Effects of Vitamin D and Exercise in Preventing Falls of Elderly Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 409
- 试验地点
- 2
- 主要终点
- number of falls
研究概览
简要总结
The aim of the study is to investigate the effects of exercise and vitamin D supplementation on reducing falls and injuries in community-dwelling, independent-living women aged 70-79 years of age. The investigators will test the following hypothesis:
- Exercise including strength, balance and mobility training will improve muscle functioning and body balance, and thus reduce falls by 30% compared with non-exercisers.
- Vitamin D intake will improve muscle functioning and thus prevent falls by 30% compared with placebo.
- Together vitamin D and exercise have a stronger influence on fall prevention than either used alone.
- Training improves mobility functions and bone health.
- Supervised training twice a week with daily home training will improve physical functioning thus resulting in reduced fear of falling.
- Reduced fear of falling and improved physical functioning help older people to stay physically active, which further improve their quality of life.
详细描述
Falls account for over 80% of all injury-related admissions to hospital among older people. Although there is evidence that both exercise and vitamin D improve neuromuscular and cognitive function, and may thus reduce the risk of falls and fractures, these two factors have never been evaluated together in a clinical trial. This study is a randomized 24-month intervention in elderly women. The investigators hypothesize that exercise and vitamin D supplementation reduce falls and injuries including fractures in community-dwelling, independent-living women 70-79 years of age. The eligible participants will be randomly assigned into one of four groups:
- exercise with vitamin D
- exercise with placebo
- no exercise with vitamin D
- no exercise with placebo. The rational of this study is to provide important information on how to maintain and improve physical functioning and thus prevent falls and fractures of elderly people. In addition, if fear of falling can be declined with this program, it will further help elderly people to keep physically active and maintain their functional capacity and quality of life.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 70 Years 至 80 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age 70-80 years old
- •lives at home independently
- •has fallen at least once during the previous year
- •no contraindication to exercise
- •understands the procedures of the study
- •has been informed of X-ray radiation doses of the DXA and pQCT investigations
排除标准
- •moderate-to-vigorous exercise more than 2 hours per week
- •regular use of vitamin D, or calcium + vitamin D supplements
- •a recent fracture (during preceding 12 months)
- •contraindication or inability to participate in the exercise program
- •marked decline in the basic activities of daily living (ADL-test)
- •cognitive impairments (Mini Mental State Examination, MMSE-test < 18)
- •persons with chronic disease conditions, such as Parkinson's disease
结局指标
主要结局
number of falls
时间窗: 24 months
次要结局
- number of fallers(24 months)
- bone mass(24 months)
- fall-related injuries including bone fractures(24 months)
- physical functioning(24 months)
- fear of falling(24 months)
研究者
Kirsti Uusi-Rasi
Ph.D./ senior researcher
UKK Institute