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

• Conditions: PAOD (Peripheral Arterial Obstructive Disease)
• Interventions: Other: supervised treadmill exercise program

• Registration Number: NCT00675402
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-05-06
• Study First Submitted QC: 2008-05-08
• Study First Posted: 2008-05-09
• Study Start: 2009-01
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-21
• Last Update Posted: 2011-03-22
• Primary Completion: 2012-06
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 117

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	supervised treadmill exercise program	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.

Trial Locations

Locations (1)

Maastricht University Hospital; 🇳🇱 Maastricht, Limburg, Netherlands