Exercise Training Versus Best Medical Treatment Only in Peripheral Artery Disease
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 22, 2009
CompletedFirst Posted
Study publicly available on registry
June 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJanuary 4, 2012
December 1, 2011
6.1 years
June 22, 2009
December 30, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of Life
1 year
Secondary Outcomes (5)
Endothelial progenitor cells
1 year
Inflammatory parameters
1 year
Ankle brachial index
1 year
Pain-free walking distance
1 year
Peripheral transcutaneous oxygen pressure
1 year
Study Arms (2)
Best medical treatment
NO INTERVENTIONPatients with peripheral artery disease receiving best medical treatment only
Supervised exercise training
ACTIVE COMPARATORPatients with peripheral artery disease receiving best medical treatment plus supervised exercise training
Interventions
A standardized supervised exercise training program
Eligibility Criteria
You may qualify if:
- Peripheral artery disease with intermittent claudication (Rutherford 2-3)
- Exercise tolerance
- Ankle brachial index \< 0,9
- Ability to life independently at home
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Angiology, Vienna Medical University
Vienna, Vienna, A-1090, Austria
Related Publications (1)
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.
PMID: 22893497DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sabine Steiner-Boeker, MD
Department of Angiology, Medical University Vienna
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
June 22, 2009
First Posted
June 23, 2009
Study Start
November 1, 2007
Primary Completion
December 1, 2013
Study Completion
December 1, 2014
Last Updated
January 4, 2012
Record last verified: 2011-12