Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-02-17 @ 9:00 PM
Study NCT ID:
NCT01989104
Status:
COMPLETED
Last Update Posted:
2022-12-01
First Post:
2013-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cadence and Intensity in Children and Adolescents (CADENCE-KIDS)
Sponsor:
Organization:
Raw JSON
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age', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Adolescents Group 2', 'description': '15-17 years of age', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Young Adults', 'description': '18-20 years of age', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cadence - Steps Per Minute', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Children Group 1', 'description': '6-8 years of age'}, {'id': 'OG001', 'title': 'Children Group 2', 'description': '9-11 years of age'}, {'id': 'OG002', 'title': 'Adolescents Group 1', 'description': '12-14 years of age'}, {'id': 'OG003', 'title': 'Adolescents Group 2', 'description': '15-17 years of age'}, {'id': 'OG004', 'title': 'Young Adults', 'description': '18-20 years of age'}], 'classes': [{'title': 'Moderate Intensity', 'categories': [{'measurements': [{'value': '128.4', 'groupId': 'OG000', 'lowerLimit': '121.7', 'upperLimit': '134.5'}, {'value': '116.5', 'groupId': 'OG001', 'lowerLimit': '109.3', 'upperLimit': '123.9'}, {'value': '106.6', 'groupId': 'OG002', 'lowerLimit': '102.5', 'upperLimit': '111.0'}, {'value': '101.3', 'groupId': 'OG003', 'lowerLimit': '97.5', 'upperLimit': '104.8'}, {'value': '87.3', 'groupId': 'OG004', 'lowerLimit': '79.4', 'upperLimit': '95.7'}]}]}, {'title': 'Vigorous Intensity', 'categories': [{'measurements': [{'value': '157.7', 'groupId': 'OG000', 'lowerLimit': '151.8', 'upperLimit': '164.0'}, {'value': '142.7', 'groupId': 'OG001', 'lowerLimit': '134.6', 'upperLimit': '152.8'}, {'value': '129.3', 'groupId': 'OG002', 'lowerLimit': '124.1', 'upperLimit': '135.6'}, {'value': '126.3', 'groupId': 'OG003', 'lowerLimit': '122.9', 'upperLimit': '129.8'}, {'value': '129.9', 'groupId': 'OG004', 'lowerLimit': '126.3', 'upperLimit': '133.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'Cadence steps per minute represents an overlooked opportunity to describe the intensity of ambulatory activity.', 'unitOfMeasure': 'Cadence - Steps per Minute', 'dispersionType': '99% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Children Group 1', 'description': '6-8 years of age'}, {'id': 'FG001', 'title': 'Children Group 2', 'description': '9-11 years of age'}, {'id': 'FG002', 'title': 'Adolescents Group 1', 'description': '12-14 years of age'}, {'id': 'FG003', 'title': 'Adolescents Group 2', 'description': '15-17 years of age'}, {'id': 'FG004', 'title': 'Young Adults', 'description': '18-20 years of age'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '24'}, {'groupId': 'FG004', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '24'}, {'groupId': 'FG004', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '120', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Children Group 1', 'description': '6-8 years of age'}, {'id': 'BG001', 'title': 'Children Group 2', 'description': '9-11 years of age'}, {'id': 'BG002', 'title': 'Adolescents Group 1', 'description': '12-14 years of age'}, {'id': 'BG003', 'title': 'Adolescents Group 2', 'description': '15-17 years of age'}, {'id': 'BG004', 'title': 'Young Adults', 'description': '18-20 years of age'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '96', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '60', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '60', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '42', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '75', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '120', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-07-13', 'size': 729295, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-05-09T12:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-07', 'studyFirstSubmitDate': '2013-11-14', 'resultsFirstSubmitDate': '2019-05-09', 'studyFirstSubmitQcDate': '2013-11-14', 'lastUpdatePostDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-11-07', 'studyFirstPostDateStruct': {'date': '2013-11-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cadence - Steps Per Minute', 'timeFrame': '1 day', 'description': 'Cadence steps per minute represents an overlooked opportunity to describe the intensity of ambulatory activity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Indirect calorimetry'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '34271922', 'type': 'DERIVED', 'citation': 'Gould ZR, Mora-Gonzalez J, Aguiar EJ, Schuna JM Jr, Barreira TV, Moore CC, Staudenmayer J, Tudor-Locke C. A catalog of validity indices for step counting wearable technologies during treadmill walking: the CADENCE-Kids study. Int J Behav Nutr Phys Act. 2021 Jul 16;18(1):97. doi: 10.1186/s12966-021-01167-y.'}, {'pmid': '29482554', 'type': 'DERIVED', 'citation': 'Tudor-Locke C, Schuna JM Jr, Han H, Aguiar EJ, Larrivee S, Hsia DS, Ducharme SW, Barreira TV, Johnson WD. Cadence (steps/min) and intensity during ambulation in 6-20 year olds: the CADENCE-kids study. Int J Behav Nutr Phys Act. 2018 Feb 26;15(1):20. doi: 10.1186/s12966-018-0651-y.