Postural BalanceNCT02771834
Evaluation of the Association Between Osteoporosis and Postural Balance in Postmenopausal Women
An observational study of Postural Balance, run by University of Sao Paulo.
Trial summary
The incidence of osteoporosis has been increasing, as have fractures resulting from falls. Read more about this study
- Who is it for?
- Ages 55 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postural Balance
- What is being tested?
- Biomechanical analysis, Kiphosis analysis and Vitamin D level
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Dec 2012
- Phase
- Observational
- 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 55 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Postmenopausal women
Who may be able to join
- absence of impairment of the vestibular, proprioceptive, auditory or neurological system, and/or any mental disturbances or disorders;
- no use of medications that might compromise postural balance;
- absence of lesions, surgery or disease that might have caused lower-limb joint limitations over the previous six months;
- absence of lower-limb dysmetria;
- presence of clinically normal gait, without claudication.
Who cannot join
- the presence of pain or inability to complete any of the tests
- along with occurrences of blood pressure increase before the strength evaluation.
About this study
The incidence of osteoporosis has been increasing, as have fractures resulting from falls.
Read the detailed description
The overall objective of this study is to evaluate bipodal postural balance in postmenopausal women with and without lumbar osteoporosis. The specific objective is to determine the relationship between the degree of thoracic kyphosis and dosing of 25 OH vitamin D with postural balance in postmenopausal women with lumbar osteoporosis.
One hundred and twenty-six postmenopausal women between 55-65 years of age were evaluated and separated into two groups according to the bone mineral density values of their lumbar spine: the osteoporosis group and the control group.
Functional mobility was evaluated through the Timed Up and Go Test. Postural balance was evaluated using a AccuSway® model portable force platform, in standard standing position, with eyes open and closed, for 60". Data were collected, stored, and processed by the Balance Clinic® program, configured to 100 Hz frequency, with a frequency cut-off filter at 10 Hz.
Muscle strength was evaluated via a Biodex® isokinetic dynamometer in the concentric/concentric knee extension mode at 60o/s.
Dosing of 25 OH vitamin D and thoracic spine x-rays to determine the degree of kyphosis measured by the Cobb angle were performed in the osteoporosis group.
- Conditions
- Postural Balance
- Being tested
- Biomechanical analysis, Kiphosis analysis, Vitamin D level
- Keywords
- Postural balance, Osteoporosis, Postmenopause, Vitamin D, Kyfhosis, Muscle strength
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomechanical analysisOther
Kiphosis analysisOther
Vitamin D levelOther
| Study group | Role | What they receive |
|---|---|---|
| Experimental | women with osteoporosis Receives: Other: Biomechanical analysis; Other: Kiphosis analysis; Other: Vitamin D level | |
| Control | women without osteoporosis Receives: Other: Biomechanical analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Physical Activity Questionnaire
Measured: 1 day
Secondary outcomes (1)
Functional mobility
Was evaluated through the Timed Up and Go Test
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startJul 2009
- Primary completionJul 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postural BalanceStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Guilherme Carlos Brech, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771834
- Sponsor's protocol ID
- 320/09
- Status last verified
- May 2016
- First submitted
- 10 May 2016
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Brech GC, Ciolac EG, Peterson MD, Greve JM. Serum 25-hydroxyvitamin D levels are associated with functional capacity but not with postural balance in osteoporotic postmenopausal women. Clinics (Sao Paulo). 2017 Jan 1;72(1):11-16. doi: 10.6061/clinics/2017(01)03.
PubMed 28226027
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Association Between Osteoporosis and Postural Balance in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT02771834
- Acronym / sponsor ID
- 320/09
- Conditions
- Postural Balance
- Keywords
- Postural balance, Osteoporosis, Postmenopause, Vitamin D, Kyfhosis, Muscle strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jul 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 May 2016 (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.
The incidence of osteoporosis has been increasing, as have fractures resulting from falls.
Detailed description
The overall objective of this study is to evaluate bipodal postural balance in postmenopausal women with and without lumbar osteoporosis. The specific objective is to determine the relationship between the degree of thoracic kyphosis and dosing of 25 OH vitamin D with postural balance in postmenopausal women with lumbar osteoporosis.
One hundred and twenty-six postmenopausal women between 55-65 years of age were evaluated and separated into two groups according to the bone mineral density values of their lumbar spine: the osteoporosis group and the control group.
Functional mobility was evaluated through the Timed Up and Go Test. Postural balance was evaluated using a AccuSway® model portable force platform, in standard standing position, with eyes open and closed, for 60". Data were collected, stored, and processed by the Balance Clinic® program, configured to 100 Hz frequency, with a frequency cut-off filter at 10 Hz.
Muscle strength was evaluated via a Biodex® isokinetic dynamometer in the concentric/concentric knee extension mode at 60o/s.
Dosing of 25 OH vitamin D and thoracic spine x-rays to determine the degree of kyphosis measured by the Cobb angle were performed in the osteoporosis group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Other: Biomechanical analysis, Other: Kiphosis analysis, Other: Vitamin D levelwomen with osteoporosis |
| Control | – | Other: Biomechanical analysiswomen without osteoporosis |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal women
Key inclusion criteria (5 listed)
- absence of impairment of the vestibular, proprioceptive, auditory or neurological system, and/or any mental disturbances or disorders;
- no use of medications that might compromise postural balance;
- absence of lesions, surgery or disease that might have caused lower-limb joint limitations over the previous six months;
- absence of lower-limb dysmetria;
- presence of clinically normal gait, without claudication.
Key exclusion criteria (2 listed)
- the presence of pain or inability to complete any of the tests
- along with occurrences of blood pressure increase before the strength evaluation.
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 |
|---|---|---|
| Biomechanical analysis | Other | Control, Experimental |
| Kiphosis analysis | Other | Experimental |
| Vitamin D level | Other | Experimental |
Primary outcome
International Physical Activity Questionnaire
Time frame: 1 day
1 secondary outcome
Functional mobility
Time frame: 1 day
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 13 May 2016.
- Derived from this study: PubMed 28226027Brech GC, Ciolac EG, Peterson MD, Greve JM. Serum 25-hydroxyvitamin D levels are associated with functional capacity but not with postural balance in osteoporotic postmenopausal women. Clinics (Sao Paulo). 2017 Jan 1;72(1):11-16. doi: 10.6061/clinics/2017(01)03.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Postural Balance, run by University of Sao Paulo.
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 5 inclusion and 2 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 13 May 2016. 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?
International Physical Activity Questionnaire (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02771834, which also lists 1 linked publication.
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 13 May 2016.