Older AdultsNCT05891574
Influence and Relationships Between Square-stepping Exercise and Brain Activation, Cognitive Function, Physical Performance in Healthy Older Adults
An observational study of Older Adults and Age Problem, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Older Adults, Age Problem
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2023to 28 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Healthy older adults
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Older Adults, Age Problem
- Keywords
- older adults, square-stepping exercise, brain activation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at the enrollment (1 day)
Secondary outcomes (8)
SSE performance
The number of the correct steps that participants complete in 1 min during SSEs will be recorded. The average of the two trials for each pattern will be calculated as SSE performance for data analysis
Measured: at the enrollment (1 day)
Montreal Cognitive Assessment
The MoCA Taiwanese Version is used to evaluate global cognitive function. It consists of eight cognitive domains, including visuospatial/ executive function, naming, memory, attention, language, abstraction, delayed recall, orientation.
Measured: at the enrollment (1 day)
Trail Making Test
The Trail Making Test (TMT) consists part A and B, and is one of the most widely used test for executive function especially in attention, sequencing and shifting domains.
Measured: at the enrollment (1 day)
Stroop Color and Word Test
The Stroop Color and Word Test (SCWT) is used to measure executive function especially the selective attention with high test-retest reliability of 0.91. During the test, subject is asked to (1) name the word in congruent color and (2) name the color of the ink in which incongruent color words are printed. The numbers of correct answers within 45 seconds are recorded, with the congruent and incongruent part scored separately.
Measured: at the enrollment (1 day)
Digit span test
A subtest in Wechsler Adult Intelligence Scale Revised and is commonly used for testing attention and working memory with the test-retest reliability of 0.83. The test is composed of forward span and backward span. In forward recall, participants have to repeat the exact sequence that assessor read out. In backward span, after the forward span was completed, the participants have to repeat the sequence in reverse. The sequence ranges from 3-digit to 9-digit for forward, and 2-digit to 8-digit for backward. The total score will be the summation of forward and backward.
Measured: at the enrollment (1 day)
Timed up and go test
The timed up and go test (TUG) is used to evaluate dynamic balance and functional mobility (ICC=0.98)62. The participant is instructed to stand up from a chair, walk as fast as possible for 3 meters, turn, walk back to the chair, and sit down. The time needed to complete the test will be recorded. The test will be repeated twice, with a 30-second rest in between, and the average will be analyzed.
Measured: at the enrollment (1 day)
Berg balance scale
Berg-balance scale (BBS) is a 14-item measurement of balance and fall risk with test and retest reliability of 0.886. Each item is scored on a 5-point scale, ranging from 0 to 4. Total score of BBS ranges from 0 to 56.
Measured: at the enrollment (1 day)
Five times sit to stand test
The five times sit to stand test (FSST) is used to indicate the lower extremity strength with test and retest reliability of 0.89. Participant is instructed to fold arms across chest, and performs sit-to-stand five times as quickly as possible. The test will be done twice, with a 30-second rest in between, and average time spent of the two trials will be analyzed.
Measured: at the enrollment (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Jun 2023
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ray-Yau Wang, National Yang Ming Chiao Tung University
- Investigators
- Ray-Yau Wang, Principal investigator, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891574
- Sponsor's protocol ID
- NYCU112078AE
- Status last verified
- Jun 2023
- First submitted
- 15 May 2023
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence and Relationships Between Square-stepping Exercise and Brain Activation, Cognitive Function, Physical Performance in Healthy Older Adults
- ClinicalTrials.gov ID
- NCT05891574
- Acronym / sponsor ID
- NYCU112078AE
- Conditions
- Older Adults, Age Problem
- Keywords
- older adults, square-stepping exercise, brain activation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Healthy older adults
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Brain activity
Time frame: at the enrollment (1 day)
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.
8 secondary outcomes
SSE performance
Time frame: at the enrollment (1 day)
Montreal Cognitive Assessment
Time frame: at the enrollment (1 day)
Trail Making Test
Time frame: at the enrollment (1 day)
Stroop Color and Word Test
Time frame: at the enrollment (1 day)
Digit span test
Time frame: at the enrollment (1 day)
Timed up and go test
Time frame: at the enrollment (1 day)
Berg balance scale
Time frame: at the enrollment (1 day)
Five times sit to stand test
Time frame: at the enrollment (1 day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ray-Yau Wang principal investigator
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Older Adults and Age Problem, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain activity (time frame: at the enrollment (1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.