Exercise Training Versus Best Medical Treatment Only in Peripheral Artery Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2011 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Oliver Schlager, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00926081
First received: June 22, 2009
Last updated: December 30, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Peripheral Artery Disease
Behavioral: Supervised exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exercise Training Versus Best Medical Treatment Only in Peripheral Artery Disease

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Endothelial progenitor cells [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Inflammatory parameters [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Ankle brachial index [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Pain-free walking distance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Peripheral transcutaneous oxygen pressure [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: November 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Best medical treatment
Patients with peripheral artery disease receiving best medical treatment only
Active Comparator: Supervised exercise training
Patients with peripheral artery disease receiving best medical treatment plus supervised exercise training
Behavioral: Supervised exercise training
A standardized supervised exercise training program
Other Name: Standardized supervised exercise training

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926081

Contacts
Contact: Oliver Schlager, MD +431 40400 ext 4670 oliver.schlager@meduniwien.ac.at
Contact: Sabine Steiner-Boeker, MD +431 40400 ext 4670 sabine.steiner-boeker@meduniwien.ac.at

Locations
Austria
Department of Angiology, Vienna Medical University Recruiting
Vienna, Austria, A-1090
Contact: Oliver Schlager, MD    +431 40400 ext 4670    oliver.schlager@meduniwien.ac.at   
Contact: Sabine Steiner-Boeker, MD    +431 40400 ext 4670    sabine.steiner-boeker@meduniwien.ac.at   
Principal Investigator: Sabine Steiner-Boeker, MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Sabine Steiner-Boeker, MD Department of Angiology, Medical University Vienna
  More Information

No publications provided by Medical University of Vienna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oliver Schlager, Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00926081     History of Changes
Other Study ID Numbers: EK056/2007
Study First Received: June 22, 2009
Last Updated: December 30, 2011
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
Peripheral Artery Disease
Quality of Life
Outcome
Endothelial Progenitor Cells
Microcirculation

Additional relevant MeSH terms:
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014