Ignite Creation Date:
2025-12-26 @ 10:33 AM
Ignite Modification Date:
2025-12-31 @ 7:30 PM
Study NCT ID:
NCT03101228
Status:
COMPLETED
Last Update Posted:
2020-04-08
First Post:
2017-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medical and Physiological Benefits of Reduced Sitting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Due to the nature of the intervention, masking of the participants is not possible. Analyzing of the obtained data will be masked.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A parallel-group randomised controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-07', 'studyFirstSubmitDate': '2017-03-24', 'studyFirstSubmitQcDate': '2017-03-30', 'lastUpdatePostDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in whole-body insulin sensitivity', 'timeFrame': 'The change from baseline to 6 months', 'description': 'M-value during the hyperinsulinemic euglycemic clamp'}, {'measure': 'The change in skeletal muscle insulin-stimulated glucose uptake', 'timeFrame': 'The change from baseline to 6 months', 'description': 'Glucose uptake in the femoral muscles will be measured by positron emission tomography (PET) with \\[18F\\]-labelled fluoro-deoxy-glucose (FDG) tracer during hyperinsulinemic euglycemic clamp'}], 'secondaryOutcomes': [{'measure': 'daily sitting hours', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'Accelerometry data will be collected during the whole intervention period by a triaxial hip-mounted accelerometer'}, {'measure': 'daily hours spent physically active', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'Accelerometry data will be collected during the whole intervention period by a triaxial hip-mounted accelerometer'}, {'measure': 'The change in liver adiposity', 'timeFrame': 'The change from baseline to 6 months', 'description': 'Liver fat content will be assessed using magnetic resonance spectroscopy (MRS)'}, {'measure': 'The change in maximal oxygen uptake', 'timeFrame': 'The change from baseline to 6 months', 'description': 'Maximal oxygen uptake (VO2peak) will be determined by cycle ergometry with direct respiratory measurements. Exercise intensity will be started at 50 W and the intensity will be increased by 25 W at every two minutes until the criteria used to establish the VO2peak are met. The criteria used to establish the VO2peak are a plateau in VO2 despite of an increase in intensity and a respiratory quotient greater than 1.1. or volitional fatigue.'}, {'measure': 'The change in body fat percentage', 'timeFrame': 'The change from baseline to 3 months', 'description': 'Air displacement plethysmography (the Bod Pod system, COSMED, Inc., Concord, CA, USA) will be used to measure body composition (fat mass and fat free mass) with thoracic gas volume being predicted.'}, {'measure': 'The change in body fat percentage', 'timeFrame': 'The change from baseline to 6 months', 'description': 'Air displacement plethysmography (the Bod Pod system, COSMED, Inc., Concord, CA, USA) will be used to measure body composition (fat mass and fat free mass) with thoracic gas volume being predicted.'}, {'measure': 'The change in plasma glucose', 'timeFrame': 'The change from baseline to 3 months', 'description': 'Plasma glucose content will be measured from fasting venous blood samples using standard assays'}, {'measure': 'The change in plasma glucose', 'timeFrame': 'The change from baseline to 6 months', 'description': 'Plasma glucose content will be measured from fasting venous blood samples using standard assays'}, {'measure': 'The change in HbA1c', 'timeFrame': 'The change from baseline to 3 months', 'description': 'Glycated hemoglobin will be measured from fasting venous blood samples using standard assays'}, {'measure': 'The change in HbA1c', 'timeFrame': 'The change from baseline to 6 months', 'description': 'Glycated hemoglobin will be measured from fasting venous blood samples using standard assays'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Physical Activity', 'Metabolic Syndrome', 'Insulin Sensitivity', 'Cardiovascular Risk Factor', 'Sedentary Lifestyle', 'Accelerometry'], 'conditions': ['Metabolic Syndrome', 'Physical Activity', 'Insulin Resistance', 'Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '41125692', 'type': 'DERIVED', 'citation': 'Norha J, Sjoros T, Garthwaite T, Laine S, Laitinen K, Houttu N, Vaha-Ypya H, Sievanen H, Loyttyniemi E, Vasankari T, Knuuti J, Kalliokoski KK, Heinonen IHA. Secondary analysis of a randomised controlled trial on reducing sedentary behaviour and its effects on quality of life and wellbeing. Sci Rep. 2025 Oct 22;15(1):36861. doi: 10.1038/s41598-025-20836-7.'}, {'pmid': '40781908', 'type': 'DERIVED', 'citation': 'Garthwaite T, Sjoros T, Laine S, Koivumaki M, Vaha-Ypya H, Norha J, Kallio P, Saarenhovi M, Loyttyniemi E, Sievanen H, Houttu N, Laitinen K, Kalliokoski KK, Vasankari T, Knuuti J, Heinonen I. Successfully Reducing Sitting Time Can Improve Metabolic Flexibility. Scand J Med Sci Sports. 2025 Aug;35(8):e70113. doi: 10.1111/sms.70113.'}, {'pmid': '39414998', 'type': 'DERIVED', 'citation': 'Ylinen VP, Sjoros T, Laine S, Garthwaite T, Norha J, Vaha-Ypya H, Loyttyniemi E, Houttu N, Laitinen K, Kalliokoski KK, Sievanen H, Vasankari T, Knuuti J, Heinonen IH. Sedentary behavior reduction and blood lipids in adults with metabolic syndrome: a 6-month randomized controlled trial. Sci Rep. 2024 Oct 16;14(1):24241. doi: 10.1038/s41598-024-75579-8.'