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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Maastricht University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00675402
First received: May 6, 2008
Last updated: March 21, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
PAOD (Peripheral Arterial Obstructive Disease)
Other: supervised treadmill exercise program

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Micro- and Macrovascular Adaptations in Patients With Peripheral Arterial Disease During Supervised Exercise Therapy: a MRI Study

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Estimated Enrollment: 117
Study Start Date: January 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675402

Contacts
Contact: Bas Versluis Bas.versluis@rad.unimaas.nl

Locations
Netherlands
Maastricht University Hospital Recruiting
Maastricht, Limburg, Netherlands, 6202AZ
Contact: Bas Versluis       Bas.versluis@rad.unimaas.nl   
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: WH Backes, PhD Maastricht University Hospital, dep. of Radiology
  More Information

No publications provided

Responsible Party: Bas Versluis, Maastricht University Hospital, dep. of Radiology
ClinicalTrials.gov Identifier: NCT00675402     History of Changes
Other Study ID Numbers: MEC 08-2-032
Study First Received: May 6, 2008
Last Updated: March 21, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis

ClinicalTrials.gov processed this record on August 21, 2014