Osteoporosis, OsteopeniaNCT03413540
Effects of Jumping on Bone Health in Young Women
A study testing Jump in people with Osteoporosis, Osteopenia, run by California State University, San Marcos.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Osteopenia
- What is being tested?
- Jump
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 357 participants
- Where
- No sites listed yet
- Study dates
- 28 Sep 2008to 13 Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Premenopausal with a history of regular menses (10-12 cycles/year)
Who cannot join
- Current smoking
- Obesity (BMI > 30 kg/m2) or underweight (BMI < 18 kg/m2)
- Use of medications known to affect bone metabolism including thyroid hormone, thiazide diuretics, aromatase inhibitors, hormone replacement therapy, selective estrogen receptor modulators (SERMS) and bisphosphonates within the previous 6 months. (Note: Women currently using hormonal birth control (e.g. estrogen, progesterone, depot medroxyprogesterone acetate) for at least the previous 12 months will not be excluded from participation, but will be asked to continue with their current method throughout the study period).
- Chronic disorders that affect bone metabolism and/or the ability to participate in exercise training such as diabetes, hyperparathyroidism, uncontrolled hypothyroidism, balance difficulties, use of narcotic medication.
- Regular participation in exercise associated with a large volume of jumping (i.e., volleyball, basketball, high-impact aerobics, plyometrics, gymnastics, etc) within the past year.
About this study
Official title: Dose-Dependent Effects of Jumping on Bone Health in Premenopausal Women
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.
Read the detailed description
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.
- Conditions
- Osteoporosis, Osteopenia
- Being tested
- Jump
- Keywords
- jumping, bone health
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JumpOther
Drop jump from step
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 10-cm step, 10 reps Receives: Other: Jump |
| Group 2 | Experimental | 10-cm step, 50 reps Receives: Other: Jump |
| Group 3 | Experimental | 10-cm step, 100 reps Receives: Other: Jump |
| Group 4 | Experimental | 20-cm step, 10 reps Receives: Other: Jump |
| Group 5 | Experimental | 20-cm step, 50 reps Receives: Other: Jump |
| Group 6 | Experimental | 20-cm step, 100 reps Receives: Other: Jump |
| Group 7 | Experimental | 30-cm step, 10 reps Receives: Other: Jump |
| Group 8 | Experimental | 30-cm step, 50 reps Receives: Other: Jump |
| Group 9 | Experimental | 30-cm step, 100 reps Receives: Other: Jump |
| Group 10 | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
Bone mineral density using dual-energy X-ray absorptiometry (DXA)
Measured: Change from baseline bone mineral density at 9 months
Secondary outcomes (2)
Bone remodeling
Bone formation and resorption markers in blood
Measured: Change from baseline bone formation and resorption markers at 9 months
Bone strength
Femur strength Index (FSI) calculated from DXA scan
Measured: Change from baseline femur strength index at 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start28 Sep 2008
- Primary completion13 Jun 2012
- Study completion13 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, OsteopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 357 participants (actual)
Sponsor and investigators
- Lead sponsor
- California State University, San Marcos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kara Witzke, California State University, San Marcos
- Investigators
- Kara A Witzke, PhD, Principal investigator, Oregon State University - Cascades
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413540
- Sponsor's protocol ID
- 1SC3GM084705
- Status last verified
- Jul 2019
- First submitted
- 21 Jan 2018
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Dependent Effects of Jumping on Bone Health in Premenopausal Women
- ClinicalTrials.gov ID
- NCT03413540
- Acronym / sponsor ID
- 1SC3GM084705
- Conditions
- Osteoporosis, Osteopenia
- Keywords
- jumping, bone health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- California State University, San MarcosUniversity, hospital or other
- Study start
- 28 Sep 2008 (actual)
- Primary completion
- 13 Jun 2012 (actual)
- Study completion
- 13 Jun 2012 (actual)
- First posted
- 29 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Jump10-cm step, 10 reps |
| Group 2 | Experimental | Other: Jump10-cm step, 50 reps |
| Group 3 | Experimental | Other: Jump10-cm step, 100 reps |
| Group 4 | Experimental | Other: Jump20-cm step, 10 reps |
| Group 5 | Experimental | Other: Jump20-cm step, 50 reps |
| Group 6 | Experimental | Other: Jump20-cm step, 100 reps |
| Group 7 | Experimental | Other: Jump30-cm step, 10 reps |
| Group 8 | Experimental | Other: Jump30-cm step, 50 reps |
| Group 9 | Experimental | Other: Jump30-cm step, 100 reps |
| Group 10 | No intervention | –Control |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Premenopausal with a history of regular menses (10-12 cycles/year)
Key exclusion criteria (5 listed)
- Current smoking
- Obesity (BMI > 30 kg/m2) or underweight (BMI < 18 kg/m2)
- Use of medications known to affect bone metabolism including thyroid hormone, thiazide diuretics, aromatase inhibitors, hormone replacement therapy, selective estrogen receptor modulators (SERMS) and bisphosphonates within the previous 6 months. (Note: Women currently using hormonal birth control (e.g. estrogen, progesterone, depot medroxyprogesterone acetate) for at least the previous 12 months will not be excluded from participation, but will be asked to continue with their current method throughout the study period).
- Chronic disorders that affect bone metabolism and/or the ability to participate in exercise training such as diabetes, hyperparathyroidism, uncontrolled hypothyroidism, balance difficulties, use of narcotic medication.
- Regular participation in exercise associated with a large volume of jumping (i.e., volleyball, basketball, high-impact aerobics, plyometrics, gymnastics, etc) within the past year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JumpDrop jump from step | Other | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6, Group 7, Group 8, Group 9 |
Primary outcome
Bone mineral density
Time frame: Change from baseline bone mineral density at 9 months
Bone mineral density using dual-energy X-ray absorptiometry (DXA)
2 secondary outcomes
Bone remodeling
Time frame: Change from baseline bone formation and resorption markers at 9 months
Bone strength
Time frame: Change from baseline femur strength index at 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kara A Witzke, PhD principal investigator
Oregon State University - Cascades
Questions about this trial
What is this clinical trial studying?
A study testing Jump in people with Osteoporosis, Osteopenia, run by California State University, San Marcos.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density (time frame: Change from baseline bone mineral density at 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.