Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT03649893
Status:
UNKNOWN
Last Update Posted:
2019-10-02
First Post:
2018-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectivness of Active Office Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057185', 'term': 'Sedentary Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised Controlled Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-12-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-01', 'studyFirstSubmitDate': '2018-08-24', 'studyFirstSubmitQcDate': '2018-08-27', 'lastUpdatePostDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weekly physical activity levels', 'timeFrame': '5 days', 'description': 'Weekly physical activity levels will be measured with ActivePal sensors.'}, {'measure': 'Weekly sitting time', 'timeFrame': '5 days', 'description': 'Weekly sitting time will be measured with ActivePal sensors.'}], 'secondaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': '5 days', 'description': 'Heart rate will be measured with Polar Heart Rate Monitor.'}, {'measure': 'Blood Pressure', 'timeFrame': 'Baseline and after 5 days', 'description': 'Blood pressure will be measured with electronic blood pressure monitor.'}, {'measure': 'Global Physical Activity Questionnaire', 'timeFrame': 'Baseline and after 5 days', 'description': 'Global Physical Activity Questionnaire is used to subjectively assess physical activity levels.'}, {'measure': 'Sedentary Behavior Questionnaire', 'timeFrame': 'Baseline and after 5 days', 'description': 'Sedentary Behavior Questionnaire is used to subjectively assess sedentary behavior.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sedentary behavior', 'phyical activity', 'workplace interventions', 'active breaks', 'workplace ergonomics'], 'conditions': ['Sedentary Lifestyle']}, 'descriptionModule': {'briefSummary': 'The Active Office study is focusing on interventions with potential to reduce sedentary behavior and increase physical activity in office workers. The participants will be devided in two groups, the experimental and the control group. The participants in the experimental group will use active office (sit-to-stand desk, bike desk, seddle chair and active breaks) for one week, whereas the control group will remain in the conventional sitting-desk office. All the participants will wear ActivePal for 5 consecutive day and complete the measurements (heart rate, blood pressure). The goal of the study is to evaluate the effects of active office on sedentary behavior and physical activity levels in office workers.', 'detailedDescription': 'Sedentary behavior is racognised as an independent risk factor for the development of non-communicable diseases. It is estimated that office workers spent up to 80 % of their working time sedentary and do not compensate by sitting less in their leisure time. Therefore, interventions with potential to reduce sedentary behavior and increase phyical activity levels are of increasing interest. The aim of this study is to evaluate the effects of active office, including sit-to-stand desk, bike desk, seddle chair, and active breaks, on sedentary behavior, physical activity levels, and cardio-vascular parameters. The study design will be randomised control trial with one experimental and one control group. The participants in the experimental group will use active office for one week whereas the control group will use the conventional office. All the participants will wear ActivePal for 5 consecutive day and complete the measurements (heart rate, blood pressure). The participants will also complete quastionaires about the sedentary behavior and physical activity levels (Sedentary Behavior Questionnaire, Global Physical Activity Questionnaire). Moreover, at the baseline and on the last day of measurements the investigators will measure the work environment factors (light, noise, air flow, temperature). The goal of the study is to evaluate the effects of active office on sedentary behavior and physical activity levels in office workers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* office workers spending at least 70 % of their working time sedentary\n* aged between 18 and 65\n\nExclusion Criteria:\n\n* body mass index \\> 30kg/m2\n* pain presence in any musculokeletal part \\> 3 on 10-level scale\n* presence of any non-communicable chronical diseases\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT03649893', 'acronym': 'ActiveOffice', 'briefTitle': 'Effectivness of Active Office Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University of Primorska'}, 'officialTitle': 'The Effectivness of Multi-modal Intervention for Reducing Sedentary Behavior in Office Workers', 'orgStudyIdInfo': {'id': 'Active Office'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'The control group will use conventional siiting-desk office.'}, {'type': 'EXPERIMENTAL', 'label': 'Active Office Group', 'description': 'The experimental group will use active offfice, including sit-to-stand desk, bike desk, seddle chair and active breask.', 'interventionNames': ['Device: Active Office']}], 'interventions': [{'name': 'Active Office', 'type': 'DEVICE', 'description': 'Active Office intervention includes sit-to-stand desk, bike desk, seddle chair, and active breaks.', 'armGroupLabels': ['Active Office Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6310', 'city': 'Izola', 'country': 'Slovenia', 'contacts': [{'name': 'Nejc Sarabon, Phd', 'role': 'CONTACT', 'email': 'nejc.sarabon@fvz.upr.si', 'phone': '+386 5 662 64 66', 'phoneExt': '00386'}], 'facility': 'InnoRenew', 'geoPoint': {'lat': 45.53661, 'lon': 13.66015}}], 'centralContacts': [{'name': 'Nejc Sarabon, Phd', 'role': 'CONTACT', 'email': 'nejc.sarabon@fvz.upr.si', 'phone': '+386 5 662 64 66', 'phoneExt': '00386'}], 'overallOfficials': [{'name': 'Nejc Sarabon, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Primorska'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Primorska', 'class': 'OTHER'}, 'collaborators': [{'name': 'Innorenew CoE', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. Dr. Sc.', 'investigatorFullName': 'Nejc Sarabon', 'investigatorAffiliation': 'University of Primorska'}}}}