Effect of Resistance Training on Musculoskeletal Endocrine Interactions

NCT02040727 | Completed

• 1 other identifier: COMB
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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. In 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

Conditions

Musculoskeletal and Metabolic Crosstalk

Keywords

Myokines; Osteokines; Glucose homeostasis; Puberty

Outcome Measures

Primary Outcomes (4)

• Fasting plasma FGF-23 concentration

  Fibroblast Growth Factor-23

  0,8,12,16, 24 weeks

• Fasting serum osteocalcin concentration

  0, 8, 12, 16, 24 weeks

• Fasting serum insulin concentration

  0, 8, 12, 16, 24 weeks

• Fasting serum glucose concentration

  0, 8, 12, 16, 24 weeks

Secondary Outcomes (4)

• Bone mineral content

  0, 12, 24 weeks

• Muscle strength

  0, 8, 12, 16, 24 weeks

• Muscle density

  0, 12, 24 weeks

• Bone stress-strain index

  0, 12, 24 weeks

Other Outcomes (3)

• Resting energy expenditure

  0, 12, 24 weeks

• Total fat mass

  0, 12, 24 weeks

• Total lean mass

  0, 12, 24 weeks

Study Arms (2)

Non-Resistance Trained

ACTIVE COMPARATOR

No Participation in Resistance Training

Behavioral: No Resistance Training

Resistance Trained

EXPERIMENTAL

Participation in Resistance Training

Behavioral: Resistance Training

Interventions

Resistance Training BEHAVIORAL

Supervised strength training 3 days per week for 24 weeks

Resistance Trained

No Resistance Training BEHAVIORAL

No supervised strength training throughout the study

Non-Resistance Trained

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• overweight
• early pubertal boys (Tanner stage \<3)
• ages 7-12 years
• self-identified as Non-Hispanic Black.

You may not qualify if:

• type 1 or 2 diabetes
• musculoskeletal disorders
• disturbances in glucose or lipid metabolism
• use of thyroid medication, diuretics, beta-blockers, or any medication that potentially could affect body composition, the lipid profile, insulin sensitivity, or blood pressure
• allergy to EMLA cream
• history of eating disorders, cancer, kidney disease, endocrinopathy, liver disease, heart disease, or thyroid disease
• medically determined not to be able to engage in resistance training

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• 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.

  PMID: 25841541 DERIVED

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Orlando M Gutierrez, MD, MMSc

  University of Alabama at Birmingham

  STUDY DIRECTOR

• Lynae J Hanks, PhD, RD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Krista Casazza, PhD, RD

  University of Alabama at Birmingham

  STUDY DIRECTOR

• Marcas Bamman, PhD

  University of Alabama at Birmingham

  STUDY DIRECTOR

• Ambika Ashraf, MD

  University of Alabama at Birmingham

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-Doctoral Fellow

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: January 20, 2014
• Study Start: October 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 17, 2015

Record last verified: 2015-04

Locations

US (1)