- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03413540
Effects of Jumping on Bone Health in Young Women
Dose-Dependent Effects of Jumping on Bone Health in Premenopausal Women
Study Overview
Detailed Description
Over 1 million hip and spine fractures each year are associated with osteoporosis, a disease of low bone mass that contributes to increased morbidity, mortality and economic strain on our medical system. Effective low-cost prevention strategies such as bone-loading exercise, could lower the incidence of osteoporotic fractures without an increase in medical costs, and provide an alternative to drug therapy. Activity associated with high magnitude forces such as fast running and jumping, have been shown to increase hip bone mass by 1.2%-4% in premenopausal women which may translate into a 20-30% reduction in hip fracture risk. In addition, high impact exercise may also produce benefits that are maintained long-term. However, a specific exercise prescription for improving bone health has not been determined.
To date, no single study has examined the interactive effects of jump magnitude (height) and jump number (repetitions) on bone mineral density by systematically varying the height and number of jumps performed. In addition, no study has evaluated the effects of loading exercise on multiple measures of bone health, in order to quantify the effects of exercise on bone strength, apart from bone mineral density. Determining the optimal dose of jump exercise for improving bone strength will allow the investigators to determine a specific exercise prescription for bone health in premenopausal women and will be useful in future projects that intend to employ jump training to target bone health. The long-term objective of this line of research is to determine how impact loading improves bone quality to ultimately reduce fracture risk.
This study is a randomized, controlled, trial to compare the effects of a 9-month supervised exercise program using three levels of load magnitude (4", 8", 12" jump height) and three load repetitions (10, 50, 100 jumps per session), on three dimensions of bone health (bone density, remodeling and strength) in 300 premenopausal women aged 18-42y. Bone density is the most widely recognized dimension of bone health and clinically accepted index of fracture risk. Bone remodeling reflects the dynamic state of bone and can predict fracture risk independent of bone density. Bone strength, represented by Femur Strength Index, is a reflection of the geometry and structural competence of bone.
Low-cost osteoporosis prevention strategies including jumping exercises, could lower the incidence of osteoporotic fractures without an increase in medical costs, and provide an alternative to drug therapy. This project will allow the investigators to determine the minimum effective dose of jumping exercise required to benefit bone health in premenopausal women and will lead to future research on how exercise improves bone quality and reduces fracture risk.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Premenopausal with a history of regular menses (10-12 cycles/year)
Exclusion Criteria:
- Current smoking
- Obesity (BMI > 30 kg/m2) or underweight (BMI < 18 kg/m2)
- Use of medications known to affect bone metabolism including thyroid hormone, thiazide diuretics, aromatase inhibitors, hormone replacement therapy, selective estrogen receptor modulators (SERMS) and bisphosphonates within the previous 6 months. (Note: Women currently using hormonal birth control (e.g. estrogen, progesterone, depot medroxyprogesterone acetate) for at least the previous 12 months will not be excluded from participation, but will be asked to continue with their current method throughout the study period).
- Chronic disorders that affect bone metabolism and/or the ability to participate in exercise training such as diabetes, hyperparathyroidism, uncontrolled hypothyroidism, balance difficulties, use of narcotic medication.
- Regular participation in exercise associated with a large volume of jumping (i.e., volleyball, basketball, high-impact aerobics, plyometrics, gymnastics, etc) within the past year.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Group 1
10-cm step, 10 reps
|
Drop jump from step
|
|
EXPERIMENTAL: Group 2
10-cm step, 50 reps
|
Drop jump from step
|
|
EXPERIMENTAL: Group 3
10-cm step, 100 reps
|
Drop jump from step
|
|
EXPERIMENTAL: Group 4
20-cm step, 10 reps
|
Drop jump from step
|
|
EXPERIMENTAL: Group 5
20-cm step, 50 reps
|
Drop jump from step
|
|
EXPERIMENTAL: Group 6
20-cm step, 100 reps
|
Drop jump from step
|
|
EXPERIMENTAL: Group 7
30-cm step, 10 reps
|
Drop jump from step
|
|
EXPERIMENTAL: Group 8
30-cm step, 50 reps
|
Drop jump from step
|
|
EXPERIMENTAL: Group 9
30-cm step, 100 reps
|
Drop jump from step
|
|
NO_INTERVENTION: Group 10
Control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bone mineral density
Time Frame: Change from baseline bone mineral density at 9 months
|
Bone mineral density using dual-energy X-ray absorptiometry (DXA)
|
Change from baseline bone mineral density at 9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bone remodeling
Time Frame: Change from baseline bone formation and resorption markers at 9 months
|
Bone formation and resorption markers in blood
|
Change from baseline bone formation and resorption markers at 9 months
|
|
Bone strength
Time Frame: Change from baseline femur strength index at 9 months
|
Femur strength Index (FSI) calculated from DXA scan
|
Change from baseline femur strength index at 9 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kara A Witzke, PhD, Oregon State University - Cascades
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1SC3GM084705 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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