Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-31 @ 10:25 PM
Study NCT ID:
NCT05231434
Status:
COMPLETED
Last Update Posted:
2022-02-09
First Post:
2022-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Hydration and Functional Aerobic Capacity on the Nonlinear Dynamics of Heart Rate in Healthy Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014867', 'term': 'Water'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-04-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-28', 'studyFirstSubmitDate': '2022-01-05', 'studyFirstSubmitQcDate': '2022-01-28', 'lastUpdatePostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Pressure', 'timeFrame': 'up to 3 weeks', 'description': 'Will occur indirectly, using a stethoscope and an aneroid sphygmomanometer in the left arm. The indicated values will be registered in an individual form. To avoid errors in the determination of blood pressures in volunteers, a single evaluator will measure these variables throughout the experimental procedure. Data will be collected at the end of the 10 minutes of initial rest and at minutes 30, 60 and 90 during exercise on the treadmill, as well as will be collected at minutes 1, 5, 10, 20, 30, 40, 50 and 60 of recovery.'}, {'measure': 'Heart Rate', 'timeFrame': 'up to 3 weeks', 'description': 'The heart rate will be captured beat by beat using the Polar RS800CX frequency meter, equipment previously validated to capture this parameter. Data will be collected at the end of the 10 minutes of initial rest and at minutes 30, 60 and 90 during exercise on the treadmill, as well as will be collected at minutes 1, 5, 10, 20, 30, 40, 50 and 60 of recovery.'}, {'measure': 'Autonomic Modulation - SD1 index', 'timeFrame': 'up to 3 weeks', 'description': 'the data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. The SD1 index corresponds to the dispersion of points perpendicular to the line of identity of the ellipse obtained from the Poincaré plot. Expressed in milliseconds.'}, {'measure': 'Autonomic Modulation - SD2 index', 'timeFrame': 'up to 3 weeks', 'description': 'The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. The SD2 index corresponds to the dispersion of points along the line of identity of the ellipse obtained from the Poincaré plot. Expressed in milliseconds.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exercise', 'hydration', 'non-linear dynamic', 'Autonomic nervous system'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to analyze the influence of hydration and functional aerobic capacity in young and healthy individuals on non-linear heart rate dynamics as a technique that favor faster and more efficient recovery cardiac autonomic modulation.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* include healthy and male individuals, age between 18 and 30 years and physically active.\n\nExclusion Criteria:\n\n* individuals who smoke and drink, those who have infections, metabolic and respiratory diseases that may interfere in the results and orthopedic problems.'}, 'identificationModule': {'nctId': 'NCT05231434', 'briefTitle': 'Influence of Hydration and Functional Aerobic Capacity on the Nonlinear Dynamics of Heart Rate in Healthy Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Estadual Paulista Júlio de Mesquita Filho'}, 'officialTitle': 'Influence of Hydration and Functional Capacity on the Recovery of Nonlinear Heart Rate Dynamics in Healthy Individuals: Crossover Clinical Trial', 'orgStudyIdInfo': {'id': '38152620.5.0000.5402'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control protocol', 'description': 'The control protocol will consist of an initial 10 minutes of rest, followed by 90 minutes of aerobic activity and 60 minutes of the final recovery. Hydration will not be allowed throughout the protocol', 'interventionNames': ['Other: aerobic activity']}, {'type': 'EXPERIMENTAL', 'label': 'Hydration protocol', 'description': 'The control protocol will consist of an initial 10 minutes of rest, followed by 90 minutes of aerobic activity and 60 minutes of the final recovery. In this protocol, volunteers will be hydrated with mineral water from the 15th minute of exercise until the end of recovery', 'interventionNames': ['Other: water', 'Other: aerobic activity']}], 'interventions': [{'name': 'water', 'type': 'OTHER', 'description': 'hydration with mineral water in 10 equal portions, administered at regular intervals from the 15th minute of exercise until the end of the recovery period.', 'armGroupLabels': ['Hydration protocol']}, {'name': 'aerobic activity', 'type': 'OTHER', 'description': 'aerobic activity', 'armGroupLabels': ['Control protocol', 'Hydration protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19060-300', 'city': 'Presidente Prudente', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Universidade Estadual Júlio de Mesquita Filho', 'geoPoint': {'lat': -22.12556, 'lon': -51.38889}}], 'overallOfficials': [{'name': 'thamyres rangel R barros', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Estadual Júlio de Mesquita Filho'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Estadual Paulista Júlio de Mesquita Filho', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Luiz Carlos Marques Vanderlei', 'investigatorAffiliation': 'Universidade Estadual Paulista Júlio de Mesquita Filho'}}}}