Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-04 @ 4:48 PM
Study NCT ID:
NCT02660450
Status:
UNKNOWN
Last Update Posted:
2016-01-21
First Post:
2016-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Aerobic Prescription Methods
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D055656', 'term': 'Prescriptions'}, {'id': 'D016526', 'term': 'Workload'}, {'id': 'D006339', 'term': 'Heart Rate'}], 'ancestors': [{'id': 'D010593', 'term': 'Pharmaceutical Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D010561', 'term': 'Personnel Staffing and Scheduling'}, {'id': 'D010559', 'term': 'Personnel Management'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D055986', 'term': 'Vital Signs'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006439', 'term': 'Hemodynamics'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-17', 'studyFirstSubmitDate': '2016-01-04', 'studyFirstSubmitQcDate': '2016-01-17', 'lastUpdatePostDateStruct': {'date': '2016-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response of Heart Rate and perceived Effort through prescriptions for oxygen uptake', 'timeFrame': 'Acute Change in 5 minutes of moderate aerobic exercise'}, {'measure': 'Response of Heart Rate through prescriptions for self selected workload based in perceived effort', 'timeFrame': 'Acute Change in 5 minutes of moderate aerobic exercise'}, {'measure': 'Response of velocity and Perceived Effort through Prescription of Heart Rate', 'timeFrame': 'Acute Change in 5 minutes of moderate aerobic exercise'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Current literature report 3 ways to prescribe and control aerobic training. Such models require comparison to determine if they really provide the same impact training in a prescription. The aim of this study is to compare the results of different methods of prescription of aerobic training, ie VO2 workload, heart rate (HR), and load self adjusted by perceived effort (PSE) as well as psychological responses activation, and feel depending on the stimuli offered.', 'detailedDescription': '36 subjects will undergo two sessions. On the first visit, a maximum aerobic exercise test will be carried on treadmill to determine the maximum oxygen intake and maximum heart rate. Second, the subjects are placed (in a blinded fashion) in 3 situations of moderate effort (60 to 65%) for a total of 5 min and 3 min interval between conditions. In situation 1) will be used to speed regarding the particular metabolic demand from the maximum oxygen intake; In the second situation the reserve of heart rate will be used as reference for prescription aiming to achieve 60-65%; On the last visit will be shown to subjects a perceived effort characterized as moderate and asked to adjust their speed according to the application effort. The final will be recorded each time the FC and the speed and perception of effort that the subject was.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 at 45 years\n* Risk stratification low\n* Physically active by American College of Sports Medicine criteria\n\nExclusion Criteria:\n\n* Use of ergogenic resources\n* Use of sympatholytic drugs\n* Use of stimulants'}, 'identificationModule': {'nctId': 'NCT02660450', 'briefTitle': 'Relationship Between Aerobic Prescription Methods', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal do Rio de Janeiro'}, 'officialTitle': 'Relationship Between Methods of Aerobic Prescription: Heart Rate vs. VO2 Load vs. Self Selected', 'orgStudyIdInfo': {'id': 'UNIG 02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prescription for Workload', 'description': 'Prescription from 65% VO2max for 5 min of exercise', 'interventionNames': ['Other: Prescription for Heart Rate', 'Other: Prescription Self Selected']}, {'type': 'EXPERIMENTAL', 'label': 'Prescription for Heart Rate', 'description': 'Prescription from 60 - 65% Maximum Heart Rate for 5 min of exercise', 'interventionNames': ['Other: Prescription for Workload', 'Other: Prescription Self Selected']}, {'type': 'EXPERIMENTAL', 'label': 'Prescription Self Selected', 'description': 'Prescription Self Selected from Perceived exertion at 3 - 4 (moderate) for 5 min of exercise', 'interventionNames': ['Other: Prescription for Workload', 'Other: Prescription for Heart Rate']}], 'interventions': [{'name': 'Prescription for Workload', 'type': 'OTHER', 'otherNames': ['VO2Max'], 'description': 'Prescription from 65% VO2max for 5 min of exercise', 'armGroupLabels': ['Prescription Self Selected', 'Prescription for Heart Rate']}, {'name': 'Prescription for Heart Rate', 'type': 'OTHER', 'otherNames': ['Heart Rate'], 'description': 'Prescription from 60 - 65% Maximum Heart Rate for 5 min of exercise', 'armGroupLabels': ['Prescription Self Selected', 'Prescription for Workload']}, {'name': 'Prescription Self Selected', 'type': 'OTHER', 'otherNames': ['Self Selected'], 'description': 'Prescription Self Selected from Perceived exertion at 3 - 4 (moderate) for 5 min of exercise', 'armGroupLabels': ['Prescription for Heart Rate', 'Prescription for Workload']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sérgio Machado, PhD', 'role': 'CONTACT', 'email': 'secm80@gmail.com', 'phone': '55 21 991567006'}, {'name': 'Alberto Sá Filho, Dr.', 'role': 'CONTACT', 'email': 'albsouzar9@yahoo.com.br', 'phone': '55 21 998284879'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal do Rio de Janeiro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctorade in Mental Health', 'investigatorFullName': 'Alberto Souza de Sá Filho', 'investigatorAffiliation': 'Universidade Federal do Rio de Janeiro'}}}}