PAOD (Peripheral Arterial Obstructive Disease)VAPAVNCT00675402
Micro- and Macrovascular Adaptations in Patients With Peripheral Arterial Disease During Supervised Exercise Therapy
An observational study of PAOD (Peripheral Arterial Obstructive Disease), run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Given that previous studies demonstrated the feasibility of the required MRI techniques, we propose to study the macro- and microvascular adaptations in PAOD patients undergoing supervised exercise therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PAOD (Peripheral Arterial Obstructive Disease)
- What is being tested?
- supervised treadmill exercise program
- How many people
- 117 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2009to Jun 2012
- Phase
- Observational
- 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
Study population: Patients referred to the vascular surgeon with complaints of claudication for their first time, will be asked to participate with the study, with respect toward the in- and exclusion criteria.
Who may be able to join
- Intermittent claudication according to a positive Rose-Edingburgh questionnaire
- Rest ankle-brachial pressure index (ABPI) < 0,90 or 10% decline in ABPI after exercise
- Arterial stenosis/occlusion of femoro-popliteal territory according to duplex/MRA measurements
- Able to ondergo exercise therapy
Who cannot join
- Chronic or acute critical ischemia
- Treated by or planned for vascular surgery or percutaneous transluminal angioplasty
- Recent onset <2 months
- Unable to perform treadmill exercise
- Diabetes mellitus
- Contra-indications for (Gadolinium-enhanced) MRI or thigh cuff inflation
Trial locations and contacts
1 site in 1 country.
Bas Versluis contact
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Hospital
Maastricht, Limburg, 6202AZ
Bas Versluis, Bas.versluis@rad.unimaas.nl
About this study
Official title: Micro- and Macrovascular Adaptations in Patients With Peripheral Arterial Disease During Supervised Exercise Therapy: a MRI Study
Given that previous studies demonstrated the feasibility of the required MRI techniques, we propose to study the macro- and microvascular adaptations in PAOD patients undergoing supervised exercise therapy. It is expected to provide valuable insights into the contribution of each vascular mechanism to the rehabilitation and to identify which vascular mechanism fails or is insufficient for a successful rehabilitation. Improvement of future treatment requires the identification of relevant adaptive mechanisms. With this we will provide early noninvasive MRI readout tools to diagnose and monitor the potential rehabilitation during any form of therapy for PAOD that affects the peripheral vasculature.
- Being tested
- supervised treadmill exercise program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supervised treadmill exercise programOther
Supervised treadmill therapy consists of a walking exercise on a treadmill under supervision of a physiotherapist, 2-3 times a week. This program is combined with individual walking every other day and the total duration of the program is 6 months. Guided by the painfree walking distance, every month the angle and/or speed of the treadmill will increase. A standardized protocol for this type of therapy is already in use by many physiotherapists in Limburg (Willigendael, 2005).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients referred to the vascularsurgeon with complaints of claudication for their first time, will be asked to participate with the study, with respect toward the in- and exclusion criteria. Receives: Other: supervised treadmill exercise program |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2008 (estimated)
- Study startJan 2009
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PAOD (Peripheral Arterial Obstructive Disease)Studies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- WH Backes, PhD, Principal investigator, Maastricht University Hospital, dep. of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675402
- Sponsor's protocol ID
- MEC 08-2-032
- Acronym
- VAPAV
- Status last verified
- Mar 2011
- First submitted
- 6 May 2008
- Last updated
- 22 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micro- and Macrovascular Adaptations in Patients With Peripheral Arterial Disease During Supervised Exercise Therapy: a MRI Study
- ClinicalTrials.gov ID
- NCT00675402
- Acronym / sponsor ID
- VAPAV / MEC 08-2-032
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 9 May 2008 (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.
Given that previous studies demonstrated the feasibility of the required MRI techniques, we propose to study the macro- and microvascular adaptations in PAOD patients undergoing supervised exercise therapy. It is expected to provide valuable insights into the contribution of each vascular mechanism to the rehabilitation and to identify which vascular mechanism fails or is insufficient for a successful rehabilitation. Improvement of future treatment requires the identification of relevant adaptive mechanisms. With this we will provide early noninvasive MRI readout tools to diagnose and monitor the potential rehabilitation during any form of therapy for PAOD that affects the peripheral vasculature.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: supervised treadmill exercise programPatients referred to the vascularsurgeon with complaints of claudication for their first time, will be asked to participate with the study, with respect toward the in- and exclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to the vascular surgeon with complaints of claudication for their first time, will be asked to participate with the study, with respect toward the in- and exclusion criteria.
Key inclusion criteria (4 listed)
- Intermittent claudication according to a positive Rose-Edingburgh questionnaire
- Rest ankle-brachial pressure index (ABPI) < 0,90 or 10% decline in ABPI after exercise
- Arterial stenosis/occlusion of femoro-popliteal territory according to duplex/MRA measurements
- Able to ondergo exercise therapy
Key exclusion criteria (6 listed)
- Chronic or acute critical ischemia
- Treated by or planned for vascular surgery or percutaneous transluminal angioplasty
- Recent onset <2 months
- Unable to perform treadmill exercise
- Diabetes mellitus
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 treadmill exercise programSupervised treadmill therapy consists of a walking exercise on a treadmill under supervision of a physiotherapist, 2-3 times a week. This program is combined with individual walking every other day and the total duration of the program is 6 months. Guided by the painfree walking distance, every month the angle and/or speed of the treadmill will increase. A standardized protocol for this type of therapy is already in use by many physiotherapists in Limburg (Willigendael, 2005). | Other | 1 |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2011.
Related trials for PAOD (Peripheral Arterial Obstructive Disease)
Active, not recruiting
Resoloy Initial Safety Evaluation
CLTI Defined as Rutherford Category 4 or 5, PAOD (Peripheral Arterial Obstructive Disease)
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.
Bas Versluis contact
WH Backes, PhD principal investigator
Maastricht University Hospital, dep. of Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PAOD (Peripheral Arterial Obstructive Disease), run by Maastricht University Medical Center at 1 site in Netherlands.
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 6 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 22 Mar 2011. 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 Netherlands. 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 Bas Versluis (Bas.versluis@rad.unimaas.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 22 Mar 2011; AzTrials last refreshed its copy on 7 Nov 2026.