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Completed

NCT Number: NCT04463797

Effects of Square-stepping Exercise on Frailty and Cognitive Function in Elderly With Frailty and MCI

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.

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Key information

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Yang-Ming University

Taipei, Beitou District, 112, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • Unstable physical condition
  • Any neurological or psychiatric disorder
  • Diagnosed with learning disability which may affect participation in this study

Treatment and study plan

Square-stepping exercise

Other

The square-stepping exercise is a low-cost indoor program to improve lower extremities fitness and cognitive function.

stretching and strengthening

Other

whole-body stretching and upper extremity strengthening

Primary outcomes

  1. Fried frailty criteria

    Time frame: 10 minutes

    To assess the frailty status, score ranges from 1 to 5.

  2. The Montreal Cognitive Assessment

    Time frame: 8 minutes

    Evaluating global cognitive function, score ranges from 1 to 30.

Secondary outcomes

  1. Frailty reverse rate

    Time frame: 2 minutes

    The percentage of subjects in each group who reverse from prefrail to robust, and frail to prefrail or robust.

  2. MCI reverse rate

    Time frame: 2 minutes

    The percentage of subjects in each group who reverse from MCI to normal cognitive function.

  3. Digit Span Test

    Time frame: 8 minutes

    Attention and memory

  4. Trail Making Test

    Time frame: 8 minutes

    Executive function

  5. Timed Up and Go Test

    Time frame: 5 minutes

    Dynamic balance and mobility

  6. 6-minute walk test

    Time frame: 10 minutes

    Endurance and physical fitness

  7. Lower extremity strength

    Time frame: 5 minutes

    Measuring lower extremity strength of the subject with a dynamometer.

  8. Brain activation

    Time frame: 30 minutes

    Measured by a wearable functional near-infrared spectroscopy system in bilateral prefrontal cortex (PFC), premotor cortex (PMC), supplementary motor area (SMA).

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jul 9, 2020
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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