Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-01-08 @ 7:24 AM
Study NCT ID:
NCT03270202
Status:
TERMINATED
Last Update Posted:
2018-11-30
First Post:
2017-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wearable Devices to Promote Physical Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 175}}, 'statusModule': {'whyStopped': 'discontinuation of financial support', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-28', 'studyFirstSubmitDate': '2017-08-30', 'studyFirstSubmitQcDate': '2017-08-30', 'lastUpdatePostDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak oxygen uptake (VO2peak)', 'timeFrame': '16 weeks', 'description': 'Measured by ergospirometry during a maximal treadmill protocol to exhaustion'}], 'secondaryOutcomes': [{'measure': 'Peak oxygen uptake (VO2peak)', 'timeFrame': '1 year', 'description': 'Measured by ergospirometry during a maximal treadmill protocol to exhaustion'}, {'measure': 'Cardiovascular risk profile (ESC Score)', 'timeFrame': '16 weeks', 'description': 'Measured by blood samples and clinical data'}, {'measure': 'Cardiovascular risk profile (ESC Score)', 'timeFrame': '1 year', 'description': 'Measured by blood samples and clinical data'}, {'measure': 'Structural and functional cardiac changes', 'timeFrame': '16 weeks', 'description': 'Measured by echocardiography and CT coronary angiography'}, {'measure': 'Structural and functional cardiac changes', 'timeFrame': '1 year', 'description': 'Measured by echocardiography and CT coronary angiography'}, {'measure': 'Quality of life', 'timeFrame': '16 weeks', 'description': 'Measured by questionnaire SF-36'}, {'measure': 'Quality of life', 'timeFrame': '1 year', 'description': 'Measured by questionnaire SF-36'}, {'measure': 'Adherence to prescribed physical activity', 'timeFrame': '16 weeks', 'description': 'Measured by Mio Slice'}, {'measure': 'Adherence to prescribed physical activity', 'timeFrame': '1 year', 'description': 'Measured by Mio Slice'}, {'measure': 'Feedback from users', 'timeFrame': '16 weeks', 'description': 'Measured by interviews and feedback systems'}, {'measure': 'Feedback from users', 'timeFrame': '1 year', 'description': 'Measured by interviews and feedback systems'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'Cardiorespiratory fitness', 'Risk factors', 'Monitoring, physiologic', 'Monitoring, ambulatory', 'Prognosis', 'Norway'], 'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': "This study evaluates the effect of a new wearable device, that measures physical activity level based on heart rates, on relevant health outcomes including cardiorespiratory fitness. Half of participants will be instructed in using the Mio Slice wristband, while the other half will be requested to follow today's recommendations for physical activity.", 'detailedDescription': 'Two critical challenges precluding the full potential of physical activity in preventive healthcare are: 1) The majority of people are not sufficiently active, and 2) there is a lack of large, long-term intervention studies documenting the effect of personalized activity and improved health in the population. Using HUNT data an algorithm called Personal Activity Intelligence (PAI) has been developed. PAI was integrated in a smartphone application and user friendly wristband (Mio Slice), that measures heart rate continuously and estimates an individual threshold for total physical activity (defined as 100 weekly PAI) that is associated with reduced risk of cardiovascular disease and mortality. The primary aim of the study is to reveal whether using the wristband will increase cardiorespiratory fitness, determined by maximal oxygen uptake, after 4 months among low-fit participants. The secondary aims includes the effect on reversing cardiovascular risk factors, cardiac structure and function, adherence to physical activity and identification of barriers after 16 weeks and 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '23 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participated in HUNT 3 and HUNT 4 Fitness Study\n* VO2peak in HUNT4 in the lowest sex- and age-specific tertile.\n\nExclusion Criteria:\n\n* Illness or disabilities that preclude completion of the study or make exercise contraindicated\n* uncontrolled hypertension, arrhythmias or angina\n* heart failure\n* primary pulmonary hypertension\n* diagnosed dementia\n* chronic communicable infectious diseases\n* participation in conflicting interventions'}, 'identificationModule': {'nctId': 'NCT03270202', 'acronym': 'HUNT4-PAI', 'briefTitle': 'Wearable Devices to Promote Physical Activity', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'The HUNT 4 PAI Study: A Randomized Controlled Intervention Study Using Wearable Devices to Promote Physical Activity', 'orgStudyIdInfo': {'id': '2016/2300'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PAI group', 'description': 'Participants randomized to the PAI-group will receive a wearable device (Mio Slice PAI wristband) that measure heart rate continuously and via an algorithm calculates a physical activity score called PAI. The weekly goal of 100 PAI can be reached by a combination of different intensities and durations and the participants will get continuous information about their current score and amount of activity needed to reach the goal. 100 PAI is expected to approximate current guidelines of 150 minutes of moderate intensity or 75 minutes of vigorous intensity for the average participant or somewhat less if the intensity of the chosen activity is high. Proper instruction in use of the device and App will be given both oral and written after baseline testing and randomization.', 'interventionNames': ['Behavioral: PAI group', 'Behavioral: Usual care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': 'Usual care: Participants in the control group will be informed about, and encouraged to be active according to current recommendations for physical activity from the health authorities.', 'interventionNames': ['Behavioral: Usual care']}], 'interventions': [{'name': 'PAI group', 'type': 'BEHAVIORAL', 'description': '* physical activity defined as 100 weekly PAI during 1 year\n* smartphone application and a user-friendly activity wristband (Mio PAI Slice)', 'armGroupLabels': ['PAI group']}, {'name': 'Usual care', 'type': 'BEHAVIORAL', 'description': 'Participants will be informed about, and encouraged to be active according to current recommendations for physical activity from the health authorities.', 'armGroupLabels': ['PAI group', 'Usual care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trondheim', 'country': 'Norway', 'facility': 'Department of Circulation and Medical Imaging', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Øystein Risa, phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian University of Science and Technology'}, {'name': 'Bjarne Martens Nes, phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Data will be available within 6 months after study completion with no time-frame restriction.', 'ipdSharing': 'YES', 'description': 'After the study ends all data from baseline and follow-up testing will be transferred to HUNT databank and made available for other researchers.', 'accessCriteria': 'Data will be available for national and international institutions after contract with HUNT Research Center and includes a fee.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}