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

NCT ID: NCT00675402

Last Updated: 2011-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 117 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2012-06-30

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.

Conditions

PAOD (Peripheral Arterial Obstructive Disease)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

supervised treadmill exercise program

Intervention Type: OTHER

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).

Interventions

supervised 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).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Maastricht University Hospital, dep. of Radiology

Principal Investigators

WH Backes, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Hospital, dep. of Radiology

Locations

Maastricht University Hospital

Maastricht, Limburg, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Bas Versluis

Role: CONTACT

Bas.versluis@rad.unimaas.nl

Facility Contacts

Bas Versluis

Role: primary

Bas.versluis@rad.unimaas.nl

Other Identifiers

MEC 08-2-032

Identifier Type: -

Identifier Source: org_study_id