Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-01-06 @ 9:03 PM
Study NCT ID:
NCT05077995
Status:
COMPLETED
Last Update Posted:
2022-05-24
First Post:
2021-10-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validity and Reliability of the Polar M200 Activity Monitor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-23', 'studyFirstSubmitDate': '2021-10-01', 'studyFirstSubmitQcDate': '2021-10-01', 'lastUpdatePostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sedentary time', 'timeFrame': '7 days', 'description': 'Sedentary time'}], 'secondaryOutcomes': [{'measure': 'Steps', 'timeFrame': '7 days', 'description': 'Number of steps'}, {'measure': 'Sleeping time', 'timeFrame': '7 days', 'description': 'Sleeping time'}, {'measure': 'Standing time', 'timeFrame': '7 days', 'description': 'Standing time'}, {'measure': 'Walking time', 'timeFrame': '7 days', 'description': 'Walking and running time'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Persons', 'Fitness Trackers']}, 'descriptionModule': {'briefSummary': 'The aim of this study will be to investigate the validity of a consumer available activity tracker (Polar M200) in free-living conditions to measure sedentary time.', 'detailedDescription': 'The aim of the present study is to evaluate the validity from a commercially available wearable Polar device. Consumer-based activity trackers are generally cheaper, designed for long-term wear and are less intrusive. Potentially, consumer-based activity trackers can be used for research purposes, but high-quality validation studies are needed. The aims of this study will be to assess validity of sedentary outcome measures of a Polar device during free-living conditions in comparison with the ActivPAL3TM activity monitor (AP; PAL Technologies Ltd, Glasgow, UK), which is considered the gold standard to measure sedentary time in free-living conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults\n\nExclusion Criteria:\n\n* /'}, 'identificationModule': {'nctId': 'NCT05077995', 'acronym': 'VAPO', 'briefTitle': 'Validity and Reliability of the Polar M200 Activity Monitor', 'organization': {'class': 'OTHER', 'fullName': 'Hasselt University'}, 'officialTitle': 'Validity and Reliability of the Polar M200 Activity Monitor to Measure Sedentary and Active Time', 'orgStudyIdInfo': {'id': 'VAPO-UH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy adult group', 'description': 'Sixty healthy adults, aged 18-65 years, will be included following written informed consent.', 'interventionNames': ['Device: Polar M200']}], 'interventions': [{'name': 'Polar M200', 'type': 'DEVICE', 'description': 'Participants will have to wear the activity monitors (AP and Polar M200) for at least 7 days. Minutes spent in each activity type will be summed to a total day score. Participants will be instructed to do their regular daily life activities without limitation, but to note their main activity categories in an activity diary, with a main focus on cycling and participation in structured exercise.', 'armGroupLabels': ['Healthy adult group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3500', 'city': 'Hasselt', 'state': 'Limburg', 'country': 'Belgium', 'facility': 'Hasselt University', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}], 'overallOfficials': [{'name': "Bert Op 't Eijnde, Prof. dr.", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hasselt University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasselt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. dr.', 'investigatorFullName': "Bert Op't Eijnde", 'investigatorAffiliation': 'Hasselt University'}}}}