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

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03608488
• Other study ID #: Tugbaozsoy
• Status: Completed
• Phase: N/A
• Start date: August 6, 2018
• Est. completion date: July 12, 2019

Study information

• Verified date: June 2020
• Source: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 12, 2019
• Est. primary completion date: July 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D
Vitamin D3 50.000 IU/per week, for 8 weeks

Other:
• Exercise
Core stability, balance exercises

Locations

Country	Name	City	State
Turkey	Sultan Abdulhamid Han Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Baseline
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	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.	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.	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	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.	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	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.	After treatment (8 weeks)