Skip to main content
OpenTrials
Completed

NCT Number: NCT03608488

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vitamin D Deficiency Avitaminosis Behavior Deficiency Diseases Malnutrition Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases

Age range

50 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sultan Abdulhamid Han Training and Research Hospital

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Dietary Supplement

Vitamin D3 50.000 IU/per week, for 8 weeks

Other names: exercise

Exercise

Other

Core stability, balance exercises

Primary outcomes

  1. Postural Stability Test (Biodex) Assessed at Baseline

    Time frame: 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

  2. Postural Stability Test (Biodex) Assessed After Treatment (8 Weeks)

    Time frame: 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

  3. Berg Balance Test Assessed at Baseline

    Time frame: 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.

  4. Berg Balance Test Assessed After Treatment (8weeks)

    Time frame: 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.

Secondary outcomes

  1. Fall Risk Assesment Performed at Baseline

    Time frame: 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

  2. Fall Risk Assesment Performed After Treatment (8 Weeks)

    Time frame: 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.

  3. Health Status Assessed at Baseline

    Time frame: 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

  4. Health Status Assessed After Treatment (8 Weeks)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 1, 2018
Registry last updated
Jul 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.