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

NCT00675402 | Unknown

• 1 other identifier: MEC 08-2-032
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 1

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 Arms (1)

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.

Other: supervised treadmill exercise program

Interventions

supervised treadmill exercise program 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).

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Hospital

Maastricht, Limburg, 6202AZ, Netherlands

RECRUITING

Study Officials

• WH Backes, PhD

  Maastricht University Hospital, dep. of Radiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bas Versluis

CONTACT

Bas.versluis@rad.unimaas.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 6, 2008
• First Posted: May 9, 2008
• Study Start: January 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: March 22, 2011

Record last verified: 2011-03

Locations

NL (1)