An interventional study of Jump in Osteoporosis, Osteopenia, sponsored by California State University, San Marcos. Completed. Open to female participants aged 18 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-26.
Sponsored by California State University, San Marcos · Not applicable, Interventional, and Prevention
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.
Over 1 million hip and spine fractures each year are associated with osteoporosis, a disease of low bone mass that contributes to increased morbidity, mortality and economic strain on our medical system. Effective low-cost prevention strategies such as bone-loading exercise, could lower the incidence of osteoporotic fractures without an increase in medical costs, and provide an alternative to drug therapy. Activity associated with high magnitude forces such as fast running and jumping, have been shown to increase hip bone mass by 1.2%-4% in premenopausal women which may translate into a 20-30% reduction in hip fracture risk. In addition, high impact exercise may also produce benefits that are maintained long-term. However, a specific exercise prescription for improving bone health has not been determined.
To date, no single study has examined the interactive effects of jump magnitude (height) and jump number (repetitions) on bone mineral density by systematically varying the height and number of jumps performed. In addition, no study has evaluated the effects of loading exercise on multiple measures of bone health, in order to quantify the effects of exercise on bone strength, apart from bone mineral density. Determining the optimal dose of jump exercise for improving bone strength will allow the investigators to determine a specific exercise prescription for bone health in premenopausal women and will be useful in future projects that intend to employ jump training to target bone health. The long-term objective of this line of research is to determine how impact loading improves bone quality to ultimately reduce fracture risk.
This study is a randomized, controlled, trial to compare the effects of a 9-month supervised exercise program using three levels of load magnitude (4", 8", 12" jump height) and three load repetitions (10, 50, 100 jumps per session), on three dimensions of bone health (bone density, remodeling and strength) in 300 premenopausal women aged 18-42y. Bone density is the most widely recognized dimension of bone health and clinically accepted index of fracture risk. Bone remodeling reflects the dynamic state of bone and can predict fracture risk independent of bone density. Bone strength, represented by Femur Strength Index, is a reflection of the geometry and structural competence of bone.
Low-cost osteoporosis prevention strategies including jumping exercises, could lower the incidence of osteoporotic fractures without an increase in medical costs, and provide an alternative to drug therapy. This project will allow the investigators to determine the minimum effective dose of jumping exercise required to benefit bone health in premenopausal women and will lead to future research on how exercise improves bone quality and reduces fracture risk.
1,601 studies on the registry are indexed under Osteoporosis; 209 are open to participants now.
This study's enrollment of 357 is above the median of 88 across 1,084 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →California State University, San Marcos is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
10-cm step, 10 reps
Other: Jump
10-cm step, 50 reps
Other: Jump
10-cm step, 100 reps
Other: Jump
20-cm step, 10 reps
Other: Jump
20-cm step, 50 reps
Other: Jump
20-cm step, 100 reps
Other: Jump
30-cm step, 10 reps
Other: Jump
30-cm step, 50 reps
Other: Jump
30-cm step, 100 reps
Other: Jump
Control
Drop jump from step
Bone mineral density
Bone mineral density using dual-energy X-ray absorptiometry (DXA)
Time frame: Change from baseline bone mineral density at 9 months
Bone remodeling
Bone formation and resorption markers in blood
Time frame: Change from baseline bone formation and resorption markers at 9 months
Bone strength
Femur strength Index (FSI) calculated from DXA scan
Time frame: Change from baseline femur strength index at 9 months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Sep 2008 to primary completion in Jun 2012, 44 months.
Of 219 non-industry interventional studies with no phase under Osteoporosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 49. This study's 44 months is above that.
Counting every sponsor, half of 238 studies reached it within 26 months; a quarter within 9 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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California State University, San Marcos