- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05173363
Influence of Square-stepping Exercise on Brain Activation, Cognitive Function and Physical Performance in Frail Elders With MCI
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Ray-Yau Wang, PhD
- Phone Number: +886-2-28267210
- Email: rywang@nycu.edu.tw
Study Locations
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Taipei, Taiwan, 112
- Recruiting
- National Yang Ming Chiao Tung University
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Contact:
- Ray-Yau Wang, PhD
- Phone Number: +886-2-28267210
- Email: rywang@nycu.edu.tw
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Older adults with frailty and mild cognitive impairment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
20 minutes
|
SSE performance
Time Frame: 15 minutes
|
The number of the correct steps that participants complete in 1 min during SSEs will be recorded
|
15 minutes
|
Montreal Cognitive Assessment
Time Frame: 15 minutes
|
Global cognitive function
|
15 minutes
|
Trail making test
Time Frame: 5 minutes
|
Executive function
|
5 minutes
|
Stroop color and word test
Time Frame: 5 minutes
|
Executive function
|
5 minutes
|
Digit span test
Time Frame: 8 minutes
|
Executive function
|
8 minutes
|
Timed up and go test
Time Frame: 5 minutes
|
Dynamic balance and functional mobility
|
5 minutes
|
Berg balance scale
Time Frame: 15 minutes
|
Balance and fall risk
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15 minutes
|
Five times sit to stand test
Time Frame: 3 minutes
|
Lower extremity strength
|
3 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YM110152F
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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