Bone and Body Composition Adaptations to Physical Training (NCT06972862) | Clinical Trial Compass
CompletedNot Applicable
Bone and Body Composition Adaptations to Physical Training
United States206 participantsStarted 2022-08-29
Plain-language 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.
Who can participate
Age range18 Years – 40 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
Bone microarchitecture: Change in bone microarchitecture as measured via High Resolution- peripheral Quantitative Computed Tomography, change from baseline, mean
Timeframe: Through study completion, an average of 6 months.
2
Bone strength: Change in bone strength as measured via High Resolution- peripheral Quantitative Computed Tomography, change from baseline, mean
Timeframe: Through study completion, an average of 6 months
✕. 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