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

Not Applicable

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Dietary Supplement: Vitamin D; Other: Exercise

• Registration Number: NCT03608488
• Lead Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-04
• Study First Submitted QC: 2018-07-23
• Study First Posted: 2018-08-01
• Study Start: 2018-08-06
• Primary Completion: 2019-07-12
• Study Completion: 2019-07-12
• Results First Submitted: 2019-09-22
• Results First Submitted QC: 2020-02-14
• Results First Posted: 2020-02-27
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-22
• Last Update Posted: 2020-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D<10 ng/ml; Vitamin D replacement	Vitamin D	Vitamin D replacement (50.000 IU/per week, for 8 weeks)
Vitamin D<10 ng/ml; exercise	Exercise	Core and balance exercises for 8 weeks.
Vitamin D>30ng/ml; exercise	Exercise	Core and balance exercises for 8 weeks.
Vitamin D<10 ng/ml; Vitamin D replacement and exercise	Vitamin D	Vitamin D replacement (50.000 IU/per week, for 8 weeks) and Core and balance exercises for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Berg Balance Test Assessed After Treatment (8weeks)	After treatment (8 weeks)	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.
Postural Stability Test (Biodex) Assessed at Baseline	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
Berg Balance Test Assessed at Baseline	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.
Postural Stability Test (Biodex) Assessed After Treatment (8 Weeks)	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

Secondary Outcome Measures

Name	Time	Method
Health Status Assessed at Baseline	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)	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.
Fall Risk Assesment Performed at Baseline	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)	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.

Trial Locations

Locations (1)

Sultan Abdulhamid Han Training and Research Hospital; 🇹🇷 Istanbul, Turkey