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CompletedNCT03413540Updated Jul 26, 2019

Effects of Jumping on Bone Health in Young Women

An interventional study of Jump in Osteoporosis, Osteopenia, sponsored by California State University, San Marcos. Completed. Open to female participants aged 18 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-26.

Sponsored by California State University, San Marcos · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
357
Allocation
Randomized
Ages
18 Years to 42 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Osteoporosis, Osteopenia

Keywords

  • jumping
  • bone health
03

Who can participate

Ages eligible
18 Years to 42 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Premenopausal with a history of regular menses (10-12 cycles/year)

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
357 participants (actual)

Study arms

  • Experimental
    Group 1

    10-cm step, 10 reps

    Other: Jump

  • Experimental
    Group 2

    10-cm step, 50 reps

    Other: Jump

  • Experimental
    Group 3

    10-cm step, 100 reps

    Other: Jump

  • Experimental
    Group 4

    20-cm step, 10 reps

    Other: Jump

  • Experimental
    Group 5

    20-cm step, 50 reps

    Other: Jump

  • Experimental
    Group 6

    20-cm step, 100 reps

    Other: Jump

  • Experimental
    Group 7

    30-cm step, 10 reps

    Other: Jump

  • Experimental
    Group 8

    30-cm step, 50 reps

    Other: Jump

  • Experimental
    Group 9

    30-cm step, 100 reps

    Other: Jump

  • No intervention
    Group 10

    Control

Interventions

  • OtherJump

    Drop jump from step

05

What researchers measure

Primary outcomes

  1. Bone mineral density

    Bone mineral density using dual-energy X-ray absorptiometry (DXA)

    Time frame: Change from baseline bone mineral density at 9 months

Secondary outcomes

  1. Bone remodeling

    Bone formation and resorption markers in blood

    Time frame: Change from baseline bone formation and resorption markers at 9 months

  2. Bone strength

    Femur strength Index (FSI) calculated from DXA scan

    Time frame: Change from baseline femur strength index at 9 months

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03413540
Lead sponsor
California State University, San Marcos
Responsible party
Kara Witzke (Professor, Kinesiology, California State University, San Marcos) — Principal investigator
First posted
Jan 29, 2018
Start date
Sep 28, 2008
Primary completion
Jun 13, 2012
Completion
Jun 13, 2012
Last update
Jul 26, 2019

Study contacts

Kara A Witzke, PhD
principal investigator · Oregon State University - Cascades

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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