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临床试验/NCT03608488
NCT03608488已完成不适用

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

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2018年8月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
110
试验地点
1
主要终点
Berg Balance Test Assessed After Treatment (8weeks)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Berg Balance Test Assessed After Treatment (8weeks)

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: 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

次要结局

  • Health Status Assessed at Baseline(Baseline)
  • Health Status Assessed After Treatment (8 Weeks)(After treatment (8 weeks))
  • Fall Risk Assesment Performed at Baseline(Baseline)
  • Fall Risk Assesment Performed After Treatment (8 Weeks)(After treatment (8 weeks))

研究者

发起方
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
申办方类型
Other
责任方
Sponsor

研究点 (1)

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