Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2026-04-13 @ 10:59 PM
Study NCT ID:
NCT02040727
Status:
COMPLETED
Last Update Posted:
2015-04-17
First Post:
2013-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Resistance Training on Musculoskeletal Endocrine Interactions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-16', 'studyFirstSubmitDate': '2013-12-10', 'studyFirstSubmitQcDate': '2014-01-15', 'lastUpdatePostDateStruct': {'date': '2015-04-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Resting energy expenditure', 'timeFrame': '0, 12, 24 weeks', 'description': 'by indirect calorimetry'}, {'measure': 'Total fat mass', 'timeFrame': '0, 12, 24 weeks', 'description': 'by DXA'}, {'measure': 'Total lean mass', 'timeFrame': '0, 12, 24 weeks', 'description': 'by DXA'}], 'primaryOutcomes': [{'measure': 'Fasting plasma FGF-23 concentration', 'timeFrame': '0,8,12,16, 24 weeks', 'description': 'Fibroblast Growth Factor-23'}, {'measure': 'Fasting serum osteocalcin concentration', 'timeFrame': '0, 8, 12, 16, 24 weeks'}, {'measure': 'Fasting serum insulin concentration', 'timeFrame': '0, 8, 12, 16, 24 weeks'}, {'measure': 'Fasting serum glucose concentration', 'timeFrame': '0, 8, 12, 16, 24 weeks'}], 'secondaryOutcomes': [{'measure': 'Bone mineral content', 'timeFrame': '0, 12, 24 weeks', 'description': 'by DXA'}, {'measure': 'Muscle strength', 'timeFrame': '0, 8, 12, 16, 24 weeks'}, {'measure': 'Muscle density', 'timeFrame': '0, 12, 24 weeks', 'description': 'by pQCT'}, {'measure': 'Bone stress-strain index', 'timeFrame': '0, 12, 24 weeks', 'description': 'by pQCT'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Myokines', 'Osteokines', 'Glucose homeostasis', 'Puberty'], 'conditions': ['Musculoskeletal and Metabolic Crosstalk']}, 'referencesModule': {'references': [{'pmid': '25841541', 'type': 'DERIVED', 'citation': 'Hanks LJ, Gutierrez OM, Ashraf AP, Casazza K. Bone Mineral Content as a Driver of Energy Expenditure in Prepubertal and Early Pubertal Boys. J Pediatr. 2015 Jun;166(6):1397-403. doi: 10.1016/j.jpeds.2015.02.054. Epub 2015 Apr 1.'}]}, 'descriptionModule': {'briefSummary': 'This project will evaluate the impact of resistance training on the synthesis and release of hormones and growth factors from the musculoskeletal system and the extent to which the communicative capacity influences glucose homeostasis In turn, the contribution of glucose regulation on the musculoskeletal system will also be evaluated. This small study will serve as a pilot/feasibility study to define a protocol for implementation of a resistance training intervention in the pediatric population. To establish feasibility, this study population is limited to overweight African American boys ages 7-11 years.\n\nIn light of well-established accolades of resistance training, historical recommendations for avoidance among the pediatric population have deterred implementation of resistance training interventions in young adolescents. However, contemporary data indicating a profound benefit of resistance training to the skeletal system in pre-adolescents has led to the Academy of Sports Medicine, as well as various other pediatric health interest groups, to support supervised programs incorporating resistance training in young children, emphasizing large muscle and core strengthening. To date, such trials have not been conducted in the pediatric population', 'detailedDescription': 'Early adolescence (pre-puberty) is associated with many physiological changes with the intersection of metabolic pathways and body composition at the core. Lifestyle behaviors provide substantial influence and the rise of sedentary behavior particularly among this population can exert profound disruption. Metabolic dysfunction associated with limited activity and thus limited strain on the muscles and bones is associated with poor musculoskeletal health. Metabolic disturbance within the system during critical periods of development such as pre-puberty confers long-term health consequences.\n\nCommunication across systems is reliant upon various hormones which interact on the regulation of glucose homeostasis, bone metabolism, and muscle development. While it is well-established that bone and muscle growth are dependent upon fuel utilization, factors secreted by bone and muscle have been recently shown to play an interactive role in glucose homeostasis. Data derived primarily from animal models have demonstrated maintenance of physiological levels promote optimal growth and development, whereas these hormones appear to have adverse effects when levels are altered. While the data in animals is compelling, translation in humans has not been conducted.\n\nSpeculatively, impaired glucose homeostasis, much attributable to decreased strain on the musculoskeletal system, promotes impairments in physiological roles of these hormones. As a result, disordered development may be of consequence, such that the bones grow bigger yet have impaired quality, and delivery of fuel to muscle is compromised. Obesity-induced perturbations in metabolism and tissue partitioning may be an added stress to the system, impairing muscle function, power, performance and overall quality. Strategies that optimize the protective effects of the musculoskeletal system may be encompassed by forced stress on the system via resistance training, known to influence synthesis and release of hormones involved in fuel delivery and utilization by muscle and bone. The strategy proposed will target optimization of musculoskeletal health, promoting synthesis and release of musculoskeletal-derived signals providing protection on metabolic health at a critical period of development.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* overweight\n* early pubertal boys (Tanner stage \\<3)\n* ages 7-12 years\n* self-identified as Non-Hispanic Black.\n\nExclusion Criteria:\n\n* type 1 or 2 diabetes\n* musculoskeletal disorders\n* disturbances in glucose or lipid metabolism\n* use of thyroid medication, diuretics, beta-blockers, or any medication that potentially could affect body composition, the lipid profile, insulin sensitivity, or blood pressure\n* allergy to EMLA cream\n* history of eating disorders, cancer, kidney disease, endocrinopathy, liver disease, heart disease, or thyroid disease\n* medically determined not to be able to engage in resistance training'}, 'identificationModule': {'nctId': 'NCT02040727', 'acronym': 'COMB', 'briefTitle': 'Effect of Resistance Training on Musculoskeletal Endocrine Interactions', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Communications of Muscle and Bone', 'orgStudyIdInfo': {'id': 'COMB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Non-Resistance Trained', 'description': 'No Participation in Resistance Training', 'interventionNames': ['Behavioral: No Resistance Training']}, {'type': 'EXPERIMENTAL', 'label': 'Resistance Trained', 'description': 'Participation in Resistance Training', 'interventionNames': ['Behavioral: Resistance Training']}], 'interventions': [{'name': 'Resistance Training', 'type': 'BEHAVIORAL', 'description': 'Supervised strength training 3 days per week for 24 weeks', 'armGroupLabels': ['Resistance Trained']}, {'name': 'No Resistance Training', 'type': 'BEHAVIORAL', 'description': 'No supervised strength training throughout the study', 'armGroupLabels': ['Non-Resistance Trained']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Orlando M Gutierrez, MD, MMSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Alabama at Birmingham'}, {'name': 'Lynae J Hanks, PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}, {'name': 'Krista Casazza, PhD, RD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Alabama at Birmingham'}, {'name': 'Marcas Bamman, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Alabama at Birmingham'}, {'name': 'Ambika Ashraf, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Post-Doctoral Fellow', 'investigatorFullName': 'Lynae J. Hanks, PhD. RD', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}