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Clinical Trials/NCT04463797
NCT04463797
Completed
Not Applicable

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

National Yang Ming Chiao Tung University1 site in 1 country31 target enrollmentAugust 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Frailty
Sponsor
National Yang Ming Chiao Tung University
Enrollment
31
Locations
1
Primary Endpoint
Fried frailty criteria
Status
Completed
Last Updated
11 months ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
August 15, 2020
End Date
December 31, 2024
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Fried frailty criteria

Time Frame: 10 minutes

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

The Montreal Cognitive Assessment

Time Frame: 8 minutes

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

Secondary Outcomes

  • 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)

Study Sites (1)

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