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

Not Applicable
Recruiting
Conditions
Mild Cognitive Impairment
Frailty
Interventions
Other: Square-stepping exercise
Other: Stretching and strengthening
Registration Number
NCT04463797
Lead Sponsor
National Yang Ming Chiao Tung University
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
28
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Square-stepping exercise groupSquare-stepping exerciseSquare-stepping exercise
Control groupStretching and strengtheningWhole-body stretching and upper extremity strengthening
Primary Outcome Measures
NameTimeMethod
Fried frailty criteria10 minutes

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

The Montreal Cognitive Assessment8 minutes

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

Secondary Outcome Measures
NameTimeMethod
Timed Up and Go Test5 minutes

Dynamic balance and mobility

Digit Span Test8 minutes

Attention and memory

Trail Making Test8 minutes

Executive function

6-minute walk test10 minutes

Endurance and physical fitness

Lower extremity strength5 minutes

Measuring lower extremity strength of the subject with a dynamometer.

MCI reverse rate2 minutes

The percentage of subjects in each group who reverse from MCI to normal cognitive function.

Frailty reverse rate2 minutes

The percentage of subjects in each group who reverse from prefrail to robust, and frail to prefrail or robust.

Brain activation30 minutes

Measured by a wearable functional near-infrared spectroscopy system in bilateral prefrontal cortex (PFC), premotor cortex (PMC), supplementary motor area (SMA).

Trial Locations

Locations (1)

National Yang-Ming University

🇨🇳

Taipei, Beitou District, Taiwan

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