Peripheral Artery DiseaseNCT00926081
Exercise Training Versus Best Medical Treatment Only in Peripheral Artery Disease
A study testing Supervised exercise training in people with Peripheral Artery Disease, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Supervised exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2007to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Peripheral artery disease with intermittent claudication (Rutherford 2-3)
- Exercise tolerance
- Ankle brachial index < 0,9
- Ability to life independently at home
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Department of Angiology, Vienna Medical University
Vienna, State of Vienna, A-1090
Oliver Schlager, MD, +431 40400 ext. 4670, oliver.schlager@meduniwien.ac.at
Sabine Steiner-Boeker, MD, +431 40400 ext. 4670, sabine.steiner-boeker@meduniwien.ac.at
About this study
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.
Read the 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.
- Conditions
- Peripheral Artery Disease
- Being tested
- Supervised exercise training
- Keywords
- Peripheral Artery Disease, Quality of Life, Outcome, Endothelial Progenitor Cells, Microcirculation
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised exercise trainingBehavioural
Also called Standardized supervised exercise training
A standardized supervised exercise training program
| Study group | Role | What they receive |
|---|---|---|
| Best medical treatment | No intervention | Patients with peripheral artery disease receiving best medical treatment only |
| Supervised exercise training | Active comparator | Patients with peripheral artery disease receiving best medical treatment plus supervised exercise training Receives: Behavioral: Supervised exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Measured: 1 year
Secondary outcomes (5)
Endothelial progenitor cells
Measured: 1 year
Inflammatory parameters
Measured: 1 year
Ankle brachial index
Measured: 1 year
Pain-free walking distance
Measured: 1 year
Peripheral transcutaneous oxygen pressure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startNov 2007
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oliver Schlager, Medical University of Vienna
- Investigators
- Sabine Steiner-Boeker, MD, Principal investigator, Department of Angiology, Medical University Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926081
- Sponsor's protocol ID
- EK056/2007
- Status last verified
- Dec 2011
- First submitted
- 22 Jun 2009
- Last updated
- 4 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22893497
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training Versus Best Medical Treatment Only in Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT00926081
- Acronym / sponsor ID
- EK056/2007
- Conditions
- Peripheral Artery Disease
- Keywords
- Peripheral Artery Disease, Quality of Life, Outcome, Endothelial Progenitor Cells, Microcirculation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 23 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best medical treatment | No intervention | –Patients with peripheral artery disease receiving best medical treatment only |
| Supervised exercise training | Active comparator | Behavioral: Supervised exercise trainingPatients with peripheral artery disease receiving best medical treatment plus supervised exercise training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Peripheral artery disease with intermittent claudication (Rutherford 2-3)
- Exercise tolerance
- Ankle brachial index < 0,9
- Ability to life independently at home
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised exercise trainingAlso: Standardized supervised exercise trainingA standardized supervised exercise training program | Behavioural | Supervised exercise training |
Primary outcome
Quality of Life
Time frame: 1 year
5 secondary outcomes
Endothelial progenitor cells
Time frame: 1 year
Inflammatory parameters
Time frame: 1 year
Ankle brachial index
Time frame: 1 year
Pain-free walking distance
Time frame: 1 year
Peripheral transcutaneous oxygen pressure
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2012.
- Derived from this study: PubMed 22893497Schlager 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine Steiner-Boeker, MD principal investigator
Department of Angiology, Medical University Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised exercise training in people with Peripheral Artery Disease, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oliver Schlager, MD (+431 40400 ext. 4670, oliver.schlager@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00926081, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2012.