Exercise Training Versus Best Medical Treatment Only in Peripheral Artery Disease
Primary Purpose
Peripheral Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Supervised exercise training
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Artery Disease focused on measuring Peripheral Artery Disease, Quality of Life, Outcome, Endothelial Progenitor Cells, Microcirculation
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)
Sites / Locations
- Department of Angiology, Vienna Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Best medical treatment
Supervised exercise training
Arm Description
Patients with peripheral artery disease receiving best medical treatment only
Patients with peripheral artery disease receiving best medical treatment plus supervised exercise training
Outcomes
Primary Outcome Measures
Quality of Life
Secondary Outcome Measures
Endothelial progenitor cells
Inflammatory parameters
Ankle brachial index
Pain-free walking distance
Peripheral transcutaneous oxygen pressure
Full Information
NCT ID
NCT00926081
First Posted
June 22, 2009
Last Updated
December 30, 2011
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT00926081
Brief Title
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
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease
Keywords
Peripheral Artery Disease, Quality of Life, Outcome, Endothelial Progenitor Cells, Microcirculation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Best medical treatment
Arm Type
No Intervention
Arm Description
Patients with peripheral artery disease receiving best medical treatment only
Arm Title
Supervised exercise training
Arm Type
Active Comparator
Arm Description
Patients with peripheral artery disease receiving best medical treatment plus supervised exercise training
Intervention Type
Behavioral
Intervention Name(s)
Supervised exercise training
Other Intervention Name(s)
Standardized supervised exercise training
Intervention Description
A standardized supervised exercise training program
Primary Outcome Measure Information:
Title
Quality of Life
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Endothelial progenitor cells
Time Frame
1 year
Title
Inflammatory parameters
Time Frame
1 year
Title
Ankle brachial index
Time Frame
1 year
Title
Pain-free walking distance
Time Frame
1 year
Title
Peripheral transcutaneous oxygen pressure
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oliver Schlager, MD
Phone
+431 40400
Ext
4670
Email
oliver.schlager@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Sabine Steiner-Boeker, MD
Phone
+431 40400
Ext
4670
Email
sabine.steiner-boeker@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Steiner-Boeker, MD
Organizational Affiliation
Department of Angiology, Medical University Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Angiology, Vienna Medical University
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Schlager, MD
Phone
+431 40400
Ext
4670
Email
oliver.schlager@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Sabine Steiner-Boeker, MD
Phone
+431 40400
Ext
4670
Email
sabine.steiner-boeker@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Sabine Steiner-Boeker, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
22893497
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.
Results Reference
derived
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Exercise Training Versus Best Medical Treatment Only in Peripheral Artery Disease
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