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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04463797
Enrollment
31
Registered
2020-07-09
Start date
2020-08-15
Completion date
2024-12-31
Last updated
2025-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty, Mild Cognitive Impairment

Keywords

Frailty, Mild cognitive impairment, Square-stepping exercise, Cognitive function

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.

Interventions

The square-stepping exercise is a low-cost indoor program to improve lower extremities fitness and cognitive function.

whole-body stretching and upper extremity strengthening

Sponsors

National Yang Ming Chiao Tung University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fried frailty criteria10 minutesTo assess the frailty status, score ranges from 1 to 5.
The Montreal Cognitive Assessment8 minutesEvaluating global cognitive function, score ranges from 1 to 30.

Secondary

MeasureTime frameDescription
Digit Span Test8 minutesAttention and memory
Trail Making Test8 minutesExecutive function
Timed Up and Go Test5 minutesDynamic balance and mobility
Frailty reverse rate2 minutesThe percentage of subjects in each group who reverse from prefrail to robust, and frail to prefrail or robust.
Lower extremity strength5 minutesMeasuring lower extremity strength of the subject with a dynamometer.
Brain activation30 minutesMeasured by a wearable functional near-infrared spectroscopy system in bilateral prefrontal cortex (PFC), premotor cortex (PMC), supplementary motor area (SMA).
6-minute walk test10 minutesEndurance and physical fitness
MCI reverse rate2 minutesThe percentage of subjects in each group who reverse from MCI to normal cognitive function.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026