Clinical trial NCT00926081: Exercise Training Versus Best Medical Treatment Only in Peripheral Artery Disease
Official title: Exercise Training Versus Best Medical Treatment Only in Peripheral Artery Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Artery Disease
Keywords: Peripheral Artery Disease
Quality of Life
Outcome
Endothelial Progenitor Cells
Microcirculation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-06-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Quality of Life
timeFrame: 1 year
Secondary outcomes:
measure: Endothelial progenitor cells
timeFrame: 1 year
measure: Inflammatory parameters
timeFrame: 1 year
measure: Ankle brachial index
timeFrame: 1 year
measure: Pain-free walking distance
timeFrame: 1 year
measure: Peripheral transcutaneous oxygen pressure
timeFrame: 1 year
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Angiology, Vienna Medical University
Study officials:
affiliation: Department of Angiology, Medical University Vienna
name: Sabine Steiner-Boeker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schlager O, Hammer A, Giurgea A, Schuhfried O, Fialka-Moser V, Gschwandtner M, Koppensteiner R, Steiner S. Impact of exercise training on inflammation and platelet activation in patients with intermittent claudication. Swiss Med Wkly. 2012 Aug 14;142:w13623. doi: 10.4414/smw.2012.13623. eCollection 2012.