跳至主要内容
临床试验/NCT04463797
NCT04463797已完成不适用

Effects of Square-stepping Exercise on Frailty and Cognitive Function in Elderly With Frailty and MCI

National Yang Ming Chiao Tung University1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2020年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
1
主要终点
Fried frailty criteria

研究概览

简要总结

This is a single-blinded, randomized controlled trail with pre- and post-measurements. The inclusion criteria are: (1) age between 65 to 90 years old, (2) the presence of at least one of the 5 physical characteristics defined by Fried, (3) with mini-mental state examination (MMSE) score≧24 and Montreal cognitive assessment (MoCA) score < 26, and (4) ability to walk independently for 1 min without assistive devices. The exclusion criteria are: unstable physical condition, any neurological, psychiatric disorder, or diagnosed with learning disability which may affect participation in this study. Twenty-eight elderly will be recruited, and randomly assigned to one of two groups: square-stepping exercise (SSE) group (n=14) or control group (n=14). The intervention for both group will be 50 minutes per session, 3 sessions per week for 8 weeks. The primary outcomes include frailty status indicated by Fried frailty criteria, and global cognitive function indicated by MoCA score. Secondary outcomes include frailty and MCI reverse rate, attention and memory, executive function, physical performance, and brain activation.

详细描述

Background and purpose:

Frailty is a continuous decline of multiple physiological systems along with aging. Common characteristics of frailty are fatigue, weakness, weight loss, slowness, and low physical activity. Brain changes accompanying frailty may lead to cognitive decline. Moreover, evidence showed positive relations between frailty and cognitive decline. Frailty with cognitive decline increases the risk of various adverse outcomes, such as disability, hospitalization, incidence of dementia, loss of daily activity functioning, and poor quality of life. Physical exercise training is a common intervention for frail elderly; however, most studies applying physical exercise to frail elderly are for enhancing physical performance, few are for improving cognitive function. On the other hand, the square-stepping exercise has been proven to be beneficial to healthy older adults for both physical performance and cognitive function, but it's application for frail elderly is scarce. Therefore, the purpose of this study is to explore the effects of the square-stepping exercise on frailty and cognitive function in elderly with frailty and mild cognitive impairment (MCI).

Method:

This is a single-blinded, randomized controlled trail with pre- and post-measurements. The inclusion criteria are: (1) age between 65 to 90 years old, (2) the presence of at least one of the 5 physical characteristics defined by Fried, (3) with mini-mental state examination (MMSE) score≧24 and Montreal cognitive assessment (MoCA) score < 26, and (4) ability to walk independently for 1 min without assistive devices. The exclusion criteria are: unstable physical condition, any neurological, psychiatric disorder, or diagnosed with learning disability which may affect participation in this study. Twenty-eight elderly will be recruited, and randomly assigned to one of two groups: square-stepping exercise (SSE) group (n=14) or control group (n=14). The intervention for both group will be 50 minutes per session, 3 sessions per week for 8 weeks. The primary outcomes include frailty status indicated by Fried frailty criteria, and global cognitive function indicated by MoCA score. Secondary outcomes include frailty and MCI reverse rate, attention and memory, executive function, physical performance, and brain activation.

SPSS 25.0 will be used for data analysis, with significant level set at 0.05. Repeated measures two-way analysis of variance (ANOVA) with Tukey's post-hoc analysis will be used to compare between time (pre-test, post-test) and between groups. Chi-square test (χ2 test) will be applied comparing data of frailty/ MCI reverse rate.

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
Single (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 90 Years(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age between 65 to 90 years old
  • •Presence of at least one of the 5 physical characteristics of frailty defined by Fried
  • •Mini-mental state examination (MMSE) score more than or equal to 24
  • •Montreal cognitive assessment (MoCA) score less than 26
  • •Ability to walk independently for 1 min without assistive devices

排除标准

  • •Unstable physical condition
  • •Any neurological or psychiatric disorder
  • •Diagnosed with learning disability which may affect participation in this study

研究组 & 干预措施

Square-stepping exercise group

Experimental

Square-stepping exercise

干预措施: Square-stepping exercise (Other)

Control group

Active Comparator

Whole-body stretching and upper extremity strengthening

干预措施: Stretching and strengthening (Other)

结局指标

主要结局

Fried frailty criteria

时间窗: 10 minutes

To assess the frailty status, score ranges from 1 to 5.

The Montreal Cognitive Assessment

时间窗: 8 minutes

Evaluating global cognitive function, score ranges from 1 to 30.

次要结局

  • Timed Up and Go Test(5 minutes)
  • Digit Span Test(8 minutes)
  • Trail Making Test(8 minutes)
  • 6-minute walk test(10 minutes)
  • Lower extremity strength(5 minutes)
  • MCI reverse rate(2 minutes)
  • Frailty reverse rate(2 minutes)
  • Brain activation(30 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Effects of Square-stepping Exercise on Frailty and... | 临床试验