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Effects of Jumping on Bone Health in Young Women

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ClinicalTrials.gov Identifier: NCT03413540
Recruitment Status : Completed
First Posted : January 29, 2018
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Kara Witzke, PhD, Oregon State University

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.

Condition or disease Intervention/treatment
Osteoporosis, Osteopenia Other: Jump

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 : Interventional  (Clinical Trial)
Actual Enrollment : 357 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Dose-Dependent Effects of Jumping on Bone Health in Premenopausal Women
Actual Study Start Date : September 28, 2008
Primary Completion Date : June 13, 2012
Study Completion Date : June 13, 2012

Arm Intervention/treatment
Experimental: Group 1
10-cm step, 10 reps
Other: Jump
Drop jump from step
Experimental: Group 2
10-cm step, 50 reps
Other: Jump
Drop jump from step
Experimental: Group 3
10-cm step, 100 reps
Other: Jump
Drop jump from step
Experimental: Group 4
20-cm step, 10 reps
Other: Jump
Drop jump from step
Experimental: Group 5
20-cm step, 50 reps
Other: Jump
Drop jump from step
Experimental: Group 6
20-cm step, 100 reps
Other: Jump
Drop jump from step
Experimental: Group 7
30-cm step, 10 reps
Other: Jump
Drop jump from step
Experimental: Group 8
30-cm step, 50 reps
Other: Jump
Drop jump from step
Experimental: Group 9
30-cm step, 100 reps
Other: Jump
Drop jump from step
No Intervention: Group 10
Control



Primary Outcome Measures :
  1. Bone mineral density [ Time Frame: Change from baseline bone mineral density at 9 months ]
    Bone mineral density using dual-energy X-ray absorptiometry (DXA)


Secondary Outcome Measures :
  1. Bone remodeling [ Time Frame: Change from baseline bone formation and resorption markers at 9 months ]
    Bone formation and resorption markers in blood

  2. Bone strength [ Time Frame: Change from baseline femur strength index at 9 months ]
    Femur strength Index (FSI) calculated from DXA scan



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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pre-menopausal women
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03413540


Sponsors and Collaborators
Oregon State University
Investigators
Principal Investigator: Kara A Witzke, PhD Oregon State University - Cascades

Responsible Party: Kara Witzke, PhD, Assistant Dean, Oregon State University
ClinicalTrials.gov Identifier: NCT03413540     History of Changes
Other Study ID Numbers: 1SC3GM084705 ( U.S. NIH Grant/Contract )
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kara Witzke, PhD, Oregon State University:
jumping
bone health

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases