NCT03413540

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
357

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 28, 2008

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2012

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
Last Updated

July 26, 2019

Status Verified

July 1, 2019

Enrollment Period

3.7 years

First QC Date

January 21, 2018

Last Update Submit

July 24, 2019

Conditions

Osteoporosis, Osteopenia

Keywords

jumpingbone health

Outcome Measures

Primary Outcomes (1)

  • Bone mineral density

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

    Change from baseline bone mineral density at 9 months

Secondary Outcomes (2)

  • Bone remodeling

    Change from baseline bone formation and resorption markers at 9 months

  • Bone strength

    Change from baseline femur strength index at 9 months

Study Arms (10)

Group 1

EXPERIMENTAL

10-cm step, 10 reps

Other: Jump

Group 2

EXPERIMENTAL

10-cm step, 50 reps

Other: Jump

Group 3

EXPERIMENTAL

10-cm step, 100 reps

Other: Jump

Group 4

EXPERIMENTAL

20-cm step, 10 reps

Other: Jump

Group 5

EXPERIMENTAL

20-cm step, 50 reps

Other: Jump

Group 6

EXPERIMENTAL

20-cm step, 100 reps

Other: Jump

Group 7

EXPERIMENTAL

30-cm step, 10 reps

Other: Jump

Group 8

EXPERIMENTAL

30-cm step, 50 reps

Other: Jump

Group 9

EXPERIMENTAL

30-cm step, 100 reps

Other: Jump

Group 10

NO INTERVENTION

Control

Interventions

JumpOTHER

Drop jump from step

Group 1Group 2Group 3Group 4Group 5Group 6Group 7Group 8Group 9

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPre-menopausal women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

OsteoporosisBone Diseases, Metabolic

Interventions

acj6 protein, Drosophila

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Kara A Witzke, PhD

    Oregon State University - Cascades

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Kinesiology

Study Record Dates

First Submitted

January 21, 2018

First Posted

January 29, 2018

Study Start

September 28, 2008

Primary Completion

June 13, 2012

Study Completion

June 13, 2012

Last Updated

July 26, 2019

Record last verified: 2019-07