Effects of Jumping on Bone Health in Young Women
Primary Purpose
Osteoporosis, Osteopenia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Jump
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis, Osteopenia focused on measuring jumping, bone health
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
No Intervention
Arm Label
Group 1
Group 2
Group 3
Group 4
Group 5
Group 6
Group 7
Group 8
Group 9
Group 10
Arm Description
10-cm step, 10 reps
10-cm step, 50 reps
10-cm step, 100 reps
20-cm step, 10 reps
20-cm step, 50 reps
20-cm step, 100 reps
30-cm step, 10 reps
30-cm step, 50 reps
30-cm step, 100 reps
Control
Outcomes
Primary Outcome Measures
Bone mineral density
Bone mineral density using dual-energy X-ray absorptiometry (DXA)
Secondary Outcome Measures
Bone remodeling
Bone formation and resorption markers in blood
Bone strength
Femur strength Index (FSI) calculated from DXA scan
Full Information
NCT ID
NCT03413540
First Posted
January 21, 2018
Last Updated
July 24, 2019
Sponsor
California State University, San Marcos
1. Study Identification
Unique Protocol Identification Number
NCT03413540
Brief Title
Effects of Jumping on Bone Health in Young Women
Official Title
Dose-Dependent Effects of Jumping on Bone Health in Premenopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 28, 2008 (Actual)
Primary Completion Date
June 13, 2012 (Actual)
Study Completion Date
June 13, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
California State University, San Marcos
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the longitudinal, dose-dependent effects of jumping on bone health in young women. The women will be divided into 9 groups of varying jump height and repetitions, with a tenth group serving as control.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Osteopenia
Keywords
jumping, bone health
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
357 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
10-cm step, 10 reps
Arm Title
Group 2
Arm Type
Experimental
Arm Description
10-cm step, 50 reps
Arm Title
Group 3
Arm Type
Experimental
Arm Description
10-cm step, 100 reps
Arm Title
Group 4
Arm Type
Experimental
Arm Description
20-cm step, 10 reps
Arm Title
Group 5
Arm Type
Experimental
Arm Description
20-cm step, 50 reps
Arm Title
Group 6
Arm Type
Experimental
Arm Description
20-cm step, 100 reps
Arm Title
Group 7
Arm Type
Experimental
Arm Description
30-cm step, 10 reps
Arm Title
Group 8
Arm Type
Experimental
Arm Description
30-cm step, 50 reps
Arm Title
Group 9
Arm Type
Experimental
Arm Description
30-cm step, 100 reps
Arm Title
Group 10
Arm Type
No Intervention
Arm Description
Control
Intervention Type
Other
Intervention Name(s)
Jump
Intervention Description
Drop jump from step
Primary Outcome Measure Information:
Title
Bone mineral density
Description
Bone mineral density using dual-energy X-ray absorptiometry (DXA)
Time Frame
Change from baseline bone mineral density at 9 months
Secondary Outcome Measure Information:
Title
Bone remodeling
Description
Bone formation and resorption markers in blood
Time Frame
Change from baseline bone formation and resorption markers at 9 months
Title
Bone strength
Description
Femur strength Index (FSI) calculated from DXA scan
Time Frame
Change from baseline femur strength index at 9 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pre-menopausal women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kara A Witzke, PhD
Organizational Affiliation
Oregon State University - Cascades
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effects of Jumping on Bone Health in Young Women
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