NCT05173363

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 29, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

February 9, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

May 29, 2025

Status Verified

September 1, 2022

Enrollment Period

2.1 years

First QC Date

December 5, 2021

Last Update Submit

May 23, 2025

Conditions

Keywords

Square-stepping exerciseFrailtyMild Cognitive Impairment

Outcome Measures

Primary Outcomes (9)

  • Brain activity

    The brain activity will be measured under 3 tasks: usual walking, SSE-pattern1 (SSE1), and SSE-pattern 2 (SSE2)

    20 minutes

  • SSE performance

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

    15 minutes

  • Montreal Cognitive Assessment

    Global cognitive function

    15 minutes

  • Trail making test

    Executive function

    5 minutes

  • Stroop color and word test

    Executive function

    5 minutes

  • Digit span test

    Executive function

    8 minutes

  • Timed up and go test

    Dynamic balance and functional mobility

    5 minutes

  • Berg balance scale

    Balance and fall risk

    15 minutes

  • Five times sit to stand test

    Lower extremity strength

    3 minutes

Study Arms (1)

Older adults with frailty and mild cognitive impairment

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Older adults with frailty and mild cognitive impairment

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

FrailtyCognitive Dysfunction

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2021

First Posted

December 29, 2021

Study Start

February 9, 2022

Primary Completion

February 28, 2024

Study Completion

February 28, 2024

Last Updated

May 29, 2025

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations