Clinical trial NCT04463797: 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
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Mild Cognitive Impairment
Keywords: Frailty
Mild cognitive impairment
Square-stepping exercise
Cognitive function
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 31
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Fried frailty criteria
timeFrame: 10 minutes
measure: The Montreal Cognitive Assessment
timeFrame: 8 minutes
Secondary outcomes:
measure: Frailty reverse rate
timeFrame: 2 minutes
measure: MCI reverse rate
timeFrame: 2 minutes
measure: Digit Span Test
timeFrame: 8 minutes
measure: Trail Making Test
timeFrame: 8 minutes
measure: Timed Up and Go Test
timeFrame: 5 minutes
measure: 6-minute walk test
timeFrame: 10 minutes
measure: Lower extremity strength
timeFrame: 5 minutes
measure: Brain activation
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang-Ming University
state: Beitou District
Study officials:
References: