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

Primary Purpose

Frailty, Mild Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Square-stepping exercise
Stretching and strengthening
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frailty focused on measuring Frailty, Mild cognitive impairment, Square-stepping exercise, Cognitive function

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Yang-Ming UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Square-stepping exercise group

Control group

Arm Description

Square-stepping exercise

Whole-body stretching and upper extremity strengthening

Outcomes

Primary Outcome Measures

Fried frailty criteria
To assess the frailty status, score ranges from 1 to 5.
The Montreal Cognitive Assessment
Evaluating global cognitive function, score ranges from 1 to 30.

Secondary Outcome Measures

Frailty reverse rate
The percentage of subjects in each group who reverse from prefrail to robust, and frail to prefrail or robust.
MCI reverse rate
The percentage of subjects in each group who reverse from MCI to normal cognitive function.
Digit Span Test
Attention and memory
Trail Making Test
Executive function
Timed Up and Go Test
Dynamic balance and mobility
6-minute walk test
Endurance and physical fitness
Lower extremity strength
Measuring lower extremity strength of the subject with a dynamometer.
Brain activation
Measured by a wearable functional near-infrared spectroscopy system in bilateral prefrontal cortex (PFC), premotor cortex (PMC), supplementary motor area (SMA).

Full Information

First Posted
July 6, 2020
Last Updated
October 6, 2022
Sponsor
National Yang Ming University
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1. Study Identification

Unique Protocol Identification Number
NCT04463797
Brief Title
Effects of Square-stepping Exercise on Frailty and Cognitive Function in Elderly With Frailty and MCI
Official Title
Effects of Square-stepping Exercise on Frailty and Cognitive Function in Elderly With Frailty and MCI
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2020 (Actual)
Primary Completion Date
May 28, 2023 (Anticipated)
Study Completion Date
May 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Yang Ming University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Mild Cognitive Impairment
Keywords
Frailty, Mild cognitive impairment, Square-stepping exercise, Cognitive function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Square-stepping exercise group
Arm Type
Experimental
Arm Description
Square-stepping exercise
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Whole-body stretching and upper extremity strengthening
Intervention Type
Other
Intervention Name(s)
Square-stepping exercise
Intervention Description
The square-stepping exercise is a low-cost indoor program to improve lower extremities fitness and cognitive function.
Intervention Type
Other
Intervention Name(s)
Stretching and strengthening
Intervention Description
whole-body stretching and upper extremity strengthening
Primary Outcome Measure Information:
Title
Fried frailty criteria
Description
To assess the frailty status, score ranges from 1 to 5.
Time Frame
10 minutes
Title
The Montreal Cognitive Assessment
Description
Evaluating global cognitive function, score ranges from 1 to 30.
Time Frame
8 minutes
Secondary Outcome Measure Information:
Title
Frailty reverse rate
Description
The percentage of subjects in each group who reverse from prefrail to robust, and frail to prefrail or robust.
Time Frame
2 minutes
Title
MCI reverse rate
Description
The percentage of subjects in each group who reverse from MCI to normal cognitive function.
Time Frame
2 minutes
Title
Digit Span Test
Description
Attention and memory
Time Frame
8 minutes
Title
Trail Making Test
Description
Executive function
Time Frame
8 minutes
Title
Timed Up and Go Test
Description
Dynamic balance and mobility
Time Frame
5 minutes
Title
6-minute walk test
Description
Endurance and physical fitness
Time Frame
10 minutes
Title
Lower extremity strength
Description
Measuring lower extremity strength of the subject with a dynamometer.
Time Frame
5 minutes
Title
Brain activation
Description
Measured by a wearable functional near-infrared spectroscopy system in bilateral prefrontal cortex (PFC), premotor cortex (PMC), supplementary motor area (SMA).
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ray-Yau Wang, Professor
Phone
+886-2-2826-7210
Email
rywang@nycu.edu.tw
Facility Information:
Facility Name
National Yang-Ming University
City
Taipei
State/Province
Beitou District
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ray-Yau Wang, Professor
Phone
+886-2-2826-7210
Email
rywang@nycu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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