Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
Study NCT ID:
NCT06068504
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-12-04
First Post:
2023-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Shear Stress in the Arteries of the Lower Limbs During Exercise in Patients With Peripheral Arterial Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005080', 'term': 'Exercise Test'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D006361', 'term': 'Heating'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D004780', 'term': 'Environment, Controlled'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2023-09-22', 'studyFirstSubmitQcDate': '2023-09-28', 'lastUpdatePostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Femoral artery diameter [mm]', 'timeFrame': 'Before the intervention and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and 30 minutes into the intervention', 'description': 'Measurements will be obtained through duplex ultrasound in accordance with global recommendations.'}, {'measure': 'Femoral artery shear rate [sec.-1]', 'timeFrame': 'Before the intervention and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and 30 minutes into the intervention', 'description': 'Measurements will be obtained through duplex ultrasound in accordance with global recommendations.'}, {'measure': 'Femoral artery Blood flow [mL/min]', 'timeFrame': 'Before the intervention and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and 30 minutes into the intervention', 'description': 'Measurements will be obtained through duplex ultrasound in accordance with global recommendations.'}], 'secondaryOutcomes': [{'measure': 'Brachial systolic and diastolic blood pressure [mmHg]', 'timeFrame': 'Before the intervention and at 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, and 29 minutes into the intervention', 'description': 'Systolic and diastolic blood pressures will be assessment in the arms with an automatic blood pressure monitor (HEM-742, Omron Healthcare, Japan)'}, {'measure': 'Heart rate [bpm]', 'timeFrame': 'Before and up to 30 minutes into the intervention', 'description': 'Heart rate assessment with a heart rate monitor (Polar H10, Polar®, Finland)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exercise', 'arm-cranking', 'vascular function'], 'conditions': ['Peripheral Arterial Disease']}, 'descriptionModule': {'briefSummary': 'The aim of the study will be to evaluate shear stress and blood flow parameters in lower limb arteries during arm cycle ergometer exercise in participants with peripheral artery disease. Twenty patients participants with peripheral artery disease and claudication symptoms will be recruited. Participants will perform 3 experimental sessions in random order. Iarm-cranking (15 sets of two minutes exercise), warm water foot immersion, and control. During the interventions, blood pressure and heart rate will be assessed every 6 minutes. Measurements of arterial diameter, blood flow, anterograde and retrograde shear stress of the femoral artery will be evaluated using a two-dimensional ultrasound device with spectral Doppler.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of peripheral artery disease or ankle-brachial index less than 0.90 in one or both limbs\n* do not present peripheral neuropathy;\n* be able to exercise after medical approval\n* aged 50 or over.\n\nExclusion Criteria:\n\n* Medication change during the study\n* Health problems that contraindicates the practice of physical exercise.'}, 'identificationModule': {'nctId': 'NCT06068504', 'briefTitle': 'Shear Stress in the Arteries of the Lower Limbs During Exercise in Patients With Peripheral Arterial Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Nove de Julho'}, 'officialTitle': 'Shear Stress in the Arteries of the Lower Limbs During Arm Cranking Exercise in Patients With Peripheral Arterial Disease', 'orgStudyIdInfo': {'id': 'Heating_PAD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm-cranking exercise', 'description': 'Patients will be perform arm-cranking exercise. The exercise will be performed in 15 sets of 2 min of exercise at a moderate intensity (13-15 in Borg scale)', 'interventionNames': ['Other: Arm-cranking exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Heating', 'description': 'Patients will perform 15 sets of 2 min of immersion of their foot in a warm water (42 degrees)', 'interventionNames': ['Other: Heating']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients will remain seated for 60 min'}], 'interventions': [{'name': 'Arm-cranking exercise', 'type': 'OTHER', 'otherNames': ['Arm exercise', 'Exercise'], 'description': 'Arm-cranking exercise', 'armGroupLabels': ['Arm-cranking exercise']}, {'name': 'Heating', 'type': 'OTHER', 'description': 'Immersion of the foot in warm water', 'armGroupLabels': ['Heating']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01504-001', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'University Nove de Julho', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Raphael Dias', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nove de Julho'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'One year after the study completion', 'ipdSharing': 'YES', 'accessCriteria': 'Upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nove de Julho', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Raphael Mendes Ritti Dias', 'investigatorAffiliation': 'University of Nove de Julho'}}}}