Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-31 @ 12:26 PM
Study NCT ID:
NCT01024634
Status:
COMPLETED
Last Update Posted:
2012-12-17
First Post:
2009-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vascular and Neuro-inflammatory Effects of Endurance Exercise Training in African Americans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-14', 'studyFirstSubmitDate': '2009-12-02', 'studyFirstSubmitQcDate': '2009-12-02', 'lastUpdatePostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arterial function', 'timeFrame': 'Pre, following a 4 week control period and after 8 weeks of exercise intervention'}], 'secondaryOutcomes': [{'measure': 'Autonomic function', 'timeFrame': 'Pre, following a 4 week control period and following 8 weeeks of an exercise intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Arterial stiffness', 'Endothelial function', 'Autonomic function', 'Inflammation'], 'conditions': ['Vascular Health', 'Autonomic Function']}, 'referencesModule': {'references': [{'pmid': '39494565', 'type': 'DERIVED', 'citation': 'Maroco JL, Lane AD, Ranadive SM, Yan H, Baynard T, Fernhall B. Aerobic Training Attenuates Differences Between Black and White Adults in Left Ventricular-Vascular Coupling and Wasted Pressure Effort. J Am Heart Assoc. 2024 Nov 5;13(21):e036107. doi: 10.1161/JAHA.124.036107. Epub 2024 Nov 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the effects of endurance exercise training on arterial structure and function, and to examine potential mechanisms producing changes in arterial structure and function in young (18-35 years of age) African Americans when compared to Caucasians.', 'detailedDescription': 'African-Americans are at greater risk than Caucasians for developing hypertension, cardiovascular disease, stroke and renal disease. This is likely related to arterial dysfunction including greater arterial stiffness, and reduced microvascular reactivity of resistance arteries in African-Americans. In addition, African-Americans have higher levels of inflammatory markers, and a greater sympathoexcitatory response to various stressors. This imbalance between sympathetic and reduced parasympathetic activation may directly affect vascular function and potentiate a greater inflammatory response, further altering key structural and functional properties of the vascular wall. The overall aim of this proposal is to test the effects of endurance exercise training on arterial structure and function, and to examine potential mechanisms producing changes in arterial structure and function in young (18-35 years of age) African Americans when compared to Caucasians. We will examine these effects at rest and following a high intensity (maximal cycle ergometry) sympathoexcitation at both pre- and post-intervention time points, since sympathoexcitation may elucidate changes not evident at rest. Because African-Americans have higher levels of arterial stiffness, lower microvascular reactivity, greater responses to sympathoexcitation, greater levels of inflammatory markers and greater vasoconstrictive tone, we hypothesize that African-Americans will show differential responses to exercise training and benefit more compared to a matched group of Caucasians.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects in good health with no cardiovascular, metabolic, or inflammatory disease, who do not use cardiovascular medications or antioxidant vitamin supplementation, including use of anti-inflammatory (including aspirin) or steroidal substances in the past 2 months will be inlcuded\n\nExclusion Criteria:\n\n* Subjects who smoke, are severely obese (body mass index \\> 35 kg/m2), or who have hypertension (blood pressure \\>140/90mmHg), diabetes (fasting glucose \\>110mg/dl), hyperlipidemia, inflammatory disease (rheumatoid arthritis and systemic lupus erythematosus, etc) or diagnosed cardiovascular disease including, coronary heart disease, hypertension and cardiac arrhythmia or renal disease, will be excluded'}, 'identificationModule': {'nctId': 'NCT01024634', 'acronym': 'VINE', 'briefTitle': 'Vascular and Neuro-inflammatory Effects of Endurance Exercise Training in African Americans', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Urbana-Champaign'}, 'officialTitle': 'Vascular and Neuro-inflammatory Effects of Endurance Exercise Training in African Americans', 'orgStudyIdInfo': {'id': 'UIUC 09599'}, 'secondaryIdInfos': [{'id': '1R01HL093249-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01HL093249-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'African American Group', 'description': 'A group of young African American males and females', 'interventionNames': ['Behavioral: Endurance Exercise']}, {'type': 'OTHER', 'label': 'Caucasian Group', 'description': 'a group of young Caucasian men and women', 'interventionNames': ['Behavioral: Endurance Exercise']}], 'interventions': [{'name': 'Endurance Exercise', 'type': 'BEHAVIORAL', 'description': '8 weeks of Endurance exercise training, 3-4 times per week, 45-60 minutes perr session', 'armGroupLabels': ['African American Group', 'Caucasian Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'country': 'United States', 'facility': 'Kinesiology and Community Health Department, University of Illinois at Urbana-Champaign', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}], 'overallOfficials': [{'name': 'Bo Fernhall, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Urbana-Champaign'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Urbana-Champaign', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Bo Fernhall', 'investigatorAffiliation': 'University of Illinois at Urbana-Champaign'}}}}