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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
California State University, San Marcos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis, Osteopenia focused on measuring jumping, bone health

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    January 21, 2018
    Last Updated
    July 24, 2019
    Sponsor
    California State University, San Marcos
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    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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