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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Frailty, Mild Cognitive Impairment

Intervention / Treatment
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* Other: Square-stepping exercise
* Other: Stretching and strengthening


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Square-stepping exercise group<br>Square-stepping exercise | Other: Square-stepping exercise<br>* The square-stepping exercise is a low-cost indoor program to improve lower extremities fitness and cognitive function.<br>|
| Active Comparator: Control group<br>Whole-body stretching and upper extremity strengthening | Other: Stretching and strengthening<br>* whole-body stretching and upper extremity strengthening<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fried frailty criteria | To assess the frailty status, score ranges from 1 to 5. | 10 minutes | 
| The Montreal Cognitive Assessment | Evaluating global cognitive function, score ranges from 1 to 30. | 8 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frailty reverse rate | The percentage of subjects in each group who reverse from prefrail to robust, and frail to prefrail or robust. | 2 minutes | 
| MCI reverse rate | The percentage of subjects in each group who reverse from MCI to normal cognitive function. | 2 minutes | 
| Digit Span Test | Attention and memory | 8 minutes | 
| Trail Making Test | Executive function | 8 minutes | 
| Timed Up and Go Test | Dynamic balance and mobility | 5 minutes | 
| 6-minute walk test | Endurance and physical fitness | 10 minutes | 
| Lower extremity strength | Measuring lower extremity strength of the subject with a dynamometer. | 5 minutes | 
| Brain activation | Measured by a wearable functional near-infrared spectroscopy system in bilateral prefrontal cortex (PFC), premotor cortex (PMC), supplementary motor area (SMA). | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frailty, Mild cognitive impairment, Square-stepping exercise, Cognitive function