Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT00675402
Status:
UNKNOWN
Last Update Posted:
2011-03-22
First Post:
2008-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Micro- and Macrovascular Adaptations in Patients With Peripheral Arterial Disease During Supervised Exercise Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 117}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-03-21', 'studyFirstSubmitDate': '2008-05-06', 'studyFirstSubmitQcDate': '2008-05-08', 'lastUpdatePostDateStruct': {'date': '2011-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['PAOD (Peripheral Arterial Obstructive Disease)']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intermittent claudication according to a positive Rose-Edingburgh questionnaire\n* Rest ankle-brachial pressure index (ABPI) \\< 0,90 or 10% decline in ABPI after exercise\n* Arterial stenosis/occlusion of femoro-popliteal territory according to duplex/MRA measurements\n* Able to ondergo exercise therapy\n\nExclusion Criteria:\n\n* Chronic or acute critical ischemia\n* Treated by or planned for vascular surgery or percutaneous transluminal angioplasty\n* Recent onset \\<2 months\n* Unable to perform treadmill exercise\n* Diabetes mellitus\n* Contra-indications for (Gadolinium-enhanced) MRI or thigh cuff inflation'}, 'identificationModule': {'nctId': 'NCT00675402', 'acronym': 'VAPAV', 'briefTitle': 'Micro- and Macrovascular Adaptations in Patients With Peripheral Arterial Disease During Supervised Exercise Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Micro- and Macrovascular Adaptations in Patients With Peripheral Arterial Disease During Supervised Exercise Therapy: a MRI Study', 'orgStudyIdInfo': {'id': 'MEC 08-2-032'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': '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.', 'interventionNames': ['Other: supervised treadmill exercise program']}], 'interventions': [{'name': 'supervised treadmill exercise program', 'type': 'OTHER', 'description': '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).', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6202AZ', 'city': 'Maastricht', 'state': 'Limburg', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Bas Versluis', 'role': 'CONTACT', 'email': 'Bas.versluis@rad.unimaas.nl'}], 'facility': 'Maastricht University Hospital', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'centralContacts': [{'name': 'Bas Versluis', 'role': 'CONTACT', 'email': 'Bas.versluis@rad.unimaas.nl'}], 'overallOfficials': [{'name': 'WH Backes, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Hospital, dep. of Radiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Bas Versluis', 'oldOrganization': 'Maastricht University Hospital, dep. of Radiology'}}}}