Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT06163456
Status:
COMPLETED
Last Update Posted:
2023-12-08
First Post:
2023-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Cardiorespiratory Fitness and Body Composition on Resting and Post-exercise Indices of Vascular Health in Young Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-30', 'studyFirstSubmitDate': '2023-11-30', 'studyFirstSubmitQcDate': '2023-11-30', 'lastUpdatePostDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'endothelial function', 'timeFrame': 'Baseline and 60 min post-exercise', 'description': 'flow-mediated dilation'}, {'measure': 'arterial stiffness', 'timeFrame': 'Baseline and 60 min post-exercise', 'description': 'augmentation index'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endothelial Dysfunction', 'Arterial Stiffness']}, 'descriptionModule': {'briefSummary': 'This research is being done to determine whether acute exercise causes differences in numbers of novel blood factors associated with vascular health in college-aged adults across different physical activity habits. As only \\~50% of cardiovascular (CV) events can be explained by traditional CV risk factors such as high blood pressure and high cholesterol, it is anticipated that this research will provide a more comprehensive look into novel risk factors that may better explain CV risk and that may be modifiable through regular physical activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '29 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-29 years of age; healthy male and female; Physically inactive, defined as participation in less than 20 min of continuous endurance exercise on fewer than 2 days/week; Recreationally active, defined as participation in 30 min/day of moderate-intensity cardiovascular activity on greater than 4 days/week; Highly active- defined as performing 30-60 min of moderate- to vigorous-intensity endurance exercise greater than 5 days/week.\n\nExclusion Criteria:\n\n* currently pregnant, previously diagnosed coronary heart disease or congenital heart disease, serum total cholesterol \\>200 mg/dl, low-density lipoprotein cholesterol \\>130 mg/dl, high-density lipoprotein cholesterol \\< 35 mg/dl, fasting glucose \\>100 mg/dl, systolic blood pressure \\> 130 mmHg, diastolic blood pressure \\>90 mmHg, and BMI \\>30 kg/m2.'}, 'identificationModule': {'nctId': 'NCT06163456', 'briefTitle': 'Influence of Cardiorespiratory Fitness and Body Composition on Resting and Post-exercise Indices of Vascular Health in Young Adults', 'organization': {'class': 'OTHER', 'fullName': 'Towson University'}, 'officialTitle': 'Influence of Cardiorespiratory Fitness and Body Composition on Resting and Post-exercise Indices of Vascular Health in Young Adults', 'orgStudyIdInfo': {'id': '1810041426'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low fitness', 'interventionNames': ['Other: Acute submaximal exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'moderate fitness', 'interventionNames': ['Other: Acute submaximal exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'high fitness', 'interventionNames': ['Other: Acute submaximal exercise']}], 'interventions': [{'name': 'Acute submaximal exercise', 'type': 'OTHER', 'description': '30 min of treadmill running at 70% of the participants maximal oxygen consumption', 'armGroupLabels': ['high fitness', 'low fitness', 'moderate fitness']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21252-0001', 'city': 'Towson', 'state': 'Maryland', 'country': 'United States', 'facility': 'Towson University', 'geoPoint': {'lat': 39.4015, 'lon': -76.60191}}], 'overallOfficials': [{'name': 'Rian Q Landers-Ramos, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Towson University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Towson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Rian Q. Landers-Ramos', 'investigatorAffiliation': 'Towson University'}}}}