Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-27 @ 8:55 AM
Study NCT ID:
NCT03333850
Status:
COMPLETED
Last Update Posted:
2018-12-07
First Post:
2017-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Technology Assisted Physical Activity Among Hospitalised Patients With Respiratory Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012120', 'term': 'Respiration Disorders'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'There will be sequential inclusion to each cohort. Each sequence includes 18 patients (corresponding to the number of beds at the department). Thus the patients hospitalised during the first period will receive feedback (exposed cohort). In the second period the patients will not receive feedback (non-exposed cohort), and so forth. A total of 108 patients will be included resulting in 6 periods of 18 patients each.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-06', 'studyFirstSubmitDate': '2017-10-30', 'studyFirstSubmitQcDate': '2017-11-04', 'lastUpdatePostDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mortality', 'timeFrame': '7 Days', 'description': 'Mortality at any time during hospitalisation will be recorded.'}], 'primaryOutcomes': [{'measure': 'Time spent out of bed during hospitalisation', 'timeFrame': '7 Days', 'description': 'Time (in minutes) spent out of bed measured in minutes related to the total hospitalisation time. The time spent out of bed will be recorded throughout the hospitalisation for a maximum of 7 days.'}], 'secondaryOutcomes': [{'measure': 'Time spent sitting during hospitalisation', 'timeFrame': '7 Days', 'description': 'Time (in minutes) spent sitting related to the total hospitalisation time. The time sitting will be recorded throughout the hospitalisation for a maximum of 7 days.'}, {'measure': 'Time spent standing during hospitalisation', 'timeFrame': '7 Days', 'description': 'Time (in minutes) spent standing related to the total hospitalisation time. The time standing will be recorded throughout the hospitalisation for a maximum of 7 days.'}, {'measure': 'Time spent walking during hospitalisation', 'timeFrame': '7 Days', 'description': 'Time (in minutes) spent walking related to the total hospitalisation time. The time walking will be recorded throughout the hospitalisation for a maximum of 7 days.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Disease']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate if patients hospitalised for medical disease will increase their time spent out of bed during hospitalisation through simple feedback about physical activities from a mobile device.\n\nPhysical activity is measured by means of a pair of accelerometers embedded in band aids placed on the thigh and on the chest. The measurement is continuous and data is uploaded to a secure internet-server. Summaries of physical activity (bedrest, sitting, standing, walking) is computed and can be displayed on a mobile device (tablet) through a dedicated application.\n\nThe study will be conducted as a controlled cohort study in a large tertiary public hospital in Copenhagen, Denmark. Patients admitted to Department of Respiratory Medicine will be included and will have their physical activity measured during hospitalisation. Half of the cohort will receive visual feedback about the amount of physical activity from a mobile device placed on the bed table.\n\nA total of 108 patients will be included resulting in 6 periods of 18 patients each.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Is admitted to the Department of Respiratory Medicine\n2. Has signed informed consent\n3. Reads and speaks Danish\n\nExclusion Criteria:\n\n1. Any condition that, in the opinion of the investigator, makes the person unfit for participation\n2. Has allergy towards band aid'}, 'identificationModule': {'nctId': 'NCT03333850', 'acronym': 'TAPAS', 'briefTitle': 'Technology Assisted Physical Activity Among Hospitalised Patients With Respiratory Disease', 'organization': {'class': 'OTHER', 'fullName': 'Frederiksberg University Hospital'}, 'officialTitle': 'Technology Assisted Physical Activity Among Hospitalised Patients With Respiratory Disease - a Controlled Cohort Study', 'orgStudyIdInfo': {'id': 'FYS010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Visual feedback of physical activity', 'description': 'Participants in the exposure cohort will receive usual hospital care and continuous measurement of physical activity by sensors collecting physical activity level during hospitalisation AND a monitor placed at their bedside that displays information about their physical activity level, in terms of time spent bedridden, sitting, standing and walking. This information will be visible to the health personnel, the patients and their relatives.', 'interventionNames': ['Device: Visual feedback of physical activity', 'Device: Measurement of physical activity']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No feedback of physical activity', 'description': 'The participants in the non-exposure cohort will receive usual hospital care and continuous measurement of physical activity by sensors collecting physical activity level during hospitalisation. No visual feedback is provided.', 'interventionNames': ['Device: No feedback of physical activity', 'Device: Measurement of physical activity']}], 'interventions': [{'name': 'Visual feedback of physical activity', 'type': 'DEVICE', 'description': 'A monitor (tablet) will display the level of physical activity during hospitalisation. The monitor will be placed at the bedside (table).', 'armGroupLabels': ['Visual feedback of physical activity']}, {'name': 'No feedback of physical activity', 'type': 'DEVICE', 'description': 'There will be no visual feedback of the physical activity (no monitor placed at the bedside (table)).', 'armGroupLabels': ['No feedback of physical activity']}, {'name': 'Measurement of physical activity', 'type': 'DEVICE', 'description': 'A pair of accelerometers placed on the chest and on the thigh will measure the physical activity level during hospitalisation. The measurement is made continuously and stored on a secure web-server.', 'armGroupLabels': ['No feedback of physical activity', 'Visual feedback of physical activity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Bispebjerg Hospital, Department of Physical and Occupational Therapy', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Christian H Dall, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Physio- and Occupational Therapy, Bispebjerg-Frederiksberg Hospital, Denmark'}, {'name': 'Marius Henriksen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Physio- and Occupational Therapy, Bispebjerg-Frederiksberg Hospital, Denmark'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'When data has been anonymised, analysed, and the scientific report(s) published.', 'ipdSharing': 'YES', 'description': 'When data has been anonymised, analysed, and the scientific report(s) published, the data will be made available to other researchers. Availability will be through direct contact to the study director or principal investigator.', 'accessCriteria': 'The are no criteria specified at this time'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marius Henriksen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Marius Henriksen', 'investigatorAffiliation': 'Frederiksberg University Hospital'}}}}