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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D<10 ng/ml; Vitamin D replacement | Experimental | Vitamin D replacement (50.000 IU/per week, for 8 weeks) |
|
| Vitamin D<10 ng/ml; Vitamin D replacement and exercise | Experimental | Vitamin D replacement (50.000 IU/per week, for 8 weeks) and Core and balance exercises for 8 weeks. |
|
| Vitamin D<10 ng/ml; exercise | Experimental | Core and balance exercises for 8 weeks. |
|
| Vitamin D>30ng/ml; exercise | Active Comparator | Core and balance exercises for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Dietary Supplement | Vitamin D3 50.000 IU/per week, for 8 weeks |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tugba Ozsoy-Unubol, MD | Sultan Abdulhamid Han Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sultan Abdulhamid Han Training and Research Hospital | Istanbul | Turkey (Türkiye) |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D<10 ng/ml; Vitamin D Replacement | Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks |
| FG001 | Vitamin D<10 ng/ml; Exercise | Exercise: Core stability, balance exercises |
| FG002 | Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise | Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks and Exercise: Core stability, balance exercises |
| FG003 | Vitamin D>30ng/ml; Exercise | Exercise: Core stability, balance exercises |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D<10 ng/ml; Vitamin D Replacement | Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks |
| BG001 | Vitamin D<10 ng/ml; Exercise | Exercise: Core stability, balance exercises |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | score | Baseline |
|
Adverse Events were not monitored/assessed
Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamin D<10 ng/ml; Vitamin D Replacement | Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tugba OZsoy-Unubol | SultanAbdulhamid | +905074583382 | tugbaozsoyy@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2019 | Jan 18, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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|
| Exercise | Other | Core stability, balance exercises |
|
| 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) |
| BG002 | Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise | Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks and Exercise: Core stability, balance exercises |
| BG003 | Vitamin D>30ng/ml; Exercise | Exercise: Core stability, balance exercises |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Exercise: Core stability, balance exercises
| OG002 | Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise | Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks and Exercise: Core stability, balance exercises |
| OG003 | Vitamin D>30ng/ml; Exercise | Exercise: Core stability, balance exercises |
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | score | After treatment (8 weeks) |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | After treatment (8 weeks) |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | score | Baseline |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score | After treatment (8 weeks) |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | After treatment (8 weeks) |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Vitamin D<10 ng/ml; Exercise | Exercise: Core stability, balance exercises | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise | Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks and Exercise: Core stability, balance exercises | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Vitamin D>30ng/ml; Exercise | Exercise: Core stability, balance exercises | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001519 | Behavior |
| D009043 |
| Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |