NCT00249704终止1 期
Evaluation of the Effect of a 4-Month Intervention of Exercise and/or Vitamin D on Mobility Function and Strength in Frail Elderly Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Characterization of effect of 4-month exercise and/or Vitamin D intervention on mobility function and strength in frail elderly subjects.
研究概览
简要总结
The study will explore multiple mobility function tests as well as functional and neuropsychological tests in elderly subjects at risk for falls and disability, before and after 4-month exercise and/or Vitamin D intervention.
详细描述
The study was terminated on 10Jan2008. This was a strategic decision not related to safety, efficacy, or feasibility of trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elderly subjects with moderate frailty residing in assisted living facilities.
排除标准
- •Presence of progressive, unstable chronic disease; hyperparathyroidism, hypercalcemia.
研究组 & 干预措施
C
Experimental
干预措施: Vitamin D Placebo + Exercise (Procedure)
B
Experimental
干预措施: Vitamin D + Sham Exercise (Drug)
A
Experimental
干预措施: Vitamin D + Exercise (Drug)
D
Placebo Comparator
干预措施: Vitamin D Placebo + Sham Exercise (Procedure)
结局指标
主要结局
Characterization of effect of 4-month exercise and/or Vitamin D intervention on mobility function and strength in frail elderly subjects.
时间窗: Throughout trial
次要结局
- Evaluation of utility and variability of mobility function tests and biomarkers, as well as explore the predictors for the exercise and/or Vitamin D intervention response in frail elderly subjects.(throughout trial)
研究者
研究点 (1)
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