Effects of Jumping on Growing Bones
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Exercise intervention
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis focused on measuring Osteoporosis, Bone fractures, Bone mass, Bone mineral density (BMD), Ossification, Biomechanics, Exercise, Diet, Spine, Middle childhood (6-11)
Eligibility Criteria
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
Sites / Locations
- Oregon State University
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000405
First Posted
November 3, 1999
Last Updated
June 7, 2016
Sponsor
Oregon State University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1. Study Identification
Unique Protocol Identification Number
NCT00000405
Brief Title
Effects of Jumping on Growing Bones
Official Title
The Effects of Jumping on Growing Bones
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
September 1998 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon State University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
4. Oversight
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Osteoporosis, Bone fractures, Bone mass, Bone mineral density (BMD), Ossification, Biomechanics, Exercise, Diet, Spine, Middle childhood (6-11)
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Exercise intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine M. Snow, PhD
Organizational Affiliation
Oregon State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon State University
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97331
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
1805545
Citation
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.
Results Reference
background
PubMed Identifier
10841187
Citation
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.
Results Reference
background
PubMed Identifier
10773099
Citation
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.
Results Reference
background
PubMed Identifier
10657819
Citation
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.
Results Reference
background
PubMed Identifier
11149479
Citation
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.
Results Reference
background
PubMed Identifier
12219055
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
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Effects of Jumping on Growing Bones
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