Status:
COMPLETED
Bone and Body Composition Adaptations to Physical Training
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
U.S. Army Medical Research and Development Command
Conditions:
Exercise
Healthy
Eligibility:
All Genders
18-40 years
Phase:
NA
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 skele...
Detailed Description
The overall objective of this study is to determine the bone density, structure and strength adaptations that result from various exercise programs which differ based on the frequency and intensity of...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
- Treating physician requires subject participates in medically supervised physical activity only
- History of drug addiction or habitual recreational drug use (2 or more times per month in each of the previous six months)
- Low bone mineral density indicated as a Z-score \<-1.0 measured by dual-energy x-ray absorptiometry (DXA)
Key Trial Info
Start Date :
August 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2025
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT06972862
Start Date
August 29 2022
End Date
April 27 2025
Last Update
May 15 2025
Active Locations (2)
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1
University of Kansas, Jayhawk Performance Laboratory
Lawrence, Kansas, United States, 66045
2
Neuromuscular Research Laboratory
Pittsburgh, Pennsylvania, United States, 15203