NCT00000405

Brief Summary

In this study we will investigate the effects of a high-impact exercise program involving jumping on bone mass (the amount of bone) of the hip and backbone in the growing skeleton. We will also look at the effects of gradually stopping the jumping program on bone mass in the growing skeleton. A high-impact exercise program may build more bone during childhood, while the skeleton is still growing. This may help prevent broken bones due to loss of bone mass later in life. We will recruit 200 children aged 5-10 to participate in the study. For 6 months we will train the children in either a jumping or stretching program. We will then gradually reduce the amount of exercise over 6 months. We will measure bone mass in the hip and backbone at the start of the study, after jumping, and 6 months after the jumping program is stopped. We will compare the results in the jumping and stretching groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 1998

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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 1, 1998

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

June 9, 2016

Status Verified

June 1, 2016

Enrollment Period

9.8 years

First QC Date

November 3, 1999

Last Update Submit

June 7, 2016

Conditions

Osteoporosis

Keywords

OsteoporosisBone fracturesBone massBone mineral density (BMD)OssificationBiomechanicsExerciseDietSpineMiddle childhood (6-11)

Interventions

Exercise interventionPROCEDURE

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Apparently healthy boys and girls
  • BMI \< 30kg/m2

You may not qualify if:

  • BMI \< 30kg/m2
  • Orthopedic problems that would limit physical participation
  • Metabolic diseases that would influence bone metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon State University

Corvallis, Oregon, 97331, United States

Location

Related Publications (7)

  • Slemenda CW, Miller JZ, Hui SL, Reister TK, Johnston CC Jr. Role of physical activity in the development of skeletal mass in children. J Bone Miner Res. 1991 Nov;6(11):1227-33. doi: 10.1002/jbmr.5650061113.

    PMID: 1805545BACKGROUND

  • McKay HA, Petit MA, Bailey DA, Wallace WM, Schutz RW, Khan KM. Analysis of proximal femur DXA scans in growing children: comparisons of different protocols for cross-sectional 8-month and 7-year longitudinal data. J Bone Miner Res. 2000 Jun;15(6):1181-8. doi: 10.1359/jbmr.2000.15.6.1181.

    PMID: 10841187BACKGROUND

  • McKay HA, Petit MA, Khan KM, Schutz RW. Lifestyle determinants of bone mineral: a comparison between prepubertal Asian- and Caucasian-Canadian boys and girls. Calcif Tissue Int. 2000 May;66(5):320-4. doi: 10.1007/s002230010067.

    PMID: 10773099BACKGROUND

  • McKay HA, Petit MA, Schutz RW, Prior JC, Barr SI, Khan KM. Augmented trochanteric bone mineral density after modified physical education classes: a randomized school-based exercise intervention study in prepubescent and early pubescent children. J Pediatr. 2000 Feb;136(2):156-62. doi: 10.1016/s0022-3476(00)70095-3.

    PMID: 10657819BACKGROUND

  • Fuchs RK, Bauer JJ, Snow CM. Jumping improves hip and lumbar spine bone mass in prepubescent children: a randomized controlled trial. J Bone Miner Res. 2001 Jan;16(1):148-56. doi: 10.1359/jbmr.2001.16.1.148.

    PMID: 11149479BACKGROUND

  • Fuchs RK, Snow CM. Gains in hip bone mass from high-impact training are maintained: a randomized controlled trial in children. J Pediatr. 2002 Sep;141(3):357-62. doi: 10.1067/mpd.2002.127275.

    PMID: 12219055BACKGROUND

  • Bauer J, Smith G, Snow CM. Quantifying force magnitude and loading rate from drop landings that induce osteogenesis. J Appl Biomech, 17(2):142-152, 2001

    BACKGROUND

MeSH Terms

Conditions

OsteoporosisFractures, BoneMotor Activity

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesWounds and InjuriesBehavior

Study Officials

  • Christine M. Snow, PhD

    Oregon State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emeritus

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

September 1, 1998

Primary Completion

June 1, 2008

Study Completion

November 1, 2008

Last Updated

June 9, 2016

Record last verified: 2016-06

Locations

US(1)