FrailtyNCT04463797
Effects of Square-stepping Exercise on Frailty and Cognitive Function in Elderly With Frailty and MCI
A study testing Square-stepping exercise and Stretching and strengthening in people with Frailty and Mild Cognitive Impairment, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Frailty, Mild Cognitive Impairment
- What is being tested?
- Square-stepping exercise and Stretching and strengthening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Aug 2020to 31 Dec 2024
- Phase
- Interventional
- 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
Who may be able to join
- 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
Who cannot join
- Unstable physical condition
- Any neurological or psychiatric disorder
- Diagnosed with learning disability which may affect participation in this study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Frailty, Mild Cognitive Impairment
- Being tested
- Square-stepping exercise, Stretching and strengthening
- Keywords
- Frailty, Mild cognitive impairment, Square-stepping exercise, Cognitive function
- 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.
Square-stepping exerciseOther
The square-stepping exercise is a low-cost indoor program to improve lower extremities fitness and cognitive function.
Stretching and strengtheningOther
whole-body stretching and upper extremity strengthening
| Study group | Role | What they receive |
|---|---|---|
| Square-stepping exercise group | Experimental | Square-stepping exercise Receives: Other: Square-stepping exercise |
| Control group | Active comparator | Whole-body stretching and upper extremity strengthening Receives: Other: Stretching and strengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fried frailty criteria
To assess the frailty status, score ranges from 1 to 5.
Measured: 10 minutes
The Montreal Cognitive Assessment
Evaluating global cognitive function, score ranges from 1 to 30.
Measured: 8 minutes
Secondary outcomes (8)
Frailty reverse rate
The percentage of subjects in each group who reverse from prefrail to robust, and frail to prefrail or robust.
Measured: 2 minutes
MCI reverse rate
The percentage of subjects in each group who reverse from MCI to normal cognitive function.
Measured: 2 minutes
Digit Span Test
Attention and memory
Measured: 8 minutes
Trail Making Test
Executive function
Measured: 8 minutes
Timed Up and Go Test
Dynamic balance and mobility
Measured: 5 minutes
6-minute walk test
Endurance and physical fitness
Measured: 10 minutes
Lower extremity strength
Measuring lower extremity strength of the subject with a dynamometer.
Measured: 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).
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start15 Aug 2020
- Primary completion31 Dec 2024
- Study completion31 Dec 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 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
- NCT04463797
- Sponsor's protocol ID
- YM109044F
- Status last verified
- Sep 2022
- First submitted
- 6 Jul 2020
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- Effects of Square-stepping Exercise on Frailty and Cognitive Function in Elderly With Frailty and MCI
- ClinicalTrials.gov ID
- NCT04463797
- Acronym / sponsor ID
- YM109044F
- Conditions
- Frailty, Mild Cognitive Impairment
- Keywords
- Frailty, Mild cognitive impairment, Square-stepping exercise, Cognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 9 Jul 2020 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Square-stepping exercise group | Experimental | Other: Square-stepping exerciseSquare-stepping exercise |
| Control group | Active comparator | Other: Stretching and strengtheningWhole-body stretching and upper extremity strengthening |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Unstable physical condition
- Any neurological or psychiatric disorder
- Diagnosed with learning disability which may affect participation in 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Square-stepping exerciseThe square-stepping exercise is a low-cost indoor program to improve lower extremities fitness and cognitive function. | Other | Square-stepping exercise group |
| Stretching and strengtheningwhole-body stretching and upper extremity strengthening | Other | Control group |
Primary outcome
Fried frailty criteria
Time frame: 10 minutes
To assess the frailty status, score ranges from 1 to 5.
The Montreal Cognitive Assessment
Time frame: 8 minutes
Evaluating global cognitive function, score ranges from 1 to 30.
8 secondary outcomes
Frailty reverse rate
Time frame: 2 minutes
MCI reverse rate
Time frame: 2 minutes
Digit Span Test
Time frame: 8 minutes
Trail Making Test
Time frame: 8 minutes
Timed Up and Go Test
Time frame: 5 minutes
6-minute walk test
Time frame: 10 minutes
Lower extremity strength
Time frame: 5 minutes
Brain activation
Time frame: 30 minutes
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: Undecided
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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?
A study testing Square-stepping exercise and Stretching and strengthening in people with 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 3 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?
Fried frailty criteria (time frame: 10 minutes). The study lists 2 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.