Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-02-27 @ 12:49 AM
Study NCT ID:
NCT02215603
Status:
UNKNOWN
Last Update Posted:
2016-01-13
First Post:
2014-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Disrupting Prolonged Sitting With Different Physical Activity Protocols on Metabolic Risk Factors in Sedentary Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-12', 'studyFirstSubmitDate': '2014-08-07', 'studyFirstSubmitQcDate': '2014-08-11', 'lastUpdatePostDateStruct': {'date': '2016-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Area under the curve of cytokine postprandial responses', 'timeFrame': '27 h', 'description': 'Cytokine levels (TNF-alpha, IL-6, IL-10, and IL1-ra) will be assessed 10 min before, and 30, 60, 120 and 180 min after each main meal. These postprandial responses will be defined as the area under the curve (AUC) assessed over the 3-h period after each main meal (3-h AUC) and the cumulative AUC after all main meals (12-h AUC).'}], 'primaryOutcomes': [{'measure': 'Area under the curve of glucose and insulin postprandial responses', 'timeFrame': '27 h', 'description': 'Glucose and insulin levels will be assessed 10 min before, and 30, 60, 120 and 180 min after each main meal. These postprandial responses will be defined as the area under the curve (AUC) assessed over the 3-h period after each main meal (3-h AUC) and the cumulative AUC after all main meals (12-h AUC).'}], 'secondaryOutcomes': [{'measure': 'Glucose levels', 'timeFrame': '27 hours', 'description': 'Glucose incursions will measured using the glucose monitoring (CGM) system throughout the 27 hours. Mean, maximum and minimum glucose values during the 27h will be the outcome measures (mmol/l).'}, {'measure': 'Area under the curve of lipid postprandial responses', 'timeFrame': '27 h', 'description': 'Lipid levels will be assessed 10 min before, and 30, 60, 120 and 180 min after each main meal. These postprandial responses will be defined as the area under the curve (AUC) assessed over the 3-h period after each main meal (3-h AUC) and the cumulative AUC after all main meals (12-h AUC).'}]}, 'conditionsModule': {'conditions': ['Prolonged Sitting', 'Breaking Prolonged Sitting With Physical Activity']}, 'descriptionModule': {'briefSummary': 'Great controversy exists with respect to the optimal or the minimum volume, intensity, and frequency of physical activity capable of attenuating the hazards of prolonged sitting on the metabolic profile. Thus, our study aims to comprehensively investigate the effects of disrupting prolonged sitting with different physical activity protocols on metabolic risk factors in sedentary males.\n\nTen sedentary males will take part in this randomized cross-over trial consisting of four 27-h conditions. All conditions will be identical except for the physical activity: prolonged sitting intervention (SIT) participants will sit continuously for 9 hours; prolonged sitting+interval standing intervention (STAND), participants will stand for 15 min every 30 minutes (total 270 min) during the 9 hours of sitting; prolonged sitting+moderate-intensity exercise bout (MVPA) participants will perform a 30-min moderate-intensity exercise bout on a treadmill (energy-matched to STAND), after which they will sit for the remaining time; and prolonged sitting+moderate-intensity exercise bout +interval standing intervention (MVPA-STAND), participants will perform a 30-min moderate-intensity exercise bout on a treadmill (energy-matched to STAND), after which they will stand for 15 min every 30 minutes (total 240 min) during the remaining 8 hours of sitting. Blood glucose, insulin, lipids and cytokines will be determined.\n\nThe investigators expect that disrupting prolonged sitting with intermittent standing and a moderate-exercise bout will positively affect the metabolic profile of the participants. Furthermore, we will investigate if combined, these strategies will have an additive effect.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males,\n* age 25-55 y,\n* BMI \\>18 and \\<35 kg/m2\n\nExclusion Criteria:\n\n* Clinically diagnosed diabetes,\n* dyslipidaemia,\n* hypertension,\n* use of glucose- and/or lipid-lowering medication,\n* smoking,\n* evidence of thyroid, liver, lung, heart or kidney disease,\n* non-sedentary occupation and primary means of commuting to work (i.e., cycling) in the last 4 months,\n* VO2max levels above the considered average fitness according to age,\n* contraindication to increased levels of physical activity.'}, 'identificationModule': {'nctId': 'NCT02215603', 'briefTitle': 'Effects of Disrupting Prolonged Sitting With Different Physical Activity Protocols on Metabolic Risk Factors in Sedentary Adults', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'orgStudyIdInfo': {'id': 'ProlongedSitting'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Prolonged sitting', 'description': '9 h of prolonged sitting'}, {'type': 'EXPERIMENTAL', 'label': 'Prolonged sitting + interval standing bouts', 'description': 'Stand bout for 15-min every 30 minutes during the 9 hours of sitting', 'interventionNames': ['Behavioral: Breaking prolonged sitting with physical activity']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate exercise bout + Prolonged sitting', 'description': '30-min moderate-intensity exercise bout followed by 8 h of sitting', 'interventionNames': ['Behavioral: Breaking prolonged sitting with physical activity']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate exercise bout + Prolonged sitting +Standing bouts', 'description': '30-min moderate-intensity exercise bout and stand bout for 15-min every 30 minutes during the remaining 8 hours of sitting', 'interventionNames': ['Behavioral: Breaking prolonged sitting with physical activity']}], 'interventions': [{'name': 'Breaking prolonged sitting with physical activity', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Moderate exercise bout + Prolonged sitting', 'Moderate exercise bout + Prolonged sitting +Standing bouts', 'Prolonged sitting + interval standing bouts']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Inge Holm', 'role': 'CONTACT'}, {'name': 'Bente Pedersen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Fabiana Benatti, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre of Inflammation and Metabolism', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Fabiana Benatti', 'role': 'CONTACT', 'email': 'fabiana.braga.benatti@regionh.dk', 'phone': '+45 35450898'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Anders Rasmussen Rinnov', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}