Clinical trial NCT02771834: Evaluation of the Association Between Osteoporosis and Postural Balance in Postmenopausal Women
Official title: Evaluation of the Association Between Osteoporosis and Postural Balance in Postmenopausal Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postural Balance
Keywords: Postural balance
Osteoporosis
Postmenopause
Vitamin D
Kyfhosis
Muscle strength
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2016-05-13
Enrollment: 126
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Postmenopausal women

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: International Physical Activity Questionnaire
timeFrame: 1 day
Secondary outcomes:
measure: Functional mobility
timeFrame: 1 day
Other outcomes:
measure: Postural balance
timeFrame: 1 day
measure: Muscle strength
timeFrame: 1 day
measure: Vitamin D level
timeFrame: 1 day
measure: Degree of kyphosis
timeFrame: 1 day
Locations:
Study officials:
References:
citation: 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.