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to measure and link cadence (number of steps taken in a minute) to intensity of physical activity (e.g., low-intensity, moderate-intensity, vigorous-intensity) in children and adolescents (6-20 years-old), and to identify the cadence values corresponding to children's and adolescent's behavior during simulated free-living activities.", 'detailedDescription': 'Procedure - 1 visit - (approximately 3 hours in total)\n\nDay of Testing: Participant must be FASTED - No food for 4 hours before visit. All of the study procedures involving the participant will be completed in a single testing session (one-day - approximately 3 hours) at the Pennington Biomedical Research Center. If preferred, two visits on separate days can be scheduled to complete the protocol.\n\n* Screening questions (approximately 3-5 minutes)\n\n o Participants (or their legal guardian) will be asked to answer several screening questions to determine their eligibility for participating in CADENCE-KIDS.\n* Height and weight measures data collection (approximately 10 minutes)\n\n * Height will be measured.\n * Body weight and body fat percentage will be measured using a specialized scale.\n * Waist circumference will then be measured using a measuring tape.\n* Instrument attachment, treadmill walking, free-living activities (approximately 140 minutes)\n\n * Participants will be fitted with 10 devices (Digi-Walker Pedometer, NL-1000 Pedometer, StepWatch Activity Monitor, SenseWear Armband, GT3X+ accelerometer, GENEActiv Accelerometer, Actical Accelerometer, ActivPal Accelerometer, Polar Heart Rate Monitor, K4b2 Portable Metabolic Unit) to measure/monitor physical activity throughout the testing session.\n * Participants will then complete several low intensity free-living activities while their physical activity and oxygen uptake are concurrently assessed. Specifically, participants will rest in a chair, watch a portion of a child-friendly movie while seated in a chair, and color in a coloring book while seated in a chair. Each activity will last for 5 minutes and a 2 minute rest will occur between each activity.\n * Participants will then complete a series of walking bouts on a treadmill while their physical activity and oxygen uptake are concurrently assessed. The walking bouts start at 0.5 miles per hour and end at 5 miles per hour (0.5 miles per hour increments). Treadmill testing stops when the participant finishes the bout where they naturally select to jog/run, or following the completion of the last bout at 5.0 miles per hour, whichever occurs first. A 2 minute rest will occur between each treadmill bout.\n * Participants will then complete three additional free-living activities where physical activity and oxygen uptake continue to be concurrently measured. Specifically, participants will step up and down on an aerobic step at 88 beats per minute, dribble a basketball, and perform jumping jacks at 126 beats per minute (63 jumping jacks per minute). Each activity will last for 5 minutes and a 2 minute rest will occur between each activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community sample', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 6 to 20 years of age at the time of study enrollment\n* Not limited in the ability to walk\n\nExclusion Criteria:\n\n* Hospitalization for mental illness within the past 5 years.\n* Any condition/medication that may affect heart rate response to exercise testing.\n* Previous history of, or clinical symptoms or signs of, cardiovascular disease, stroke or transient ischemic attacks, chest pain, unusual dyspnea during physical activity/exercise, severe ankle edema, or intermittent claudication.\n* Previous history of musculoskeletal injuries or problems causing severe pain during physical activity or exercise which interferes with daily activities.\n* Participant has a pacemaker or other implanted medical device (including metal joint replacements).\n* Participant is pregnant.\n* Participant is unable to complete all testing (1 or two sessions, as preferred) within a maximal two week period.'}, 'identificationModule': {'nctId': 'NCT01989104', 'briefTitle': 'Cadence and Intensity in Children and Adolescents (CADENCE-KIDS)', 'organization': {'class': 'OTHER', 'fullName': 'Pennington Biomedical Research Center'}, 'officialTitle': 'Cadence and Intensity in Children and Adolescents (CADENCE-KIDS)', 'orgStudyIdInfo': {'id': 'PBRC 13019'}, 'secondaryIdInfos': [{'id': '1R21HD073807-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R21HD073807-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children', 'description': '6-12 years of age'}, {'label': 'Adolescents', 'description': '13-17 years of age'}, {'label': 'Young adults', 'description': '18-20 years of age'}]}, 'contactsLocationsModule': {'locations': [{'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}], 'overallOfficials': [{'name': 'Catrine Tudor-Locke, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Massachusetts, Amherst'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pennington Biomedical Research Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}