OsteoporosisAd/AbNCT01228877
The Effect of 16 Weeks of Hip Adduction and Abduction Resistance Exercise
A study testing exercise in people with Osteoporosis and Osteopenia, run by University of California, San Francisco at 1 site in United States.
Trial summary
Performing adduction and abduction resistance exercise will increase hip bone density and strength to a greater extent than doing squat and deadlift exercise. Aim #1: To determine if doing hip adduction and abduction resistance exercise training for 16 weeks improves spine bone mineral density and hip bone mineral… Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Osteopenia, Sarcopenia
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Sep 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women
- Age of 25 to 55 years old
Who cannot join
- Hypertension (High blood pressure)
- Diabetes or metabolic syndrome
- Hyperlipidemia (High cholesterol)
- Cardiovascular Disease
- Asthma or other pulmonary disease (i.e. COPD)
- not pregnant
- have no joint or mobility limitations
- do not exercise on a regular basis
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF-Department of radiology-China Basin
San Francisco, California, 94107
About this study
Official title: The Effect of 16 Weeks of Hip Adduction and Abduction Resistance Exercise Training on Strength and Density of the Proximal Femur
Performing adduction and abduction resistance exercise will increase hip bone density and strength to a greater extent than doing squat and deadlift exercise.
Aim #1: To determine if doing hip adduction and abduction resistance exercise training for 16 weeks improves spine bone mineral density and hip bone mineral density and strength as determined by finite element modeling.
Read more
Aim #2: To compare the effects of hip adduction and abduction exercise to squat and deadlift exercise with respect to potential changes in hip bone mineral density and strength.
Aim #3: To determine if the addition of adduction and abduction exercise to squat and deadlift exercise promotes an "additive" effect with respect to changes in spine bone mineral density and hip bone mineral density and bone strength.
Read the detailed description
The investigators will carry out a 16-week exercise training study (n=24) consisting of 3 groups (n=8 per group) of healthy, non-resistance trained adult men and women (age 25-55 years). Our aim is to determine if hip adduction and abduction resistance exercise is more effective than squat and deadlift exercise with respect to changes in the whole bone strength and density of the proximal femur and spine.
Group A will do only hip adduction and abduction exercises. Group B will do only squat and deadlift exercise Group C will do a combination of hip adduction and abduction and squat and deadlift exercise
Subjects will be imaged with quantitative computed tomography (QCT) of the proximal femur and spine, pre-training and post-training, to determine changes in spinal bone density and proximal femoral bone density and strength.
Serum assays of bone formation (osteocalcin) and bone resorption (serum CTX type I) will be performed four times during the study at 4 week intervals.
- Conditions
- Osteoporosis, Osteopenia, Sarcopenia
- Being tested
- exercise
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
Adduction, Abduction and Squat exercise three times a week for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Adduction, Abduction and Squat exercise three times a week for 16 weeks Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce risk of hip fracture
The investigators have prioritized the last year of NSBRI funding to test one the capabilities of our device, standing hip adduction/abduction exercise, to strengthen the proximal femoral bone. We believe that if we are able to detect increases in bone density and strength (assessed using quantitative computed tomography of the hip pre- and post-training) in healthy volunteers, this will be solid preliminary evidence to support modification of exercise protocols currently being used to reduce the rate of bone loss on the International Space Station.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2010 (estimated)
- Study startDec 2010
- Primary completionJun 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Space Biomedical Research Institute
- Responsible party
- Sponsor
- Investigators
- Thomas Lang, PhD, Principal investigator, UCSF-Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228877
- Sponsor's protocol ID
- Ad/Ab exercise
- Acronym
- Ad/Ab
- Status last verified
- Oct 2017
- First submitted
- 8 Oct 2010
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 16 Weeks of Hip Adduction and Abduction Resistance Exercise Training on Strength and Density of the Proximal Femur
- ClinicalTrials.gov ID
- NCT01228877
- Acronym / sponsor ID
- Ad/Ab / Ad/Ab exercise
- Conditions
- Osteoporosis, Osteopenia, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Space Biomedical Research Institute
- Study start
- Dec 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 27 Oct 2010 (estimated)
- 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.
Performing adduction and abduction resistance exercise will increase hip bone density and strength to a greater extent than doing squat and deadlift exercise.
Aim #1: To determine if doing hip adduction and abduction resistance exercise training for 16 weeks improves spine bone mineral density and hip bone mineral density and strength as determined by finite element modeling.
Aim #2: To compare the effects of hip adduction and abduction exercise to squat and deadlift exercise with respect to potential changes in hip bone mineral density and strength.
Aim #3: To determine if the addition of adduction and abduction exercise to squat and deadlift exercise promotes an "additive" effect with respect to changes in spine bone mineral density and hip bone mineral density and bone strength.
Detailed description
The investigators will carry out a 16-week exercise training study (n=24) consisting of 3 groups (n=8 per group) of healthy, non-resistance trained adult men and women (age 25-55 years). Our aim is to determine if hip adduction and abduction resistance exercise is more effective than squat and deadlift exercise with respect to changes in the whole bone strength and density of the proximal femur and spine.
Group A will do only hip adduction and abduction exercises. Group B will do only squat and deadlift exercise Group C will do a combination of hip adduction and abduction and squat and deadlift exercise
Subjects will be imaged with quantitative computed tomography (QCT) of the proximal femur and spine, pre-training and post-training, to determine changes in spinal bone density and proximal femoral bone density and strength.
Serum assays of bone formation (osteocalcin) and bone resorption (serum CTX type I) will be performed four times during the study at 4 week intervals.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: exerciseAdduction, Abduction and Squat exercise three times a week for 16 weeks |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy men and women
- Age of 25 to 55 years old
Key exclusion criteria (8 listed)
- Hypertension (High blood pressure)
- Diabetes or metabolic syndrome
- Hyperlipidemia (High cholesterol)
- Cardiovascular Disease
- Asthma or other pulmonary disease (i.e. COPD)
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 |
|---|---|---|
| exerciseAdduction, Abduction and Squat exercise three times a week for 16 weeks | Other | Exercise |
Primary outcome
Reduce risk of hip fracture
Time frame: 16 weeks
The investigators have prioritized the last year of NSBRI funding to test one the capabilities of our device, standing hip adduction/abduction exercise, to strengthen the proximal femoral bone. We believe that if we are able to detect increases in bone density and strength (assessed using quantitative computed tomography of the hip pre- and post-training) in healthy volunteers, this will be solid preliminary evidence to support modification of exercise protocols currently being used to reduce the rate of bone loss on the International Space Station.
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 27 Oct 2017.
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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.
Thomas Lang, PhD principal investigator
UCSF-Department of Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Osteoporosis and Osteopenia, run by University of California, San Francisco at 1 site in United States.
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 2 inclusion and 8 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 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Reduce risk of hip fracture (time frame: 16 weeks). 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 27 Oct 2017.