Effects of Jumping on Growing Bones

NCT ID: NCT00000405

Last Updated: 2016-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-09-30

Study Completion Date

2008-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Osteoporotic fractures are increasing at an alarming rate in this country and result in over 13 billion dollars in health costs annually. Peak bone mass, that is, an individual's maximum bone mass at the completion of skeletal acquisition, is an important determinant of fracture risk. Thus, maximizing peak bone mass may provide an effective strategy for preventing osteopenia and osteoporosis.

Various investigators have postulated that increasing bone mass by 3-5 percent would reduce fracture risk by 20-30 percent. Our data in collegiate female gymnasts demonstrate hip and spine bone mineral density values of up to 40 percent above values in normal age-matched controls and elite runners, despite menstrual irregularities. Further, we have observed the dynamic response of bone to high-impact forces in gymnasts over the training season as bone increases of 2-5 percent.

This is a randomized, controlled exercise intervention designed to evaluate the effect of high-impact loading as a means to increase bone mass during development. It will determine bone mass accrual and bone geometry at the lumbar spine and proximal femur in prepubescent girls and boys. Further, this study will evaluate the bone response from withdrawal of the stimulus over 6 months.

We will recruit 200 pre-pubescent children during two separate years and randomly assign them to a jumping or a stretching group. The jumping group will perform double leg jumps and the stretching group will act as a control. Outcome variables include bone mineral density (BMD) at the spine and hip, estimated bone volumetric density at the spine, and cross-sectional geometry of the femoral neck and diaphysis.

Implementing a specific bone-loading program during childhood will potentially allow the bone to increase both its mass and mineralization at an earlier age and therefore provide a larger foundation of mineralization for further growth throughout adolescence until skeletal maturity is reached. We expect our findings to provide a basis for the design of strategies to build bone during growth and thereby reduce osteoporotic fractures.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoporosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exercise intervention

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* BMI \< 30kg/m2
* Orthopedic problems that would limit physical participation
* Metabolic diseases that would influence bone metabolism
Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role collaborator

Oregon State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Christine M. Snow

Emeritus

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christine M. Snow, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon State University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Oregon State University

Corvallis, Oregon, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 1805545 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10841187 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10773099 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10657819 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11149479 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12219055 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01AR045655

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIAMS-009

Identifier Type: -

Identifier Source: secondary_id

R01AR045655

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Calcium and Bone Mass in Young Females
NCT00000402 COMPLETED PHASE2