Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-27 @ 7:13 AM
Study NCT ID:
NCT04050332
Status:
COMPLETED
Last Update Posted:
2019-11-20
First Post:
2019-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can RFID Technology Capture Stair Walking
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-19', 'studyFirstSubmitDate': '2019-08-02', 'studyFirstSubmitQcDate': '2019-08-06', 'lastUpdatePostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stair walking duration', 'timeFrame': 'Calculated after the completion of the 4-minute stair walking episode', 'description': 'Duration, in seconds, of stair walking as tracked by the RFID equipment'}, {'measure': 'Stair walking distance', 'timeFrame': 'Calculated after the completion of the 4-minute stair walking episode', 'description': 'Distance, in number of stairs climbed, as tracked by the RFID equipment'}, {'measure': 'Stair walking speed', 'timeFrame': 'Calculated after the completion of the 4-minute stair walking episode', 'description': 'Speed of stair walking, in stairs per second based on duration and distance, as tracked by the RFID equipment'}], 'secondaryOutcomes': [{'measure': 'Blood Pressure', 'timeFrame': 'Before stair walking and 2-minutes and 5-minutes post stair walking', 'description': 'Systolic and diastolic blood pressure'}, {'measure': "Borg's Rating of Perceived Exertion", 'timeFrame': 'Immediately after stair walking', 'description': "A one-item measure of a participant's perceived physical effort during an activity. Responses range from 6 (no exertion) to 20 (maximal exertion), where higher scores indicate a greater perceived exertion."}, {'measure': 'Mental Energy', 'timeFrame': 'Before and immediately after stair walking', 'description': 'Measured by self-report using the State Energy and Fatigue Scale. There are 3 items, scored using a number line from 0 to 100, that are summed to generate a score, where higher scores indicate greater mental energy.'}, {'measure': 'Mental Fatigue', 'timeFrame': 'Before and immediately after stair walking', 'description': 'Measured by self-report using the State Energy and Fatigue Scale. There are 3 items, scored using a number line from 0 to 100, that are summed to generate a score, where higher scores indicate greater mental fatigue.'}, {'measure': 'Physical Energy', 'timeFrame': 'Before and immediately after stair walking', 'description': 'Measured by self-report using the State Energy and Fatigue Scale. There are 3 items, scored using a number line from 0 to 100, that are summed to generate a score, where higher scores indicate greater physical energy.'}, {'measure': 'Physical Fatigue', 'timeFrame': 'Before and immediately after stair walking', 'description': 'Measured by self-report using the State Energy and Fatigue Scale. There are 3 items, scored using a number line from 0 to 100, that are summed to generate a score, where higher scores indicate greater physical fatigue.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Radio Frequency Identification Device'], 'conditions': ['Physical Activity', 'Blood Pressure']}, 'descriptionModule': {'briefSummary': 'There are two main aims for this study:\n\n1. conduct a proof-of-concept study illustrating how radio-frequency identification technology can be used to document the timestamps and duration of stair walking (ascending and descending stairs), and detect if an individual is stationary in the stairwell.\n2. assess the association of a 4-min bout of self-paced stair walking with changes in blood pressure, mood, and perceived exertion.', 'detailedDescription': 'Objective, passive methods for measuring physical activity participation can minimize error associated with self-report bias and cognitive processing. This study will test the utility of radio frequency identification (RFID) for the measurement of stair walking within buildings. RFID readers will be placed at stairwell entrances on each floor. Participants will wear a RFID tag. As the participant walks past the different readers going up and down the stairs, the reader will log the date and time. The frequency and duration of time in the stairwell can be calculated, as can an estimated speed.\n\nThere are known effects for blood pressure (hypotensive) and moodafter exercise. However, few studies have assessed this effect for short bouts (\\<10 minutes) of exercise. Participants will have their pre- and post-stair walking blood pressure measured to determine the hypotensive and mood enhancing effects of four minutes of stair walking at a comfortable pace. Participants also will rate the exertion level of four minutes of stair walking at a self-selected pace.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* in desired age range\n\nExclusion Criteria:\n\n* Unable to or uncomfortable climbing stairs\n* Not cleared for exercise using the Physical Activity Readiness Questionnaire (PAR-Q+)'}, 'identificationModule': {'nctId': 'NCT04050332', 'briefTitle': 'Can RFID Technology Capture Stair Walking', 'organization': {'class': 'OTHER', 'fullName': 'University of Georgia'}, 'officialTitle': 'Can RFID Technology Capture Stair Walking: A Pilot Study', 'orgStudyIdInfo': {'id': 'PROJECT00000674'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stair Walking', 'description': 'Participants in this arm will engage in four minutes of stair walking while being tracked by radio frequency identification equipment.', 'interventionNames': ['Behavioral: Stair Walking']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants in this arm will stand in the stairwell for four minutes while being tracked by radio frequency identification equipment.'}], 'interventions': [{'name': 'Stair Walking', 'type': 'BEHAVIORAL', 'description': 'Walking up and down stairs for four minutes at a comfortable pace', 'armGroupLabels': ['Stair Walking']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30602', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': 'Ramsey Center', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}], 'overallOfficials': [{'name': 'Jennifer L Gay, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Georgia'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Upon publication of the primary and secondary outcomes', 'ipdSharing': 'YES', 'description': 'De-identified, data may be shared for primary and secondary outcomes.', 'accessCriteria': 'Data access requests will be reviewed by the study team. Requestors will be required to sign a Data Access Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Georgia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jennifer Gay', 'investigatorAffiliation': 'University of Georgia'}}}}