Micro- and Macrovasculair Adaptations in Patients With Peripheral Arterial Disease During Supervised Exercise Therapy - Full Text View

Sponsored by:	Maastricht University Medical Center
Information provided by:	Maastricht University Medical Center
ClinicalTrials.gov Identifier:	NCT00675402

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

MedlinePlus related topics: Exercise and Physical Fitness Rehabilitation

Drug Information available for: Amphetamine Methamphetamine

U.S. FDA Resources

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

Further study details as provided by Maastricht University Medical Center:

Biospecimen Retention: None Retained

Biospecimen Description:

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 fysiotherapist, 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 fysiotherapists in Limburg (Willigendael, 2005).

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 fysiotherapist, 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 fysiotherapists 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 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.

Criteria

Inclusion Criteria:

Intermittent claudication according to a psoitive Rose-Edingburgh questionnaire
Rest ankel-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

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

Contacts

Contact: Bas Versluis

Bas.versluis@rad.unimaas.nl

Locations

Netherlands, Limburg
Maastricht University Hospital
Maastricht, Limburg, Netherlands, 6202AZ

Sponsors and Collaborators

Maastricht University Medical Center

Investigators

Principal Investigator:

WH Backes, PhD

Maastricht University Hospital, dep. of Radiology

More Information

Responsible Party:	Maastricht University Hospital, dep. of Radiology ( Bas Versluis )
Study ID Numbers:	MEC 08-2-032
Study First Received:	May 6, 2008
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00675402
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study placed in the following topic categories:

Arterial Occlusive Diseases
Methamphetamine
Peripheral Vascular Diseases
Vascular Diseases
Amphetamine

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009