Completed

Effects of Jumping on Growing Bones

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What is being tested

Exercise intervention

Procedure
Who is being recruted

Osteoporosis

From 5 to 10 Years
+5 Eligibility Criteria
How is the trial designed

Prevention Study

Phase 2
Interventional
Study Start: September 1998

Summary

Principal SponsorOregon State University
Last updated: June 9, 2016
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 1998Actual date on which the first participant was enrolled.

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. 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.

Official TitleThe Effects of Jumping on Growing Bones 
Principal SponsorOregon State University
Last updated: June 9, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
200 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive different combinations of treatments to see how they work together. This approach helps researchers determine whether a combination of treatments is more effective than a single treatment alone.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 5 to 10 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Osteoporosis
Criteria
2 inclusion criteria required to participate
Apparently healthy boys and girls

BMI < 30kg/m2

3 exclusion criteria prevent from participating
BMI < 30kg/m2

Orthopedic problems that would limit physical participation

Metabolic diseases that would influence bone metabolism


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Oregon State UniversityCorvallis, United StatesSee the location

CompletedOne Study Center