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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: Vitamin D; Other: Exercise

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Sultan Abdülhamid Han Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Vitamin D<10 ng/ml; Vitamin D replacement; Vitamin D replacement (50.000 IU/per week, for 8 weeks)	Dietary supplement: Vitamin D; Vitamin D3 50.000 IU/per week, for 8 weeks; Other Names: exercise
EXPERIMENTAL: Vitamin D<10 ng/ml; Vitamin D replacement and exercise; Vitamin D replacement (50.000 IU/per week, for 8 weeks) and Core and balance exercises for 8 weeks.	Dietary supplement: Vitamin D; Vitamin D3 50.000 IU/per week, for 8 weeks; Other Names: exercise
EXPERIMENTAL: Vitamin D<10 ng/ml; exercise; Core and balance exercises for 8 weeks.	Other: Exercise; Core stability, balance exercises
ACTIVE_COMPARATOR: Vitamin D>30ng/ml; exercise; Core and balance exercises for 8 weeks.	Other: Exercise; Core stability, balance exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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
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)

Collaborators and Investigators

• Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Investigators: Principal Investigator: Tugba Ozsoy-Unubol, MD, Sultan Abdülhamid Han Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 6, 2018
• Primary Completion (ACTUAL): July 12, 2019
• Study Completion (ACTUAL): July 12, 2019

Study Registration Dates

• First Submitted: July 4, 2018
• First Submitted That Met QC Criteria: July 23, 2018
• First Posted (ACTUAL): August 1, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 1, 2020
• Last Update Submitted That Met QC Criteria: June 22, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: exercise; vitamin D; balance; fall risk
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: Tugbaozsoy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No