Back to resultsThe Effect of Vitamin D and Exercise on Balance in Postmenopausal Women
Primary Purpose
Vitamin D Deficiency
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Vitamin D
Exercise
Sponsored by
About this trial
This is an interventional prevention trial for Vitamin D Deficiency focused on measuring balance, vitamin D, exercise, fall risk
Eligibility Criteria
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
Sites / Locations
- Sultan Abdulhamid Han Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Vitamin D<10 ng/ml; Vitamin D replacement
Vitamin D<10 ng/ml; Vitamin D replacement and exercise
Vitamin D<10 ng/ml; exercise
Vitamin D>30ng/ml; exercise
Arm Description
Vitamin D replacement (50.000 IU/per week, for 8 weeks)
Vitamin D replacement (50.000 IU/per week, for 8 weeks) and Core and balance exercises for 8 weeks.
Core and balance exercises for 8 weeks.
Core and balance exercises for 8 weeks.
Outcomes
Primary Outcome Measures
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
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
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.
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.
Secondary Outcome Measures
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
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.
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
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.
Full Information
NCT ID
NCT03608488
First Posted
July 4, 2018
Last Updated
June 22, 2020
Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
1. Study Identification
Unique Protocol Identification Number
NCT03608488
Brief Title
The Effect of Vitamin D and Exercise on Balance in Postmenopausal Women
Official Title
The Effect of Vitamin D and Exercise on Balance in Postmenopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 6, 2018 (Actual)
Primary Completion Date
July 12, 2019 (Actual)
Study Completion Date
July 12, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
balance, vitamin D, exercise, fall risk
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D<10 ng/ml; Vitamin D replacement
Arm Type
Experimental
Arm Description
Vitamin D replacement (50.000 IU/per week, for 8 weeks)
Arm Title
Vitamin D<10 ng/ml; Vitamin D replacement and exercise
Arm Type
Experimental
Arm Description
Vitamin D replacement (50.000 IU/per week, for 8 weeks) and Core and balance exercises for 8 weeks.
Arm Title
Vitamin D<10 ng/ml; exercise
Arm Type
Experimental
Arm Description
Core and balance exercises for 8 weeks.
Arm Title
Vitamin D>30ng/ml; exercise
Arm Type
Active Comparator
Arm Description
Core and balance exercises for 8 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
exercise
Intervention Description
Vitamin D3 50.000 IU/per week, for 8 weeks
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Core stability, balance exercises
Primary Outcome Measure Information:
Title
Postural Stability Test (Biodex) Assessed at Baseline
Description
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
Time Frame
Baseline
Title
Postural Stability Test (Biodex) Assessed After Treatment (8 Weeks)
Description
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
Time Frame
After treatment (8 weeks)
Title
Berg Balance Test Assessed at Baseline
Description
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.
Time Frame
Baseline
Title
Berg Balance Test Assessed After Treatment (8weeks)
Description
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.
Time Frame
After treatment (8 weeks)
Secondary Outcome Measure Information:
Title
Fall Risk Assesment Performed at Baseline
Description
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
Time Frame
Baseline
Title
Fall Risk Assesment Performed After Treatment (8 Weeks)
Description
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.
Time Frame
After treatment (8 weeks)
Title
Health Status Assessed at Baseline
Description
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
Time Frame
Baseline
Title
Health Status Assessed After Treatment (8 Weeks)
Description
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.
Time Frame
After treatment (8 weeks)
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tugba Ozsoy-Unubol, MD
Organizational Affiliation
Sultan Abdulhamid Han Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sultan Abdulhamid Han Training and Research Hospital
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Vitamin D and Exercise on Balance in Postmenopausal Women
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