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

NCT03608488 | Completed Results

• 1 other identifier: Tugbaozsoy
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Keywords

balance; vitamin D; exercise; fall risk

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Fall Risk Assesment Performed at Baseline

  Baseline

• Fall Risk Assesment Performed After Treatment (8 Weeks)

  After treatment (8 weeks)

• Health Status Assessed at Baseline

  Baseline

• Health Status Assessed After Treatment (8 Weeks)

  After treatment (8 weeks)

Study Arms (4)

Vitamin D<10 ng/ml; Vitamin D replacement

EXPERIMENTAL

Vitamin D replacement (50.000 IU/per week, for 8 weeks)

Dietary Supplement: Vitamin D

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.

Dietary Supplement: Vitamin D

Vitamin D<10 ng/ml; exercise

EXPERIMENTAL

Core and balance exercises for 8 weeks.

Other: Exercise

Vitamin D>30ng/ml; exercise

ACTIVE COMPARATOR

Core and balance exercises for 8 weeks.

Other: Exercise

Interventions

Vitamin D DIETARY_SUPPLEMENT

Vitamin D3 50.000 IU/per week, for 8 weeks

Also known as: exercise

Vitamin D<10 ng/ml; Vitamin D replacement; Vitamin D<10 ng/ml; Vitamin D replacement and exercise

Exercise OTHER

Core stability, balance exercises

Vitamin D<10 ng/ml; exercise; Vitamin D>30ng/ml; exercise

Eligibility Criteria

• Age: 50 Years - 70 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Diabetes mellitus,
• Polyneuropathy,
• Spinal stenosis,
• History of fracture or lower extremity operation,
• Rheumatologic diseases,
• History of chemotherapy
• Cognitive impairment

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Study Sites (1)

Sultan Abdulhamid Han Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Motor Activity

Interventions

Vitamin D; Exercise

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Tugba OZsoy-Unubol
• Organization: SultanAbdulhamid

tugbaozsoyy@gmail.com

+905074583382

Study Officials

• Tugba Ozsoy-Unubol, MD

  Sultan Abdulhamid Han Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: August 1, 2018
• Study Start: August 6, 2018
• Primary Completion: July 12, 2019
• Study Completion: July 12, 2019
• Last Updated: July 1, 2020
• Results First Posted: February 27, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)