Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-05 @ 5:57 PM
Study NCT ID:
NCT01313468
Status:
COMPLETED
Last Update Posted:
2017-03-30
First Post:
2011-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interval Training and Resting Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-29', 'studyFirstSubmitDate': '2011-03-10', 'studyFirstSubmitQcDate': '2011-03-10', 'lastUpdatePostDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'nonexercise activity thermogenesis', 'timeFrame': 'Baseline and 10 weeks', 'description': 'NEAT Will be measured using an activity sensor. Physical activity is recorded over a 7 day period. The energy equivalent of each of these activities is determined. The time spent in each activity is then multiplied by equivalent for the activity. The values are then summed to derive an estimate of NEAT.'}], 'secondaryOutcomes': [{'measure': 'Cardiopulmonary maximal oxygen uptake', 'timeFrame': 'Baseline and 10 weeks', 'description': 'The secondary aims are to investigate the changes in maximal oxygen uptake, heart function, and body composition in response to interval training'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NEAT', 'maximal oxygen uptake', 'stroke volume'], 'conditions': ['Healthy Subjects']}, 'referencesModule': {'references': [{'pmid': '25969700', 'type': 'RESULT', 'citation': 'Zisko N, Stensvold D, Hordnes-Slagsvold K, Rognmo O, Nauman J, Wisloff U, Karlsen T. Effect of Change in VO2max on Daily Total Energy Expenditure in a Cohort of Norwegian Men: A Randomized Pilot Study. Open Cardiovasc Med J. 2015 Apr 30;9:50-7. doi: 10.2174/1874192401509010050. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'It has been reported that obese individuals are seated 2 ½ hour more than lean individuals and that non exercise thermo genesis (NEAT) may vary with as much as 2000 Kcal/day between equal size people due to different occupational and leisure time activities. The primary aim of the study is to investigate if 10 weeks of exercise training increase NEAT in sedentary men.\n\nSubject will be randomized to three different training intervention, with 3 exercise session each week for 10 weeks. NEAT will be measured using an activity sensor and recorded over a 7 day period both before and after training.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male gender\n* Age 18-50\n* BMI 25-30 kg x m2\n* No significant comorbidities\n* Abel to exercise\n* Not partaking in organized physical activity\n\nExclusion Criteria:\n\n* Inability to exercise due to musculoskeletal conditions\n* Known ischemic cardiovascular disease\n* High daily physical and occupational activity levels'}, 'identificationModule': {'nctId': 'NCT01313468', 'acronym': 'NEAT', 'briefTitle': 'Interval Training and Resting Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Effect of Aerobic Interval Training on NEAT in Sedentary Men', 'orgStudyIdInfo': {'id': '2010/1541'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '4 x 4 Interval', 'description': '4 x 4 minutes of high intensity intervals at 90-95% of maximal heart rate separated by 3 minutes of active brakes in between at 70% of maximal heart rate.', 'interventionNames': ['Behavioral: 4 x 4 minutes Intervals']}, {'type': 'EXPERIMENTAL', 'label': '1 4 minutes interval', 'description': '1 x 4 minutes intervals at 90-95% of HR max', 'interventionNames': ['Behavioral: 1 x 4 minute interval']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate continuous Training', 'description': '47 minutes of Moderate continuous Training', 'interventionNames': ['Behavioral: Moderate continuous Training']}], 'interventions': [{'name': '1 x 4 minute interval', 'type': 'BEHAVIORAL', 'description': '1 x 4 minutes of high intensity intervals at 90-95% of maximal heart rate', 'armGroupLabels': ['1 4 minutes interval']}, {'name': '4 x 4 minutes Intervals', 'type': 'BEHAVIORAL', 'description': '4 x 4 minutes of high intensity intervals at 90-95% of maximal heart rate separated by 3 minutes of active brakes in between at 70% of maximal heart rate.', 'armGroupLabels': ['4 x 4 Interval']}, {'name': 'Moderate continuous Training', 'type': 'BEHAVIORAL', 'description': '47 minutes of Moderate continuous Training', 'armGroupLabels': ['Moderate continuous Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7491', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'NTNU', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Trine Karlsen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan Normal University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Olavs Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}