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

PAOD (Peripheral Arterial Obstructive Disease) Clinical Trial

— VAPAV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00675402
• Other study ID #: MEC 08-2-032
• Status: Recruiting
• Phase: N/A
• First received: May 6, 2008
• Last updated: March 21, 2011
• Start date: January 2009
• Est. completion date: June 2012

Study information

• Verified date: March 2011
• Source: Maastricht University Medical Center
• Contact: Bas Versluis
• Email: Bas.versluis[@]rad.unimaas.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 117
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• PAOD (Peripheral Arterial Obstructive Disease)
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Other:
• 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).

Locations

Country	Name	City	State
Netherlands	Maastricht University Hospital	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands,