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临床试验/NCT05465720
NCT05465720尚未招募不适用

"Invisible" Balance Problems: the Comparison of Effects of Motor, Sensory and Cognitive Exercises on Falls Prevention in Community Dwelling Older Adults

Chung Shan Medical University0 个研究点目标入组 120 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
主要终点
Rate of near-falls

研究概览

简要总结

Motor, sensory, and cognitive functions all contribute to balance maintenance, and age causes deterioration in these functions with associated declines in balance ability and accidental falls. Relatively speaking, the sensory and cognitive functions are "invisible" in designing falls-prevention programs. The relative proportions of training of motor, sensory, and cognitive functions, for the most efficient falls-prevention program is a practical and important issue but has not been studied yet by directly comparing their intervention effects.

This three-year project aims to provide evidence base for relative proportions of motor, sensory, and cognitive training when designing falls-prevention programs. The crossover randomized controlled trial (RCT) will recruit 120 community-dwelling elderly adults from local community centers. There will two experimental groups- sensory and cognitive training, one control group- motor training, each for 60 minutes per session, 3 times a week, for 16 weeks. The three groups will be trained with task-oriented design of balance exercise but focusing on different aspects, i.e., training will begin in the ICF body function level (focusing on motor, sensory, or cognitive function) in the stance position and will end in the ICF activity level (balance or mobility activities focusing on motor, sensory, or cognitive function). The primary outcome measures are rates of falls and near-falls in the ICF participation level, and the secondary measures are balance/mobility performance and risk of falling in the ICF activity level.

In Taiwan, a great amount of expense is paid to prevent falls in the community setting. Through better understanding of the comparative intervention effects between motor, sensory, and cognitive training, this project hope to be able to suggest the relative proportions of motor, sensory, and cognitive training in falls-prevention exercise design.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (1) older than 60 years of age, (2) living in the community, (3) scored more than two in Mini-Cog assessment [51], and (4) able to walk independently or with minimal assistance in the community

排除标准

  • (1) an injury or musculoskeletal system disorder that would hamper their ability to conduct the physical tests, (2) acute heart attack in recent 3-6 months or unstable angina, (3) uncontrolled atrial or ventricular arrhythmias, (4) aortic dissecting aneurysm, (5) severe aortic stenosis, (6) acute endocarditis/pericarditis, (7) uncontrolled blood pressure higher than 180/110 mmHg, (8) acute thromboembolism, (9) acute or severe heart failure, (10) acute or severe respiratory failure, (11) uncontrolled postural hypotension, (12) uncontrolled acute decompensated diabetes mellitus or low blood sugar, (13) any other circumstance the doctors believe prevents dosing physical activity.

结局指标

主要结局

Rate of near-falls

时间窗: 3 minutes

participants will be interviewed for their falls history in the previous year

Taiwan International Physical Activity Questionnaire-Short Form

时间窗: 10 minutes

The frail criterion of the minimum weekly energy expenditure is 383 Kcal for men and 270 Kcal for women

Short form of Falls Efficacy Scale International

时间窗: 5 minutes

Participants will be asked to report their concerns about falling from 1 to 4 when performing seven activities, including indoor activities, outdoor activities, and social events

Rate of falls

时间窗: 3 minutes

participants will be interviewed for their falls history in the previous year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Huiya Chen

associate professor

Chung Shan Medical University

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