous oxygen pressure1 year

Countries

Austria

Contacts

Primary ContactOliver Schlager, MD
oliver.schlager@meduniwien.ac.at+431 40400
Backup ContactSabine Steiner-Boeker, MD
sabine.steiner-boeker@meduniwien.ac.at+431 40400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026