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

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.

Study Overview

• Status: Completed
• Conditions: Frailty; Mild Cognitive Impairment
• Intervention / Treatment: Other: Square-stepping exercise; Other: Stretching and strengthening

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Beitou District
    • Taipei, Beitou District, Taiwan, 112
      • National Yang-Ming University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Yang Ming Chiao Tung University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2020
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: July 6, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 23, 2025
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Cognitive function; Frailty; Mild cognitive impairment; Square-stepping exercise
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neurocognitive Disorders; Cognition Disorders; Frailty; Cognitive Dysfunction
• Other Study ID Numbers: YM109044F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No