Bone and Body Composition Adaptations to Physical Training

NCT06972862 | Completed

• 2 other identifiers: STUDY21020044W81XWH-21-1-0542
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to evaluate how different exercise programs alter bone density, structure, and strength in adults. It will also collect data on hormones, factors released from skeletal muscle, and body composition. The main questions it aims to answer are:

• Do exercise programs that are frequent with high-impact loading will cause greater improvements in bone health?
• What changes in hormones, factors released from skeletal muscle, and body composition contribute to bone adaptations? Researchers will compare different exercise groups to see if the type of exercise influences bone adaptation compared to a recreationally active control group. Participants are asked to:
• complete questionnaires, 5 blood draws across the study (3 at rest, 2 after strenuous exercise), dual energy x-ray absorptiometry (DXA) scans (to assess bone mineral density and body composition), high resolution tibial scans to assess bone structure and geometry, and physical performance testing.
• attend up to 7 testing visits.
• (for those randomized to the exercise training intervention) participate in exercise training sessions for 6 months.

Conditions

Exercise; Healthy

Keywords

bone health; body composition; skeletal muscle; hormones; exercise intervention; recreational athletes; bone marrow adipose tissue; bone formation; bone resportion; bone geometry; bone microarchitecture; bone mineral density

Outcome Measures

Primary Outcomes (2)

• Bone microarchitecture: Change in bone microarchitecture as measured via High Resolution- peripheral Quantitative Computed Tomography, change from baseline, mean

  Through study completion, an average of 6 months.

• Bone strength: Change in bone strength as measured via High Resolution- peripheral Quantitative Computed Tomography, change from baseline, mean

  Through study completion, an average of 6 months

Secondary Outcomes (8)

• Biochemical: Change in concentration of Bone alkaline phosphatase (BAP), change from baseline, mean

  Through study completion, an average of 6 months

• Biochemical: Change in concentration of Procollagen type I N-terminal Propeptide (P1NP), change from baseline, mean

  Through study completion, an average of 6 months

• Biochemical: Change in concentration of Tartrate-resistant acid phosphatase 5b (TRAP5b), change from baseline, mean

  Through study completion, an average of 6 months

• Biochemical: Change in concentration of Beta Cross-linking Telopeptide of type I (B-CTx) collagen, change form baseline, mean

  Through study completion, an average of 6 months

• Bone characteristics: Change in amount of Bone Marrow Adipose Tissue, change from baseline, mean

  Through study completion, an average of 6 months

Other Outcomes (2)

• Body composition: Change in Dual Energy X-Ray Absorptiometry lean mass, change from baseline, mean

  Through study completion, an average of 6 months

• Bone characteristics: Change in Areal Bone Mineral Density, change from baseline, mean

  Through study completion, an average of 6 months

Study Arms (3)

Laboratory Based Osteogenic Index (OI) Optimized Training Group

EXPERIMENTAL

The OI- Optimized Training Group will involve 6 months of planned, non-linear periodized training on a leg press machine called the PPM (Athletic Republic, Salt Lake City, UT) with a maintenance program during the semester breaks, as necessary.

Other: Osteogenic Index Optimized Exercise Training Program

Laboratory Based Control Group

NO INTERVENTION

The control group will maintain their habitual exercise, diet, and sleep patterns, all of which will be monitored throughout the study.

Reserve Officer Training Corps (ROTC): Observational Group

NO INTERVENTION

The ROTC group is made up of Reserve Officer Training Corps participants who are attending a university while concurrently undergoing militaristic training. This group will maintain their physical training as part of their program, diet, and sleep patterns which are monitored throughout the study.

Interventions

Osteogenic Index Optimized Exercise Training Program OTHER

The OI- Optimized Training is 6 months of planned, non-linear periodized training on a leg press machine called the PPM (Athletic Republic, Salt Lake City, UT) with a maintenance program during the semester breaks, as necessary.

