Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-02-27 @ 7:31 AM
Study NCT ID:
NCT01962259
Status:
COMPLETED
Last Update Posted:
2018-08-02
First Post:
2013-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Active Commuting To Improve Well-being and Health in Everyday Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 188}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-31', 'studyFirstSubmitDate': '2013-09-25', 'studyFirstSubmitQcDate': '2013-10-11', 'lastUpdatePostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exercise compliance', 'timeFrame': 'Baseline, 3 and 6 month', 'description': 'Adherence to the exercise protocol as measured using heart rate and global positioning system monitors will be assessed and individually adjusted continuously over the course of the exercise intervention'}], 'primaryOutcomes': [{'measure': 'Peripheral insulin sensitivity (glucose clearance ml/min/kg fat-free mass/nM insulin)', 'timeFrame': 'Change from baseline in peripheral insulin sensitivity at 3 months', 'description': 'Measured using the hyper-insulinemic euglycaemic clamp'}, {'measure': 'Peripheral insulin sensitivity (glucose clearance ml/min/kg fat-free mass/nM insulin)', 'timeFrame': 'Change from baseline in peripheral insulin sensitivity at 6 months', 'description': 'Measured using the hyper-insulinemic euglycaemic clamp'}, {'measure': 'Haemostatic balance', 'timeFrame': 'Change from baseline in endogenous thrombin potential at 3 months', 'description': 'Blood coagulation measured by fasting levels of endogenous thrombin potential (nM x min)'}, {'measure': 'Haemostatic balance', 'timeFrame': 'Change from baseline in endogenous thrombin potential at 6 months', 'description': 'Blood coagulation measured by fasting levels of endogenous thrombin potential (nM x min)'}], 'secondaryOutcomes': [{'measure': 'Glycaemic control', 'timeFrame': 'Baseline, 3 and 6 months', 'description': 'Fasting plasma glucose, 1- and 2-hour plasma glucose and glucose area under the curve measured during an oral glucose tolerance test'}, {'measure': 'Central insulin sensitivity', 'timeFrame': 'Baseline, 3 and 6 months', 'description': 'Fasting plasma insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test'}, {'measure': 'Maximal oxygen uptake (ml/O2/kg/min)', 'timeFrame': 'Baseline, 3 and 6 months', 'description': 'Measured using indirect calorimetry and an incremental bicycle protocol'}, {'measure': 'Abdominal fat mass', 'timeFrame': 'Baseline, 3 and 6 months', 'description': 'Visceral intrabdominal and subcutaneous fat mass determined by magnetic resonance imaging'}, {'measure': 'Metabolic syndrome', 'timeFrame': 'Baseline, 3 and 6 months', 'description': 'As measured by high density lipoprotein, triglycerides, waist circumference, blood pressure, mean arterial pressure, fasting glucose and composite metabolic syndrome scores'}, {'measure': 'Haemostatic balance II', 'timeFrame': 'Baseline, 3 and 6 months', 'description': '1: Coagulation: Fibrinogen, Tissue factor(TF), prothrombin fragment 1+2. 2: Fibrinolysis: Tissue type plasminogen activator(tPA:AG), Plasminogen activator inhibitor type 1(PAI-1:AG). 3: Endothelial cell function: von Willebrand factor(vWF), Tissue factor pathway inhibitor (TFPI). 4: Inflammation: C-Reactive protein.'}, {'measure': 'Health related quality of life and other psycho-social outcomes', 'timeFrame': 'Baseline, 3 and 6 months', 'description': 'Measured using questionaries (SF-36), semi-structured interviews and observations'}, {'measure': 'Anthropometry', 'timeFrame': 'Baseline, 3 and 6 months', 'description': 'Measured using dual x-ray absorptiometry, height, weight, waist and hip circumference, sagittal abdominal height'}, {'measure': 'Sleep habits', 'timeFrame': 'Baseline, 3 and 6 months', 'description': 'Sleep duration and quality measured using accelerometers, logs and questionaires (Pittsburgh sleep quality index and Epworth sleepiness scale)'}, {'measure': 'Skeletal muscle biopsy', 'timeFrame': 'Baseline, 3 and 6 months', 'description': 'Biochemical, proteomics, metabolomics, genomics and morphological analyses'}, {'measure': 'Subcutaneous adipose tissue biopsy', 'timeFrame': 'Baseline, 3 and 6 months', 'description': 'Biochemical, proteomics, metabolomics, genomics and morphological analyses'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Overweight and Obesity']}, 'referencesModule': {'references': [{'pmid': '31467422', 'type': 'DERIVED', 'citation': 'Kern T, Blond MB, Hansen TH, Rosenkilde M, Quist JS, Gram AS, Ekstrom CT, Hansen T, Stallknecht B. Structured exercise alters the gut microbiota in humans with overweight and obesity-A randomized controlled trial. Int J Obes (Lond). 2020 Jan;44(1):125-135. doi: 10.1038/s41366-019-0440-y. Epub 2019 Aug 29.'