Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT06078358
Status:
COMPLETED
Last Update Posted:
2023-10-13
First Post:
2023-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Resistance Exercise Training in Children.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, '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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-10', 'studyFirstSubmitDate': '2023-10-05', 'studyFirstSubmitQcDate': '2023-10-10', 'lastUpdatePostDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from baseline in the fatty acid saturation levels of the extramyocellular lipids of the vastus lateralis, as measure with magnetic resonance spectroscopy', 'timeFrame': 'baseline, following the intervention (9 weeks)', 'description': 'The score will reflect a saturation level of fatty acids in the extramyocellular lipid. The higher score, reflects greater fatty acid saturation.'}, {'measure': 'Change from baseline in the fatty acid saturation levels of the intramyocellular lipids of the vastus lateralis, as measure with magnetic resonance spectroscopy', 'timeFrame': 'baseline, following the intervention (9 weeks)', 'description': 'The score will reflect a saturation level of fatty acids in the intramyocellular lipid. The higher score, reflects greater fatty acid saturation.'}, {'measure': 'Change from baseline in motor unit firing rates during a 35% of maximal voluntary contraction (MVC).', 'timeFrame': 'baseline, following the intervention (9 weeks)', 'description': 'Scores are measured with the y-intercepts from the firing rates versus recruitment threshold relationships from the 35%. The higher y-intercept score reflects greater muscle activation.'}, {'measure': 'Change from baseline in motor unit firing rates during a 35% of maximal voluntary contraction (MVC).', 'timeFrame': 'baseline, following the intervention (9 weeks)', 'description': 'Scores are measured with the slopes from the firing rates versus recruitment threshold relationships from the 35%. The higher slope score reflects greater muscle activation.'}, {'measure': 'Change from baseline in intramyocellular lipids of the vastus lateralis, as measure with magnetic resonance spectroscopy', 'timeFrame': 'baseline, following the intervention (9 weeks)', 'description': 'The score will reflect a concentration. The higher score, reflects more fat in the fibers.'}, {'measure': 'Change from baseline in extramyocellular lipids of the vastus lateralis, as measure with magnetic resonance spectroscopy', 'timeFrame': 'baseline, following the intervention (9 weeks)', 'description': 'The score will reflect a concentration. The higher score, reflects more fat in the fibers.'}], 'primaryOutcomes': [{'measure': 'Change in the muscular strength of leg extensors, as measured with isometric strength.', 'timeFrame': 'baseline, following the intervention (9 weeks)', 'description': 'The score will reflect the strength of the leg extensors. The higher score, reflects greater muscular strength.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in motor unit firing rates during a 60% of maximal voluntary contraction (MVC).', 'timeFrame': 'baseline, following the intervention (9 weeks)', 'description': 'Scores are measured with the y-intercept from the firing rates versus recruitment threshold relationships from the 60%. The higher y-intercept score reflects greater muscle activation.'}, {'measure': 'Change from baseline in motor unit firing rates during a 60% of maximal voluntary contraction (MVC).', 'timeFrame': 'baseline, following the intervention (9 weeks)', 'description': 'Scores are measured with the slope from the firing rates versus recruitment threshold relationships from the 60%. The higher slope score reflects greater muscle activation.'}, {'measure': 'Change from baseline in thigh muscle cross-sectional area.', 'timeFrame': 'baseline, following the intervention (9 weeks)', 'description': 'Scores are measured cross-sectional area from ultrasound images.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exercise', 'muscle cross-sectional area', 'intramyocellular lipids', 'extramyocellular lipids', 'strength'], 'conditions': ['Resistance Training']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is examine the effects of 8 weeks (3 days/week) of resistance exercise training in children 8 to 10 years of age on muscle strength, activation, and lipids of the vastus lateralis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteer males and females ages 8 - 10 years.\n\nExclusion Criteria:\n\n* No history or ongoing neuromuscular diseases, musculoskeletal injuries, or a disease that effects metabolism.'}, 'identificationModule': {'nctId': 'NCT06078358', 'briefTitle': 'Resistance Exercise Training in Children.', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'The Effects of Resistance Exercise on Muscle Activation and Lipids in Children', 'orgStudyIdInfo': {'id': 'STUDY00147248'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Resistance exercise training', 'description': 'Participants undergo 8 weeks (3 days/week) of resistance exercise training.', 'interventionNames': ['Other: Resistance exercise training']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants do not perform 8 weeks of resistance exercise training.'}], 'interventions': [{'name': 'Resistance exercise training', 'type': 'OTHER', 'description': 'Traditional linear periodization resistance training.', 'armGroupLabels': ['Resistance exercise training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66103', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Hoglund Biomedical Imaging Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '66213', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Exercise and Human Performance Laboratory', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '66213', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Metabolic and Body Composition Laboratory', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Energy Balance Laboratory', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}]}, 'ipdSharingStatementModule': {'infoTypes': ['ICF'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Strength and Conditioning Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Trent J. Herda, Ph.D.', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}