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Completed

NCT Number: NCT05173363

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

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.

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Key information

Conditions

Frailty Cognition Disorders Cognitive Dysfunction Mental Disorders Mild Cognitive Impairment Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

  2. SSE performance

    Time frame: 15 minutes

    The number of the correct steps that participants complete in 1 min during SSEs will be recorded

  3. Montreal Cognitive Assessment

    Time frame: 15 minutes

    Global cognitive function

  4. Trail making test

    Time frame: 5 minutes

    Executive function

  5. Stroop color and word test

    Time frame: 5 minutes

    Executive function

  6. Digit span test

    Time frame: 8 minutes

    Executive function

  7. Timed up and go test

    Time frame: 5 minutes

    Dynamic balance and functional mobility

  8. Berg balance scale

    Time frame: 15 minutes

    Balance and fall risk

  9. Five times sit to stand test

    Time frame: 3 minutes

    Lower extremity strength

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 29, 2021
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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