}, {'pmid': '39343453', 'type': 'DERIVED', 'citation': 'Norha J, Sjoros T, Garthwaite T, Laine S, Verho T, Saunavaara V, Laitinen K, Houttu N, Hirvonen J, Vaha-Ypya H, Sievanen H, Loyttyniemi E, Vasankari T, Kalliokoski K, Heinonen I. Effects of reducing sedentary behaviour on back pain, paraspinal muscle insulin sensitivity and muscle fat fraction and their associations: a secondary analysis of a 6-month randomised controlled trial. BMJ Open. 2024 Sep 28;14(9):e084305. doi: 10.1136/bmjopen-2024-084305.'}, {'pmid': '38575674', 'type': 'DERIVED', 'citation': 'Sjoros T, Norha J, Johansson R, Laine S, Garthwaite T, Vaha-Ypya H, Loyttyniemi E, Kalliokoski KK, Sievanen H, Vasankari T, Knuuti J, Heinonen IHA. Tiredness after work associates with less leisure-time physical activity. Sci Rep. 2024 Apr 4;14(1):7965. doi: 10.1038/s41598-024-58775-4.'}, {'pmid': '36251378', 'type': 'DERIVED', 'citation': 'Sjoros T, Laine S, Garthwaite T, Vaha-Ypya H, Loyttyniemi E, Koivumaki M, Houttu N, Laitinen K, Kalliokoski KK, Sievanen H, Vasankari T, Knuuti J, Heinonen IHA. Reducing Sedentary Time and Whole-Body Insulin Sensitivity in Metabolic Syndrome: A 6-Month Randomized Controlled Trial. Med Sci Sports Exerc. 2023 Mar 1;55(3):342-353. doi: 10.1249/MSS.0000000000003054. Epub 2022 Oct 13.'}, {'pmid': '34582633', 'type': 'DERIVED', 'citation': 'Norha J, Hautala AJ, Sjoros T, Laine S, Garthwaite T, Knuuti J, Loyttyniemi E, Vaha-Ypya H, Sievanen H, Vasankari T, Heinonen IHA. Standing time and daily proportion of sedentary time are associated with pain-related disability in a one month accelerometer measurement in adults with overweight or obesity. Scand J Pain. 2021 Sep 27;22(2):317-324. doi: 10.1515/sjpain-2021-0108. Print 2022 Apr 26.'}, {'pmid': '33239818', 'type': 'DERIVED', 'citation': 'Sjoros T, Vaha-Ypya H, Laine S, Garthwaite T, Lahesmaa M, Laurila SM, Latva-Rasku A, Savolainen A, Miikkulainen A, Loyttyniemi E, Sievanen H, Kalliokoski KK, Knuuti J, Vasankari T, Heinonen IHA. Both sedentary time and physical activity are associated with cardiometabolic health in overweight adults in a 1 month accelerometer measurement. Sci Rep. 2020 Nov 25;10(1):20578. doi: 10.1038/s41598-020-77637-3.'}]}, 'descriptionModule': {'briefSummary': 'The most important objective of this randomized controlled trial in subjects with increased cardiovascular and metabolic risk factors is to investigate whether only reduced daily sitting improves human cardiovascular and metabolic health during a six-month intervention. It is hypothesized and expected that only reduced sitting, without formal physical activity or exercise training, affects favorably cardiovascular and metabolic health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physically inactive (less than 120 minutes of moderate intensity exercise per week measured by the activity monitor during run-in)\n* Sitting time ≥ 10 h /day (measured by the activity monitor during run-in)\n* BMI 25-40\n* Blood pressure \\< 160/100 mmHg\n* Fasting plasma glucose \\< 7.0 mmol/l\n* Fulfills the criteria of the metabolic syndrome according to Alberti et al 2009\n\nExclusion Criteria:\n\n* History of a cardiac event\n* Insulin or medically treated diabetes\n* Any chronic disease or condition that could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results\n* Presence of ferromagnetic objects that would make MR imaging contraindicated\n* Abundant use of alcohol\n* Use of narcotics\n* Smoking of tobacco or consuming snuff tobacco\n* Diagnosed depressive or bipolar disorder\n* Previous PET imaging or considerable exposure to radiation'}, 'identificationModule': {'nctId': 'NCT03101228', 'briefTitle': 'Medical and Physiological Benefits of Reduced Sitting', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'Medical and Physiological Benefits and Mechanisms of Reduced Sitting Without Meeting the Current Physical Activity Recommendations', 'orgStudyIdInfo': {'id': 'T91/2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reduced sitting', 'description': 'Objectively measured daily inactive time will be reduced by one hour compared to the baseline.', 'interventionNames': ['Behavioral: Reduced sitting']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Subjects will be guided to maintain their normal sedentary behaviour and physical activity habits.'}], 'interventions': [{'name': 'Reduced sitting', 'type': 'BEHAVIORAL', 'description': 'Subjects are guided to limit their sitting time during the day for 1 hour/day, by adding light activity with the help of an activity monitor. Subjects are not encouraged to increase their moderate to vigorous physical activity levels.', 'armGroupLabels': ['Reduced sitting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20521', 'city': 'Turku', 'country': 'Finland', 'facility': 'Turku PET Centre', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'overallOfficials': [{'name': 'Juhani Knuuti, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Turku PET Centre, Turku University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'IPD of the main outcome measures will be opened if possible.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'UKK Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ilkka Heinonen', 'investigatorAffiliation': 'University of Turku'}}}}