Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT00460135
Status:
COMPLETED
Last Update Posted:
2009-03-04
First Post:
2007-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Resistance Exercise Training On Metabolic Dysregulation in Obese Children.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-03', 'studyFirstSubmitDate': '2007-04-11', 'studyFirstSubmitQcDate': '2007-04-12', 'lastUpdatePostDateStruct': {'date': '2009-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in body composition as per DEXA scans', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Changes in insulin resistance as per HOMA score', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Resistance', 'Training', 'Obesity', 'Children'], 'conditions': ['Childhood Obesity', 'Body Composition', 'Resistance Training', 'Insulin Resistance']}, 'descriptionModule': {'briefSummary': 'Impact of resistance training in prepubertal children with obesity focusing mostly in changes in body composition and markers of insulin resistance.\n\nHypothesis is that this will show positive changes in this randomized controlled trial.', 'detailedDescription': '24 obese prepubertal obese children randomized to either resistance training program or usual care for 12 weeks. Baseline blood profiles and DEXA scans done before and after 12 weeks of training with the help of kinesiology graduates from Concordia University kinesiology department.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 8-12y\n* Prepubertal\n* Not on medications with known impact on weight loss\n\nExclusion Criteria:\n\n* Pubertal\n* Uncontrolled thyroid condition\n* Type 2 diabetes'}, 'identificationModule': {'nctId': 'NCT00460135', 'briefTitle': 'The Impact of Resistance Exercise Training On Metabolic Dysregulation in Obese Children.', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'The Impact of Resistance Exercise Training On Metabolic Dysregulation in Obese Children.', 'orgStudyIdInfo': {'id': 'PED-06-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RT', 'description': 'resistance training', 'interventionNames': ['Behavioral: resistance training']}, {'type': 'NO_INTERVENTION', 'label': 'Routine care', 'description': 'General counseling on increasing physical exercise'}], 'interventions': [{'name': 'resistance training', 'type': 'BEHAVIORAL', 'description': '2 times a week resistance training', 'armGroupLabels': ['RT']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3H 1P3', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Montreal Children's Hospital", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Laurent Legault, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Montreal Children's Hospital of the MUHC"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Laurent Legault,MD', 'oldOrganization': 'MUHC'}}}}