The Effect of Vitamin D and Exercise on Balance in Postmenopausal Women

Study Overview
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Brief Summary
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In recent years, skeletal and nonskeletal effects of vitamin D has been studied. One of the effects of it was balance and fall prevention. However, these studies were performed on older patients who had not vitamin D deficiency. This study aimed to evaluate the effect of vitamin D replacement therapy and exercise on balance in 50-70 years-old postmenopausal women.

Official Title
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The Effect of Vitamin D and Exercise on Balance in Postmenopausal Women

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: Vitamin D
* Other: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 50-70 years-old postmenopausal women Vitamin D level<10 ng/ml and Vitamin D level>30 ng/ml Independant in daily life Able to do exercise Able to read and write in Turkish Exclusion Criteria: Diabetes mellitus, Polyneuropathy, Spinal stenosis, History of fracture or lower extremity operation, Rheumatologic diseases, History of chemotherapy Cognitive impairment

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D<10 ng/ml; Vitamin D replacement<br>Vitamin D replacement (50.000 IU/per week, for 8 weeks) | Dietary Supplement: Vitamin D<br>* Vitamin D3 50.000 IU/per week, for 8 weeks<br>* Other names: exercise;|
| Experimental: Vitamin D<10 ng/ml; Vitamin D replacement and exercise<br>Vitamin D replacement (50.000 IU/per week, for 8 weeks) and Core and balance exercises for 8 weeks. | Dietary Supplement: Vitamin D<br>* Vitamin D3 50.000 IU/per week, for 8 weeks<br>* Other names: exercise;|
| Experimental: Vitamin D<10 ng/ml; exercise<br>Core and balance exercises for 8 weeks. | Other: Exercise<br>* Core stability, balance exercises<br>|
| Active Comparator: Vitamin D>30ng/ml; exercise<br>Core and balance exercises for 8 weeks. | Other: Exercise<br>* Core stability, balance exercises<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postural Stability Test (Biodex) Assessed at Baseline | overall stability index: quantifying the ability to maintain dynamic postural stability The patient's score on this test assesses deviations from center, thus lower index means less instability and better balance. Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System. 0 is the minimum score, but there is no defined maximum score | Baseline | 
| Postural Stability Test (Biodex) Assessed After Treatment (8 Weeks) | overall stability index: quantifying the ability to maintain dynamic postural stability. The patient's score on this test assesses deviations from center, thus a lower score is more desirable than a higher score. Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System 0 is the minimum score, but there is no defined maximum score | After treatment (8 weeks) | 
| Berg Balance Test Assessed at Baseline | 14-item scale designed to measure balance of the older adult in a clinical setting minimum: 0 maximum: 56 A score of 56 indicates functional balance. A score of < 45 indicates individuals may be at greater risk of falling. | Baseline | 
| Berg Balance Test Assessed After Treatment (8weeks) | 14-item scale designed to measure balance of the older adult in a clinical setting minimum: 0 maximum: 56 A score of 56 indicates functional balance. A score of < 45 indicates individuals may be at greater risk of falling. | After treatment (8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fall Risk Assesment Performed at Baseline | Biodex fall risk screening test: Patients were instructed to maintain the vertical projection with their center of gravity in the midpoint of the platform 0 is the best possible value, higher score reflects increased risk of falling. But there is no defined maximum score | Baseline | 
| Fall Risk Assesment Performed After Treatment (8 Weeks) | Biodex fall risk screening test: Patients were instructed to maintain the vertical projection with their center of gravity in the midpoint of the platform 0° is the best possible value, higher score reflects increased risk of falling. But there is no defined maximum score. | After treatment (8 weeks) | 
| Health Status Assessed at Baseline | Notthingham Health Profile: general patient reported outcome measure which measures subjective health status. 38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted valuesin a given subarea adds up to 100. Overall score is calculated by summing up 6 subdomian scores. Ovearall minimum: 0 maximum: 600 (6X100) Higher scores reflect worse health status | Baseline | 
| Health Status Assessed After Treatment (8 Weeks) | Notthingham Health Profile: general patient reported outcome measure which measures subjective health status. 38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted valuesin a given subarea adds up to 100. Overall score is calculated by summing up 6 subdomian scores. Ovearall minimum: 0 maximum: 600 (6X100) Higher scores reflect worse health status. | After treatment (8 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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balance, vitamin D, exercise, fall risk