FrailtyNCT05173363
Influence of Square-stepping Exercise on Brain Activation, Cognitive Function and Physical Performance in Frail Elders With MCI
An observational study of Frailty and Mild Cognitive Impairment, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
This study is to elucidate the possible mechanisms of SSE by examining brain activation differences between SSE patterns and usual walking, as well as the relationship between brain activity and SSE performance, between cognitive function and SSE performance, and between physical performance and SSE performance in… Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Frailty, Mild Cognitive Impairment
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Feb 2022to 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
- No healthy volunteers
- Older adult
Study population: Older adults with frailty and mild cognitive impairment
Who may be able to join
- Age between 65 and 90 years old
- Presence of at least 1 characteristic of the Fried frailty criteria
- Mini-mental state examination score equal to or more than 24
- Montreal Cognitive Assessment score less than 26
- Ability to walk independently for 1 min without assistive devices
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
This study is to elucidate the possible mechanisms of SSE by examining brain activation differences between SSE patterns and usual walking, as well as the relationship between brain activity and SSE performance, between cognitive function and SSE performance, and between physical performance and SSE performance in frail elders with MCI.
Read the detailed description
Background:
Both frailty and MCI exert negative impact on motor and cognitive function, which increase the risks of fall and adverse health condition. SSE has been proved to be an effective intervention for motor and cognitive function in older adults. However, the underlying mechanisms of SSE still remain undetermined for its possible effects. This study aims to elucidate the possible mechanisms of SSE in frail elders with MCI.
Methods:
This is a cross-sectional study. The inclusion criteria are: (1) age between 65 and 90 years old, (2) the presence of at least 1 characteristic of the Fried frailty criteria, (3) with mini-mental state examination (MMSE) score≧24 and Montreal Cognitive Assessment (MoCA) score <26 (MCI criteria), and (4) ability to walk independently for 1 min without assistive devices. The exclusion criteria are: (1) central nervous system disorders (such as stroke, Parkinson's disease, spinal cord injury), and (2) any unstable physical condition, psychiatric disorder, and other neurological disorder or diagnosed with learning disability which may affect participating this study. Brain activity during SSE and usual walking, SSE performance, physical performance, and cognitive function are measured. The purpose of this study is to elucidate the possible mechanisms of SSE by examining brain activation differences between SSE patterns and usual walking, as well as the relationship between brain activity and SSE performance, between cognitive function and SSE performance, and between physical performance and SSE performance in frail elders with MCI.
- Conditions
- Frailty, Mild Cognitive Impairment
- Keywords
- Square-stepping exercise, Frailty, Mild Cognitive Impairment
- Medical subject headings
- Frailty, Cognitive Dysfunction
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 |
|---|---|---|
| Older adults with frailty and mild cognitive impairment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activity
The brain activity will be measured under 3 tasks: usual walking, SSE-pattern1 (SSE1), and SSE-pattern 2 (SSE2)
Measured: 20 minutes
SSE performance
The number of the correct steps that participants complete in 1 min during SSEs will be recorded
Measured: 15 minutes
Montreal Cognitive Assessment
Global cognitive function
Measured: 15 minutes
Trail making test
Executive function
Measured: 5 minutes
Stroop color and word test
Executive function
Measured: 5 minutes
Digit span test
Executive function
Measured: 8 minutes
Timed up and go test
Dynamic balance and functional mobility
Measured: 5 minutes
Berg balance scale
Balance and fall risk
Measured: 15 minutes
Five times sit to stand test
Lower extremity strength
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start9 Feb 2022
- 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 FrailtyStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173363
- Sponsor's protocol ID
- YM110152F
- Status last verified
- Sep 2022
- First submitted
- 5 Dec 2021
- Last updated
- 29 May 2025
- Results posted
- 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 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Square-stepping Exercise on Brain Activation, Cognitive Function and Physical Performance in Frail Elders With MCI
- ClinicalTrials.gov ID
- NCT05173363
- Acronym / sponsor ID
- YM110152F
- Conditions
- Frailty, Mild Cognitive Impairment
- Keywords
- Square-stepping exercise, Frailty, Mild Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 29 Dec 2021 (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.
This study is to elucidate the possible mechanisms of SSE by examining brain activation differences between SSE patterns and usual walking, as well as the relationship between brain activity and SSE performance, between cognitive function and SSE performance, and between physical performance and SSE performance in frail elders with MCI.
Detailed description
Background:
Both frailty and MCI exert negative impact on motor and cognitive function, which increase the risks of fall and adverse health condition. SSE has been proved to be an effective intervention for motor and cognitive function in older adults. However, the underlying mechanisms of SSE still remain undetermined for its possible effects. This study aims to elucidate the possible mechanisms of SSE in frail elders with MCI.
Methods:
This is a cross-sectional study. The inclusion criteria are: (1) age between 65 and 90 years old, (2) the presence of at least 1 characteristic of the Fried frailty criteria, (3) with mini-mental state examination (MMSE) score≧24 and Montreal Cognitive Assessment (MoCA) score <26 (MCI criteria), and (4) ability to walk independently for 1 min without assistive devices. The exclusion criteria are: (1) central nervous system disorders (such as stroke, Parkinson's disease, spinal cord injury), and (2) any unstable physical condition, psychiatric disorder, and other neurological disorder or diagnosed with learning disability which may affect participating this study. Brain activity during SSE and usual walking, SSE performance, physical performance, and cognitive function are measured. The purpose of this study is to elucidate the possible mechanisms of SSE by examining brain activation differences between SSE patterns and usual walking, as well as the relationship between brain activity and SSE performance, between cognitive function and SSE performance, and between physical performance and SSE performance in frail elders with MCI.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older adults with frailty and mild cognitive impairment | – | – |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older adults with frailty and mild cognitive impairment
Key inclusion criteria (5 listed)
- Age between 65 and 90 years old
- Presence of at least 1 characteristic of the Fried frailty criteria
- Mini-mental state examination score equal to or more than 24
- Montreal Cognitive Assessment score less than 26
- Ability to walk independently for 1 min without assistive devices
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: 20 minutes
The brain activity will be measured under 3 tasks: usual walking, SSE-pattern1 (SSE1), and SSE-pattern 2 (SSE2)
SSE performance
Time frame: 15 minutes
The number of the correct steps that participants complete in 1 min during SSEs will be recorded
Montreal Cognitive Assessment
Time frame: 15 minutes
Global cognitive function
Trail making test
Time frame: 5 minutes
Executive function
Stroop color and word test
Time frame: 5 minutes
Executive function
Digit span test
Time frame: 8 minutes
Executive function
Timed up and go test
Time frame: 5 minutes
Dynamic balance and functional mobility
Berg balance scale
Time frame: 15 minutes
Balance and fall risk
Five times sit to stand test
Time frame: 3 minutes
Lower extremity strength
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 29 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Frailty and Mild Cognitive Impairment, 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 5 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 29 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: 20 minutes). The study lists 9 primary outcomes in all. 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 29 May 2025.