Also known as: Exercise Intervention

Laboratory Based Osteogenic Index (OI) Optimized Training Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-40 years
• Body mass index (BMI) 18-28 kg/m2
• Weight stable (±10 lbs) in past 2 months
• Takes part in moderate physical activity for at least 150 minutes/week
• Currently free of upper or lower body /extremity injury or impairment
• Comfortable with multiple blood draws
• Able to commit to the 6-month study duration
• Agrees to adhere to study requirements.

You may not qualify if:

• Current smoker
• Current clinical diagnosis of an eating disorder
• Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs). NSAID use is defined as chronic if these medications are taken more than three times a week for more than 12 consecutive weeks.
• Use of medication incompatible with measurement of reproductive, metabolic, or bone-related hormones (including thyroid medications, glucocorticoids) or which includes anti-coagulants and may interfere with any of the study outcomes
• Current oligo/amenorrhea in women, not explained by contraceptive use
• Any metabolic or endocrine disease that affects bone; Individuals taking hormonal therapy for transgender care
• Currently training for a competitive sporting event or planning to start
• Weight has fluctuated by 10 pounds or more in the past 2 months based on subject self-report
• Has been diagnosed with a medical condition, physical or psychological, that currently prevents exercise participation
• Has suffered a musculoskeletal injury removing them from physical activity for more than a month, within the past two years
• Currently pregnant or becomes pregnant during the study (as assessed by urine pregnancy tests at 0, 3 \& 6 months)
• Current asthma diagnosis, defined as experienced symptoms or been prescribed any form of treatment within the last 4 years, or those who have required more than one course of oral steroids or more than one nebulization since the age of 5 (JSP 950), will require a note/permission from treating physician to participate in study. Those who have had a single admission to intensive care or high dependency, or multiple admissions to hospital will be excluded from participating (JSP 950)
• History of heart condition OR high blood pressure
• Feeling of pain in the chest during rest, activities of daily living, or physical activity
• Have lost balance or consciousness due to dizziness in the last 12 months (with the exception of dizziness due to hyperventilation)

Sponsors & Collaborators

• University of Pittsburgh: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (2)

University of Kansas, Jayhawk Performance Laboratory

Lawrence, Kansas, 66045, United States

Location

Neuromuscular Research Laboratory

Pittsburgh, Pennsylvania, 15203, United States

Location

Related Publications (15)

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  PMID: 26453497 BACKGROUND

• Wentz L, Liu PY, Haymes E, Ilich JZ. Females have a greater incidence of stress fractures than males in both military and athletic populations: a systemic review. Mil Med. 2011 Apr;176(4):420-30. doi: 10.7205/milmed-d-10-00322.

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• Rantalainen T, Nikander R, Heinonen A, Cervinka T, Sievanen H, Daly RM. Differential effects of exercise on tibial shaft marrow density in young female athletes. J Clin Endocrinol Metab. 2013 May;98(5):2037-44. doi: 10.1210/jc.2012-3748. Epub 2013 Apr 24.

  PMID: 23616150 BACKGROUND

• Singhal V, Torre Flores LP, Stanford FC, Toth AT, Carmine B, Misra M, Bredella MA. Differential associations between appendicular and axial marrow adipose tissue with bone microarchitecture in adolescents and young adults with obesity. Bone. 2018 Nov;116:203-206. doi: 10.1016/j.bone.2018.08.009. Epub 2018 Aug 11.

  PMID: 30107255 BACKGROUND

• Gorgey AS, Poarch HJ, Adler RA, Khalil RE, Gater DR. Femoral bone marrow adiposity and cortical bone cross-sectional areas in men with motor complete spinal cord injury. PM R. 2013 Nov;5(11):939-48. doi: 10.1016/j.pmrj.2013.05.006. Epub 2013 May 15.

