Bone and Body Composition Adaptations to Physical Training
NCT ID: NCT06972862
Last Updated: 2025-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
206 participants
INTERVENTIONAL
2022-08-29
2025-04-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Parameters of Exercise to Prevent Osteoporosis
NCT04063813
Efficacy of Plyometrics to Increase Bone Mass in Men With Osteopenia
NCT00572104
Hormonal and Bone Turnover Marker Response to an Acute Bout of Resistance or Plyometric Exercise
NCT00572871
Mode of Exercise and Bone Biomarkers in Older Veterans
NCT05266976
Effects of OsteoStrong vs. Individually Adapted and Combined Training on Bone Health
NCT05721014
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Additionally, the research team seeks to determine the physiological responses and adaptations to training that contribute to improved bone health by evaluating changes in hormones, factors released from active skeletal muscle, and body composition. Our hypothesis is that exercise programs emphasizing frequent, high impact loading will cause greater improvements in bone health. Additionally, we believe that exercise training can induce specific changes in hormones, skeletal muscle released signaling factors and body composition that contribute to these bone adaptations.
Participants who enrolled in this study were randomized to either an exercise training group or a control group who were instructed to maintain their current level of exercise and track this to report to the study team. Study completers were those who complied with the parameters of the group they were assigned and reported to all 7 testing visits.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Laboratory Based Osteogenic Index (OI) Optimized Training Group
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.
Osteogenic Index Optimized Exercise Training Program
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.
Laboratory Based Control Group
The control group will maintain their habitual exercise, diet, and sleep patterns, all of which will be monitored throughout the study.
No interventions assigned to this group
Reserve Officer Training Corps (ROTC): Observational Group
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Osteogenic Index Optimized Exercise Training Program
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Body mass index (BMI) 18-28 kg/m2
3. Weight stable (±10 lbs) in past 2 months
4. Takes part in moderate physical activity for at least 150 minutes/week
5. Currently free of upper or lower body /extremity injury or impairment
6. Comfortable with multiple blood draws
7. Able to commit to the 6-month study duration
8. Agrees to adhere to study requirements.
Exclusion Criteria
2. Current clinical diagnosis of an eating disorder
3. 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.
4. 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
5. Current oligo/amenorrhea in women, not explained by contraceptive use
6. Any metabolic or endocrine disease that affects bone; Individuals taking hormonal therapy for transgender care
7. Currently training for a competitive sporting event or planning to start
8. Weight has fluctuated by 10 pounds or more in the past 2 months based on subject self-report
9. Has been diagnosed with a medical condition, physical or psychological, that currently prevents exercise participation
10. Has suffered a musculoskeletal injury removing them from physical activity for more than a month, within the past two years
11. Currently pregnant or becomes pregnant during the study (as assessed by urine pregnancy tests at 0, 3 \& 6 months)
12. 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)
13. History of heart condition OR high blood pressure
14. Feeling of pain in the chest during rest, activities of daily living, or physical activity
15. Have lost balance or consciousness due to dizziness in the last 12 months (with the exception of dizziness due to hyperventilation)
16. Treating physician requires subject participates in medically supervised physical activity only
17. History of drug addiction or habitual recreational drug use (2 or more times per month in each of the previous six months)
18. Low bone mineral density indicated as a Z-score \<-1.0 measured by dual-energy x-ray absorptiometry (DXA)
18 Years
40 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
U.S. Army Medical Research and Development Command
FED
University of Pittsburgh
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bradley Nindl
Professor and Vice Chair for Research, Department of Sports Medicine and Nutrition, University of Pittsburgh; Director, Neuromuscular Research Laboratory/Warrior Human Performance Research Center
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kristen J Koltun, PhD
Role: STUDY_DIRECTOR
University of Pittsburgh
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Kansas, Jayhawk Performance Laboratory
Lawrence, Kansas, United States
Neuromuscular Research Laboratory
Pittsburgh, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Allaway HC, Williams NI, Mallinson RJ, Koehler K, De Souza MJ. Reductions in urinary collection frequency for assessment of reproductive hormones provide physiologically representative exposure and mean concentrations when compared with daily collection. Am J Hum Biol. 2015 May-Jun;27(3):358-71. doi: 10.1002/ajhb.22649. Epub 2014 Oct 29.
Nindl BC, Urso ML, Pierce JR, Scofield DE, Barnes BR, Kraemer WJ, Anderson JM, Maresh CM, Beasley KN, Zambraski EJ. IGF-I measurement across blood, interstitial fluid, and muscle biocompartments following explosive, high-power exercise. Am J Physiol Regul Integr Comp Physiol. 2012 Nov 15;303(10):R1080-9. doi: 10.1152/ajpregu.00275.2012. Epub 2012 Aug 29.
Lester ME, Urso ML, Evans RK, Pierce JR, Spiering BA, Maresh CM, Hatfield DL, Kraemer WJ, Nindl BC. Influence of exercise mode and osteogenic index on bone biomarker responses during short-term physical training. Bone. 2009 Oct;45(4):768-76. doi: 10.1016/j.bone.2009.06.001. Epub 2009 Jun 9.
Carson JA, Manolagas SC. Effects of sex steroids on bones and muscles: Similarities, parallels, and putative interactions in health and disease. Bone. 2015 Nov;80:67-78. doi: 10.1016/j.bone.2015.04.015.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form
Related Links
Access external resources that provide additional context or updates about the study.
Neuromuscular Research Laboratory Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
W81XWH-21-1-0542
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
STUDY21020044
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.