Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT04613856
Status:
COMPLETED
Last Update Posted:
2020-11-03
First Post:
2020-10-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Water Bolus Volumes During Continuous Exercise in Heat
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003681', 'term': 'Dehydration'}, {'id': 'D000084462', 'term': 'Hyperthermia'}], 'ancestors': [{'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D018882', 'term': 'Heat Stress Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized, counterbalanced, crossover study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-02', 'studyFirstSubmitDate': '2020-10-30', 'studyFirstSubmitQcDate': '2020-11-02', 'lastUpdatePostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent body mass loss', 'timeFrame': '2 hours', 'description': 'Percent body mass loss after water intake'}, {'measure': 'Core temperature', 'timeFrame': '2 hours', 'description': 'Core temperature after water intake'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dehydration (Physiology)', 'Hyperthermia']}, 'descriptionModule': {'briefSummary': 'Hydration is important to all individuals including occupational workers who complete physical activity in the heat. Current best practice guidelines suggest drinking a cup of water every 15-20 minutes during activity in a hot environment, but research shows this may not be ideal for best maintaining hydration. The goal of this study is to determine if larger, more frequent water boluses better maintain hydration than smaller, less frequent water boluses during moderate intensity physical activity in the heat.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* 18-39 y old\n* Self-reported to be healthy\n\nExclusion Criteria:\n\n* Female\n* Not within defined age range\n* History of any cardiovascular, neurologic, or metabolic disease\n* Current tobacco use or regular use within the last 2 years.\n* Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, beta blockers, diuretics, psychotropics, etc.)\n* Inability to follow the rules of the protocols or understand the consent form'}, 'identificationModule': {'nctId': 'NCT04613856', 'briefTitle': 'Water Bolus Volumes During Continuous Exercise in Heat', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': 'Water Bolus Volumes During Continuous Exercise in Heat', 'orgStudyIdInfo': {'id': 'STUDY00003387'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Current Best Practice - 237 mL water bolus', 'interventionNames': ['Other: Hydration protocol - 237 mL water bolus']}, {'type': 'EXPERIMENTAL', 'label': 'New Intervention - 500 mL water bolus', 'interventionNames': ['Other: Hydration protocol - 500 mL water bolus']}], 'interventions': [{'name': 'Hydration protocol - 237 mL water bolus', 'type': 'OTHER', 'description': 'Subjects consume 237 mL of water every 20 minutes during 2 hours of high intensity work in the heat.', 'armGroupLabels': ['Current Best Practice - 237 mL water bolus']}, {'name': 'Hydration protocol - 500 mL water bolus', 'type': 'OTHER', 'description': 'Subjects consume 500 mL of water every 40 minutes during 2 hours of high intensity work in the heat.', 'armGroupLabels': ['New Intervention - 500 mL water bolus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14214', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Center for Research and Exercise in Special Environments', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD data can be provided upon written request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Riana Pryor', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}