  PMID: 23684921 BACKGROUND

• Sanford JA, Nogiec CD, Lindholm ME, Adkins JN, Amar D, Dasari S, Drugan JK, Fernandez FM, Radom-Aizik S, Schenk S, Snyder MP, Tracy RP, Vanderboom P, Trappe S, Walsh MJ; Molecular Transducers of Physical Activity Consortium. Molecular Transducers of Physical Activity Consortium (MoTrPAC): Mapping the Dynamic Responses to Exercise. Cell. 2020 Jun 25;181(7):1464-1474. doi: 10.1016/j.cell.2020.06.004.

  PMID: 32589957 BACKGROUND

• Whitham M, Parker BL, Friedrichsen M, Hingst JR, Hjorth M, Hughes WE, Egan CL, Cron L, Watt KI, Kuchel RP, Jayasooriah N, Estevez E, Petzold T, Suter CM, Gregorevic P, Kiens B, Richter EA, James DE, Wojtaszewski JFP, Febbraio MA. Extracellular Vesicles Provide a Means for Tissue Crosstalk during Exercise. Cell Metab. 2018 Jan 9;27(1):237-251.e4. doi: 10.1016/j.cmet.2017.12.001.

  PMID: 29320704 BACKGROUND

• Norheim F, Langleite TM, Hjorth M, Holen T, Kielland A, Stadheim HK, Gulseth HL, Birkeland KI, Jensen J, Drevon CA. The effects of acute and chronic exercise on PGC-1alpha, irisin and browning of subcutaneous adipose tissue in humans. FEBS J. 2014 Feb;281(3):739-49. doi: 10.1111/febs.12619. Epub 2013 Dec 10.

  PMID: 24237962 BACKGROUND

• Robling AG, Niziolek PJ, Baldridge LA, Condon KW, Allen MR, Alam I, Mantila SM, Gluhak-Heinrich J, Bellido TM, Harris SE, Turner CH. Mechanical stimulation of bone in vivo reduces osteocyte expression of Sost/sclerostin. J Biol Chem. 2008 Feb 29;283(9):5866-75. doi: 10.1074/jbc.M705092200. Epub 2007 Dec 17.

  PMID: 18089564 BACKGROUND

• Bonewald LF, Johnson ML. Osteocytes, mechanosensing and Wnt signaling. Bone. 2008 Apr;42(4):606-15. doi: 10.1016/j.bone.2007.12.224. Epub 2008 Jan 12.

  PMID: 18280232 BACKGROUND

• Evans RK, Negus CH, Centi AJ, Spiering BA, Kraemer WJ, Nindl BC. Peripheral QCT sector analysis reveals early exercise-induced increases in tibial bone mineral density. J Musculoskelet Neuronal Interact. 2012 Sep;12(3):155-64.

  PMID: 22947547 BACKGROUND

• Hughes JM, Gaffney-Stomberg E, Guerriere KI, Taylor KM, Popp KL, Xu C, Unnikrishnan G, Staab JS, Matheny RW Jr, McClung JP, Reifman J, Bouxsein ML. Changes in tibial bone microarchitecture in female recruits in response to 8 weeks of U.S. Army Basic Combat Training. Bone. 2018 Aug;113:9-16. doi: 10.1016/j.bone.2018.04.021. Epub 2018 Apr 27.

  PMID: 29709620 BACKGROUND

Related Links

• Neuromuscular Research Laboratory Website

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Kristen J Koltun, PhD

  University of Pittsburgh

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice Chair for Research, Department of Sports Medicine and Nutrition, University of Pittsburgh; Director, Neuromuscular Research Laboratory/Warrior Human Performance Research Center

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 15, 2025
• Study Start: August 29, 2022
• Primary Completion: April 27, 2025
• Study Completion: April 27, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 1 year and ending 5 years following publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. For individual participant data meta-analysis. Proposals should be directed to bnindl@pitt.edu. To gain access, data requesters will need to sign a data access agreement.

Locations

US (2)