NCT05891574

Brief Summary

Background and purposes: Square-stepping exercise (SSE) has been proved to be an effective intervention for motor and cognitive function in older adults. However, the underlying mechanism of SSE still remains undetermined. Therefore, the aim of this study is to elucidate the possible mechanism of SSE in healthy older adults. Methods: This is a cross-sectional study. Inclusion criteria are: (1) age between 65 and 90 years, (2) no frailty indicated by Fried frailty criteria, (3) mini-mental state examination score≧24 and Montreal Cognitive Assessment score≧26, (4) ability to walk independently for 1 min. Brain activation differences between SSE patterns and usual walking, as well as relationships between brain activity, cognitive function, physical performance and SSE performance will be examined. This study will address both cognitive and motor aspects of possible mechanism in SSE. SPSS version 25.0 (SPSS Inc., Chicago, IL, USA) will be used to analyze the collected data in this study. One-way ANOVA with repeated measures is used to evaluate the differences in brain activation among usual walking, SSE-pattern 1, and SSE-pattern 2, with Bonferroni test for post hoc analysis. The Pearson correlation coefficient will be used to establish the relationships between brain activity and SSEs performance, between cognitive function and SSEs performance, and between motor function and SSEs performance. The significant level is set at p\< .05.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

May 25, 2025

Status Verified

June 1, 2023

Enrollment Period

9 months

First QC Date

May 15, 2023

Last Update Submit

May 21, 2025

Conditions

Keywords

older adultssquare-stepping exercisebrain activation

Outcome Measures

Primary Outcomes (1)

  • Brain activity

    The brain (bilateral PFC, PMC, SMA) activity indicated by brain oxygenation will be measured by a wearable functional near-infrared spectroscopy system under 3 conditions: usual walking, SSE-pattern 1 (SSE1), and SSE-pattern 2 (SSE2). * Usual walking: participants walk back and forth at their comfortable speed on a 25-m walkway for 1 min. * SSE1: participants perform SSE pattern 1 on the SSE mat at their comfortable speed, and repeat the pattern for 1 min. * SSE2: participants perform SSE pattern 2 on the SSE mat at their comfortable speed, and repeat the pattern for 1 min.

    at the enrollment (1 day)

Secondary Outcomes (8)

  • SSE performance

    at the enrollment (1 day)

  • Montreal Cognitive Assessment

    at the enrollment (1 day)

  • Trail Making Test

    at the enrollment (1 day)

  • Stroop Color and Word Test

    at the enrollment (1 day)

  • Digit span test

    at the enrollment (1 day)

  • +3 more secondary outcomes

Study Arms (1)

healthy older adults

* Age between 65 and 90 years * No frailty indicated by Fried frailty criteria * Mini-mental state examination score equals to or more than 24, and Montreal Cognitive Assessment score equals to or more than 26 * Ability to walk independently for 1 min

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy older adults

You may qualify if:

  • Age between 65 and 90 years
  • No frailty indicated by Fried frailty criteria
  • Mini-mental state examination score equals to or more than 24, and Montreal Cognitive Assessment score equals to or more than 26
  • Ability to walk independently for 1 min

You may not qualify if:

  • Central nervous system disorders (such as stroke, Parkinson's disease, spinal cord injury)
  • Any unstable physical condition, psychiatric disorder, and other neurological disorder, or diagnosed with learning disability which may affect participating this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, 112304, Taiwan

Location

Study Officials

  • Ray-Yau Wang

    National Yang Ming Chiao Tung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 15, 2023

First Posted

June 7, 2023

Study Start

June 1, 2023

Primary Completion

February 28, 2024

Study Completion

February 28, 2024

Last Updated

May 25, 2025

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations