跳至主要内容
临床试验/NCT06797440
NCT06797440尚未招募不适用

The Effect of Dual Tasks of Digital Technology on Cognitive Function and Physical Activity in the Older Adults With Cognitive Frailty - A Randomized Controlled Trial

National Taipei University of Nursing and Health Sciences1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年4月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Taiwanese version of the Montreal Cognitive Assessment (MoCA-T)

研究概览

简要总结

Background: Cognitive frailty is a state that combines physical weakness and cognitive impairment. As age increases, the prevalence rate also increases. Older adults with cognitive frailty are prone to falls, limited or degraded physical functions, and are at high risk of becoming disabled. It is an essential predictor of dementia and mortality. There are currently very few randomized controlled trial studies on cognitive frailty abroad. Although there are many related studies on senile frailty in Taiwan, most studies examine cognitive function and physical frailty separately. Since cognitive frailty is reversible, early intervention can delay or prevent the occurrence of cognitive frailty. Therefore, cognitive-motor dual tasks are introduced. For more information, see the effectiveness of dual-tasking in cases of cognitive decline.

Purpose: Goal is to not only explore the feasibility of a motor-cognition dual-task program for elderly individuals with cognitive frailty but also to compare its impact on cognitive and physical function with existing training programs. By doing so, the purpose of this study will be to provide practical insights that can inform the development of effective interventions for this vulnerable population.

Methods: A randomized clinical trial was used to explore the effectiveness of a dual-task intervention program on cognitive function and physical activity in older adults with cognitive frailty. Eligible subjects were recruited through convenience sampling and randomly assigned to two groups. The experimental group used Nintendo Switch to perform dual tasks of motor cognition, while the control group performed regular activities. Twice a week, 60 minutes each time, for eight weeks of training. Both groups completed basic information (demographics, disease characteristics, and lifestyle), cognitive function measurements, and physical activity function measurements in the pre-test (T0) in the 4th week (T1) and 8th week (T2). Cognitive function measurements and physical activity function measurements were performed again. Using SPSS 29.0 as a statistical tool, independent sample t-test and Chi-square test were used to detect the demographic variables, disease treatment variables, living habits, cognitive functions, and physical effects of the two groups-homogeneity of activities. A generalized estimating equation (GEE) was used as a statistical method to process and analyze repeated measurement data. The effects of the inter-group and time interaction on the two groups' cognitive function and physical activity were studied differently.

Expected research results: This study is expected to construct a suitable dual-task program to introduce the role of physical and cognitive function in this group and explore its effectiveness.

详细描述

Background:

As the population ages, the number of diseases or problems related to old adults is also increasing, among which the problem of frailty is also rising sharply. Scholars define frailty as multiple declines in physiological systems, which lead to the deterioration of body reserve functions, increase the susceptibility to clinical symptoms, and reduce The ability to cope with acute stress, leading to related complications and adverse health outcomes, such as falls, decreased physical activity, cognitive decline, and increased mortality. Scholars van Oostrom et al. classified frailty into four types: physical frailty, psychological frailty, cognitive frailty, and social frailty. They also verified that sociodemographic factors, lifestyle, and multiple diseases affect the four types of frailty . In Taiwan, most frailty research focuses on the physiological aspects. Cognitive impairment and physical frailty are common health problems in the elderly, and the relationship between the two has been widely discussed. Many studies have confirmed that physical activity can not only reduce the occurrence of cognitive impairment but also is an important factor in reducing physiological frailty. The main reason is that physical activity can stimulate endothelial function and cell molecules in series, producing a protective mechanism to fight against cognitive decline and muscle loss. However, even though frailty and cognitive impairment are linked, the two conditions are often studied separately.

In recent years, domestic and foreign scholars have begun to realize the issues related to cognitive frailty (CF) and have begun to explore its prevalence, related influencing factors, influencing results, and intervention measures. According to the literature, the prevalence of cognitive frailty has increased significantly in recent years. The prevalence of cognitive impairment among community-dwelling older adults is 9% on average, with a prevalence of 13.3% in Taiwan. This increase in data is of great significance for the adjustment of health policies, nursing, and long-term care development. Literature shows that cognitive decline is a reversible state. If pay attention to this problem and start taking relevant intervention measures, we can avoid its rapid development.