}, {'pmid': '31089425', 'type': 'DERIVED', 'citation': 'Quist JS, Rosenkilde M, Gram AS, Blond MB, Holm-Petersen D, Hjorth MF, Stallknecht B, Sjodin A. Effects of Exercise Domain and Intensity on Sleep in Women and Men with Overweight and Obesity. J Obes. 2019 Apr 7;2019:2189034. doi: 10.1155/2019/2189034. eCollection 2019.'}, {'pmid': '30878970', 'type': 'DERIVED', 'citation': 'Blond MB, Rosenkilde M, Gram AS, Tindborg M, Christensen AN, Quist JS, Stallknecht BM. How does 6 months of active bike commuting or leisure-time exercise affect insulin sensitivity, cardiorespiratory fitness and intra-abdominal fat? A randomised controlled trial in individuals with overweight and obesity. Br J Sports Med. 2019 Sep;53(18):1183-1192. doi: 10.1136/bjsports-2018-100036. Epub 2019 Mar 16.'}, {'pmid': '28993707', 'type': 'DERIVED', 'citation': 'Quist JS, Rosenkilde M, Petersen MB, Gram AS, Sjodin A, Stallknecht B. Effects of active commuting and leisure-time exercise on fat loss in women and men with overweight and obesity: a randomized controlled trial. Int J Obes (Lond). 2018 Mar;42(3):469-478. doi: 10.1038/ijo.2017.253. Epub 2017 Oct 10.'}, {'pmid': '28679486', 'type': 'DERIVED', 'citation': 'Gram AS, Bladbjerg EM, Quist JS, Petersen MB, Rosenkilde M, Stallknecht B. Anti-inflammatory effects of active commuting and leisure time exercise in overweight and obese women and men: A randomized controlled trial. Atherosclerosis. 2017 Oct;265:318-324. doi: 10.1016/j.atherosclerosis.2017.06.923. Epub 2017 Jun 28.'}]}, 'descriptionModule': {'briefSummary': 'The aim of present randomized controlled trial is to evaluate the health effects of physical activity in transport and leisure time domains of everyday life and to develop durable physical activity regimens, i.e. to go from lifestyle intervention to daily lifestyle routine, in overweight individuals.\n\nSubjects will be randomized to 1 of 4 groups. 1: Vigorous intensity leisure time physical activity, 2: Moderate intensity leisure time activity, 3: Active commuting by bicycle, or 4: a non-intervention control group'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* No engagement in habitual structured physical activity\n* Body mass index 25-35 kg/m2\n* Body fat percentage \\>32% for women and \\>25% for men\n* Maximum oxygen uptake (VO2max) \\<40 ml O2/kg/min for women and \\<45 ml O2/kg/min for men\n* Ethnicity: Caucasian\n\nExclusion Criteria:\n\n* Chronic use of medicine\n* Smoking\n* Fasting plasma glucose \\> 6,1 mmol/L\n* Blood pressure \\> 140/90 mm Hg\n* Abnormal resting and working ECG\n* Parents or siblings with diagnosed type 2 diabetes\n* For women: Follicle stimulating hormone (FSH) concentration \\> 35 milliunits/ml, pregnancy or planning of pregnancy within the coming year'}, 'identificationModule': {'nctId': 'NCT01962259', 'acronym': 'GO-ACTIWE', 'briefTitle': 'Active Commuting To Improve Well-being and Health in Everyday Life', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Active Commuting To Improve Well-being and Health in Everyday Life', 'orgStudyIdInfo': {'id': 'ACTIWE-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vigorous intensity LTPA', 'description': 'Leisure time physical activity (LTPA): Exercise intensity: 70% of maximal oxygen uptake (VO2 max); Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week', 'interventionNames': ['Behavioral: Physical activity']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate intensity LTPA', 'description': 'Leisure time physical activity (LTPA): Exercise intensity: 50% VO2 max; Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week', 'interventionNames': ['Behavioral: Physical activity']}, {'type': 'EXPERIMENTAL', 'label': 'Active commuting', 'description': 'Bicycling to/from work/school/university. No requirements for exercise intensity; Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week; Avg distance per day Females 9-15 km; Males 11-17 km', 'interventionNames': ['Behavioral: Physical activity']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Receives no intervention.'}], 'interventions': [{'name': 'Physical activity', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Active commuting', 'Moderate intensity LTPA', 'Vigorous intensity LTPA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2200', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'University of Copenhagen, Department of Biomedical Sciences', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Bente M Stallknecht, MD,PHD,DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen, Department of Biomedical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Copenhagen University Hospital, Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Bente Merete Stallknecht', 'investigatorAffiliation': 'University of Copenhagen'}}}}