Influence of Square-stepping Exercise on Brain Activation, Cognitive Function and Physical Performance in Frail Elders With MCI

Mild Cognitive Impairment Clinical Trial

Official title:

Influence of Square-stepping Exercise on Brain Activation, Cognitive Function and Physical Performance in Frail Elders With MCI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05173363
• Other study ID #: YM110152F
• Status: Recruiting
• Start date: February 9, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2022
• Source: National Yang Ming University
• Contact: Ray-Yau Wang, PhD
• Phone: +886-2-28267210
• Email: rywang[@]nycu.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical 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 frail elders with MCI.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Frailty
• Mild Cognitive Impairment

Locations

Country	Name	City	State
Taiwan	National Yang Ming Chiao Tung University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain activity	The brain activity will be measured under 3 tasks: usual walking, SSE-pattern1 (SSE1), and SSE-pattern 2 (SSE2)	20 minutes
Primary	SSE performance	The number of the correct steps that participants complete in 1 min during SSEs will be recorded	15 minutes
Primary	Montreal Cognitive Assessment	Global cognitive function	15 minutes
Primary	Trail making test	Executive function	5 minutes
Primary	Stroop color and word test	Executive function	5 minutes
Primary	Digit span test	Executive function	8 minutes
Primary	Timed up and go test	Dynamic balance and functional mobility	5 minutes
Primary	Berg balance scale	Balance and fall risk	15 minutes
Primary	Five times sit to stand test	Lower extremity strength	3 minutes