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Micro- and Macrovascular Adaptations in Patients With Peripheral Arterial Disease During Supervised Exercise Therapy

Micro- and Macrovascular Adaptations in Patients With Peripheral Arterial Disease During Supervised Exercise Therapy: a MRI Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00675402
Acronym
VAPAV
Enrollment
117
Registered
2008-05-09
Start date
2009-01-31
Completion date
2012-06-30
Last updated
2011-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PAOD (Peripheral Arterial Obstructive Disease)

Brief 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. 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.

Interventions

OTHERsupervised treadmill exercise program

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).

Sponsors

Maastricht University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Countries

Netherlands

Contacts

Primary ContactBas Versluis
Bas.versluis@rad.unimaas.nl

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026