The concept and assessment of cognitive decline in the elderly have been embryonic for the past five years. Conceptual definitions have been developed abroad. In recent years, many empirical studies have been conducted, most of which focus on longitudinal studies and dual-task intervention programs to verify the effects of cognitive function and physical activity on patients with cognitive impairment, but there is still a lack of randomized controlled trials. Although there are many studies on frailty in old adults in Taiwan, most of them are still Cognitive function, and physical frailty has been studied separately, and there are few studies on the topic of cognitive frailty. Therefore, this study introduced the cognitive-motor dual task of digital technology to understand the effectiveness of the dual task in cases of cognitive impairment.

Purpose:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

Due to the nature of digital technology interventions, it is difficult to blind study caregivers and participants.

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Aged 65 years or older
  • •Subjective cognitive decline (measured by SMC with a score of at least 1 point) or mild cognitive impairment (measured by MoCA-T with a score of ≤25 points)
  • •Possessing characteristics of physiological frailty (meeting at least one of the above items as measured by FFI)

排除标准

  • •Diagnosed with Alzheimer's disease or other types of dementia
  • •Suffering from musculoskeletal diseases and severe mental illness that make it impossible to perform cognitive and motor tasks

研究组 & 干预措施

Experimental group

Experimental

The experimental group received a dual-task protocol. The intervention activities of the experimental group were cognitive and physical activity training using Nitendo Switch.

干预措施: Dual tasks of digital technology (Other)

Control group

No Intervention

The control group received usual care.

结局指标

主要结局

Taiwanese version of the Montreal Cognitive Assessment (MoCA-T)

时间窗: Eight weeks after intervention(T2=8Weeks)

This scale is used to assess the cognition funtion. The internal consistency Cronbach's coefficient of this tool is 0.83 and the test-retest reliability is 0.92.

Taiwan Odd-Even Number Sequencing Test (TOENS)

时间窗: Eight weeks after intervention(T2=8Weeks)

This scale is used to assess the cognition funtion. It's Half-reliability ranged from 0.69 to 0.95, and the test-retest reliability was 0.75.

Trail Making Test (TMT)

时间窗: Eight weeks after intervention(T2=8Weeks)

This scale is used to assess cognition function. The retest reliability of TMT-A is above 0.80 (0.60 \~0.90), and the retest reliability of TMT-B is 0.75

Taiwanese version of the Montreal Cognitive Assessment (MoCA-T)

时间窗: Baseline, pre-intervention (T0)

This scale is used to assess the cognition funtion. The internal consistency Cronbach's coefficient of this tool is 0.83 and the test-retest reliability is 0.92.

Taiwanese version of the Montreal Cognitive Assessment (MoCA-T)

时间窗: Four weeks after intervention(T1=4Weeks)

This scale is used to assess the cognition funtion. The internal consistency Cronbach's coefficient of this tool is 0.83 and the test-retest reliability is 0.92.

Taiwan Odd-Even Number Sequencing Test (TOENS)

时间窗: Baseline, pre-intervention (T0)

This scale is used to assess the cognition funtion. It's Half-reliability ranged from 0.69 to 0.95, and the test-retest reliability was 0.75.

Taiwan Odd-Even Number Sequencing Test (TOENS)

时间窗: Four weeks after intervention(T1=4Weeks)

This scale is used to assess the cognition funtion. It's Half-reliability ranged from 0.69 to 0.95, and the test-retest reliability was 0.75.

Trail Making Test (TMT)

时间窗: Baseline, pre-intervention (T0)

This scale is used to assess cognition function. The retest reliability of TMT-A is above 0.80 (0.60 \~0.90), and the retest reliability of TMT-B is 0.75

Trail Making Test (TMT)

时间窗: Four weeks after intervention(T1=4Weeks)

This scale is used to assess cognition function. The retest reliability of TMT-A is above 0.80 (0.60 \~0.90), and the retest reliability of TMT-B is 0.75

次要结局

  • Timed Up and Go (TUG)(Eight weeks after intervention)
  • Short Physical Performance Battery (SPPB)(Eight weeks after intervention)
  • Handgrip strength test(Eight weeks after intervention(T2=8Weeks))
  • Timed Up and Go (TUG)(Baseline, pre-intervention (T0))
  • Timed Up and Go (TUG)(Four weeks after intervention(T1=4Weeks))
  • Short Physical Performance Battery (SPPB)(Baseline, pre-intervention (T0))
  • Short Physical Performance Battery (SPPB)(Four weeks after intervention(T1=4Weeks))
  • Handgrip strength test(Baseline, pre-intervention (T0))
  • Handgrip strength test(Four weeks after intervention(T1=4Weeks))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chia Jung Hsieh

Ph.D., RN, Professor

National Taipei University of Nursing and Health Sciences

研究点 (1)

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