Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-31 @ 12:25 PM
Study NCT ID:
NCT03198806
Status:
COMPLETED
Last Update Posted:
2020-07-28
First Post:
2017-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Water Intake Associated With Aerobic Exercise in Coronary
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016683', 'term': 'Supine Position'}, {'id': 'D004326', 'term': 'Drinking'}], 'ancestors': [{'id': 'D011187', 'term': 'Posture'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D004435', 'term': 'Eating'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D004068', 'term': 'Digestive System Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-26', 'studyFirstSubmitDate': '2017-06-19', 'studyFirstSubmitQcDate': '2017-06-21', 'lastUpdatePostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart rate variability', 'timeFrame': 'up to six months', 'description': 'Indices of heart rate variability'}], 'secondaryOutcomes': [{'measure': 'Subjective Effort Perception', 'timeFrame': 'up to six months', 'description': 'Borg Scale'}, {'measure': 'Subjective Pain Perception', 'timeFrame': 'up to six months', 'description': 'Borg CR-10 Scale'}, {'measure': 'Cardiovascular parameter', 'timeFrame': 'up to six months', 'description': 'Heart Rate'}, {'measure': 'Cardiovascular parameter', 'timeFrame': 'up to six months', 'description': 'Blood Pressure'}, {'measure': 'Cardiorespiratory parameter', 'timeFrame': 'up to six months', 'description': 'Respiratory frequency'}, {'measure': 'Cardiorespiratory parameter', 'timeFrame': 'up to six months', 'description': 'Partial Oxygen Saturation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autonomic Nervous System', 'Fluid Therapy', 'Heart Rate', 'Exercise'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The need to restore water losses resulting from physical activity has become established and diffused into international consensus for healthy individuals or high-performance athletes. However, the influence of fluid replacement when administered during and after exercise on cardiorespiratory parameters, cardiac autonomic modulation, and subjective perceptions of effort and pain of individuals with autonomic alterations known as the coronary arteries remain poorly understood. In this sense, this study intends to investigate the influence of hydration on cardiac autonomic modulation, cardiorespiratory parameters, subjective perception of exertion and pain of coronary arteries submitted to aerobic exercise in the model of a cardiovascular rehabilitation session. A total of 31 individuals will be recruited in this study and will perform four standardized cardiovascular rehabilitation sessions. Only in the second and the fourth session will the volunteers be instructed to ingest a quantity of water predetermined by the evaluator, based on the loss of body mass measured in the first and the third sessions. The outcomes (autonomic modulation, cardiorespiratory variables and perceptions) will be evaluated before, during and after exercise. The results of this study will enable professionals working with this population to implement awareness strategies on the importance of fluid intake in cardiovascular rehabilitation programs.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men with coronary heart disease ischemia, over 45 years\n* At least three months of cardiovascular rehabilitation\n\nExclusion Criteria:\n\n* smokers, alcoholics\n* Uncontrolled metabolic disease (eg, uncontrolled diabetes and thyroid diseases)\n* Abnormal hemodynamic responses during exercise such as disproportionate increase / fall of heart rate and / or blood pressure to low / high levels of load\n* myocardial ischemia and / or severe ventricular arrhythmias during the exercise test'}, 'identificationModule': {'nctId': 'NCT03198806', 'briefTitle': 'Water Intake Associated With Aerobic Exercise in Coronary', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Estadual Paulista Júlio de Mesquita Filho'}, 'officialTitle': 'Influence of Hydration on Autonomic Behavior and Cardiorespiratory Parameters of Coronaropathy Submitted to Aerobic Exercise', 'orgStudyIdInfo': {'id': '54864716800005402'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group in supine position', 'description': 'Intervention:\n\n\\- Only treadmill aerobic exercise with 60 min recovery in supine position', 'interventionNames': ['Other: Treadmill aerobic exercise in supine position']}, {'type': 'EXPERIMENTAL', 'label': 'Hydration group in supine position', 'description': 'Interventions:\n\n* Treadmill aerobic exercise with 60 min recovery in supine position\n* Water intake', 'interventionNames': ['Other: Treadmill aerobic exercise and water intake in supine position']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group in orthostatic position', 'description': 'Intervention:\n\n\\- Only treadmill aerobic exercise with 10 min recovery in orthostatic position', 'interventionNames': ['Other: Treadmill aerobic exercise in orthostatic position']}, {'type': 'EXPERIMENTAL', 'label': 'Hydration group in orthostatic position', 'description': 'Interventions:\n\n* Treadmill aerobic exercise with 10 min recovery in orthostatic position\n* Water intake', 'interventionNames': ['Other: Treadmill aerobic exercise and water intake in orthostatic position']}], 'interventions': [{'name': 'Treadmill aerobic exercise in supine position', 'type': 'OTHER', 'description': 'The volunteers will be submitted to a cardiovascular rehabilitation session with 40 minutes of treadmill aerobic exercise followed by 60 minutes of recovery at the supine position.', 'armGroupLabels': ['Control group in supine position']}, {'name': 'Treadmill aerobic exercise and water intake in supine position', 'type': 'OTHER', 'description': 'The volunteers will be submitted to a cardiovascular rehabilitation session with 40 minutes of treadmill aerobic exercise and water intake followed by 60 minutes of recovery at the supine position.', 'armGroupLabels': ['Hydration group in supine position']}, {'name': 'Treadmill aerobic exercise in orthostatic position', 'type': 'OTHER', 'description': 'The volunteers will be submitted to a cardiovascular rehabilitation session with 40 minutes of treadmill aerobic exercise followed by 10 minutes of recovery at the orthostatic position.', 'armGroupLabels': ['Control group in orthostatic position']}, {'name': 'Treadmill aerobic exercise and water intake in orthostatic position', 'type': 'OTHER', 'description': 'The volunteers will be submitted to a cardiovascular rehabilitation session with 40 minutes of treadmill aerobic exercise and water intake followed by 10 minutes of recovery at the orthostatic position.', 'armGroupLabels': ['Hydration group in orthostatic position']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19060-900', 'city': 'Presidente Prudente', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Luiz Carlos Marques Vanderlei', 'geoPoint': {'lat': -22.12556, 'lon': -51.38889}}], 'overallOfficials': [{'name': 'Luiz Carlos Marques Vanderlei, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidade Estadual Paulista - UNESP - Campus de Presidente Prudente'}]}, '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'}}}}