NCT Number: NCT02771834
Evaluation of the Association Between Osteoporosis and Postural Balance in Postmenopausal Women
The incidence of osteoporosis has been increasing, as have fractures resulting from falls.
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Notify MeKey information
Conditions
Age range
55 year–65 year
Sex eligibility
Female
Study type
Observational
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- the presence of pain or inability to complete any of the tests
- along with occurrences of blood pressure increase before the strength evaluation.
Treatment and study plan
Kiphosis analysis
OtherVitamin D level
OtherPrimary outcomes
-
International Physical Activity Questionnaire
Time frame: 1 day
Secondary outcomes
-
Functional mobility
Time frame: 1 day
Was evaluated through the Timed Up and Go Test
Other outcomes
-
Postural balance
Time frame: 1 day
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
Time frame: 1 day
Was evaluated via a Biodex® isokinetic dynamometer in the concentric/concentric knee extension mode at 60o/s.
-
Vitamin D level
Time frame: 1 day
Dosing of 25 OH vitamin D in a blood test
-
Degree of kyphosis
Time frame: 1 day
Thoracic spine x-rays to determine the degree of kyphosis measured by the Cobb angle were performed in the osteoporosis group
Sponsors and collaborators
Lead sponsor
University of Sao Paulo
Other
Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
Registry information
Important dates
- Study start
- 2009
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- May 13, 2016
- Registry last updated
- May 13, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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