Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04463797 |
| Other study ID # |
YM109044F |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 15, 2020 |
| Est. completion date |
May 28, 2023 |
Study information
| Verified date |
September 2022 |
| Source |
National Yang Ming University |
| Contact |
Ray-Yau Wang, Professor |
| Phone |
+886-2-2826-7210 |
| Email |
rywang[@]nycu.edu.tw |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
