National Yang-Ming University
Taipei, Beitou District, 112, Taiwan
NCT Number: NCT04463797
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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Notify Me65 year–90 year
All sexes
Interventional
Not applicable
Taipei, Beitou District, 112, Taiwan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The square-stepping exercise is a low-cost indoor program to improve lower extremities fitness and cognitive function.
whole-body stretching and upper extremity strengthening
Time frame: 10 minutes
To assess the frailty status, score ranges from 1 to 5.
Time frame: 8 minutes
Evaluating global cognitive function, score ranges from 1 to 30.
Time frame: 2 minutes
The percentage of subjects in each group who reverse from prefrail to robust, and frail to prefrail or robust.
Time frame: 2 minutes
The percentage of subjects in each group who reverse from MCI to normal cognitive function.
Time frame: 8 minutes
Attention and memory
Time frame: 8 minutes
Executive function
Time frame: 5 minutes
Dynamic balance and mobility
Time frame: 10 minutes
Endurance and physical fitness
Time frame: 5 minutes
Measuring lower extremity strength of the subject with a dynamometer.
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).
National Yang Ming Chiao Tung University
Other
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