Effectiveness of a Multifactorial Falls Prevention Program in Community-dwelling Older People When Compared to Usual Care: A Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 612
- 试验地点
- 1
- 主要终点
- rate of falls
研究概览
简要总结
This study is a clinical trial designed to evaluate the effectiveness of a multifactorial falls prevention program in reducing the rate of falls.
A multifactorial falls prevention program consisting of an individualized medical management of the modifiable risk factors, a progressive on-site body balance exercise plus a home-based exercise program, an educational/behavioral intervention and a fall prevention booklet will reduce the number of falls and fall rates when compared with usual care.
详细描述
This study is a multicenter parallel-group randomized trial among community-dwelling men and women aged 60 years and over, who have fallen at least once in the previous year. Participants will be recruited in multiple settings in Sao Paulo - Brazil and will be randomly allocated to a control group or an intervention group.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Community-dwelling older adults, men and women aged 60 and over who have fallen at least once in the last 12 months
排除标准
- •A previous diagnosis of dementia or a cognitive decline;
- •A previous stroke with a severe neurological impairment;
- •A progressive neurological disease;
- •A severe visual deficiency;
- •Any acute illness that the physician considers as an exercise contra-indication;
- •An acute vertigo or dizziness less than 3 months duration;
- •Inability to keep on standing, even with the use of a walking aid or other device;
- •Unable to communicate;
- •Those who are engaged in a regular exercise program, including physical therapy, with a frequency of equal to or more than twice a week such as: muscle strengthening, balance or gait exercise, Tai Chi and Yoga
结局指标
主要结局
rate of falls
时间窗: 12 months
Participants will receive instructions to fill in a monthly fall diary. They will receive telephone calls each month to ask for information regarding falls and its consequences, such as the mechanisms, environmental conditions, place (indoors or outdoors), activity during the fall and consequences.
proportion of fallers
时间窗: 12 months
Participants will receive instructions to fill in a monthly fall diary. They will receive telephone calls each month to ask for information regarding falls and its consequences, such as the mechanisms, environmental conditions, place (indoors or outdoors), activity during the fall and consequences.
次要结局
- The level of difficulty with daily tasks(baseline, 6 months, 12 months)
- Strength: Grip Strength with a dynamometer(Strength)
- Fall-related self-efficacy(baseline, 6 months, 12 months)
- Balance: Berg Balance Scale, Alternate step test, sit to stand test(baseline, 6 months and 12 months)
- Fall risk: Quick Falls Risk Assessment(baseline, 6 months, 12 months)
- Services use(6 months, 12 months)
研究者
Luiz Eugenio Garcez Leme
MD, PhD Professor
University of Sao Paulo