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临床试验/NCT06717971
NCT06717971已完成不适用

Evaluating the Clinical Effectiveness of an Exergame-Based Training Program Using "WarioWare: Move It!" to Enhance Physical and Cognitive Function in Older Adults With Mild Cognitive Impairment and Dementia in Rural Long-Term Care Facilities: A Randomized Controlled Trial

Aoyu Li1 个研究点 分布在 1 个国家目标入组 232 人开始时间: 2023年6月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
232
试验地点
1
主要终点
Trunk Rotation Flexibility test

研究概览

简要总结

Background: Cognitive impairment is prevalent among older adults and frequently misdiagnosed or diagnosed late, increasingly drawing attention as a significant health issue in aging populations. Compared to community-dwelling individuals, cognitive impairments are more common among residents of long-term care facilities (LTCFs). These facilities face challenges implementing organized exercise programs due to a shortage of professional caregivers and limited resources. Additionally, older adults may lose interest in repetitive interventions over time. "WarioWare: Move It!" by Nintendo, a novel exergame that combines aerobic exercise, body coordination, balance training, and cognitive tasks, provides an immersive experience to enhance motivation and reduce staff intervention, presenting a potential solution.

Methods: The randomized controlled trial was conducted across multiple rural LTCFs in Shanxi Province, involving participants aged 65 and older. Participants were randomly assigned to either the intervention group (receiving the "WarioWare: Move It!" intervention) or the control group (receiving standard care). The intervention involved motion-sensing actions and postures (such as waving, jumping, arm swinging, rotating, and mimicking object movements) using the Joy-Con controllers for 60 minutes twice a week over 12 weeks. Primary outcome measures were derived from a battery of clinical tests, including the Sit and Reach test (the distance between the hands and toes when reaching forward), Shoulder Flexibility test (the distance between hands clasped behind the back), Trunk Rotation Flexibility test (the angle of the waist rotation to each side), Shoulder Range of Motion test (the angles of shoulder flexion, extension, abduction, and adduction), Elbow Range of Motion test (the angle of elbow flexion), Figure-of-Eight Walk test (completion time), Standing Balance test (balance duration), Hand Dexterity test (the number of blocks moved by the dominant hand in one minute), and Cognitive Function tests (e.g., Cognitive Abilities Screening Instrument, the Chinese version of the Mini-Mental State Examination, and the Montreal Cognitive Assessment). Statistical analysis was performed using mixed ANOVA, with time as the within-subject factor and intervention group as the between-subject factor, to assess the training effects on the various outcome measures.

Anticipated benefits: The intervention involving *WarioWare: Move It!* holds promise for enhancing physical flexibility, joint mobility, motor coordination, hand dexterity, and cognitive function among elderly individuals with mild cognitive impairment or dementia residing in rural care centers. This innovative and practical approach offers a viable solution for promoting health among older adults in resource-limited settings, demonstrating significant potential for broader application in similar environments.

详细描述

Background:

Cognitive impairment is prevalent among older adults and frequently misdiagnosed or diagnosed late, increasingly drawing attention as a significant health issue in aging populations. Compared to community-dwelling individuals, cognitive impairments are more common among residents of long-term care facilities (LTCFs). These facilities face challenges implementing organized exercise programs due to a shortage of professional caregivers and limited resources. Additionally, older adults may lose interest in repetitive interventions over time.

Despite the demonstrated clinical benefits of exergames for community-dwelling older adults, their effectiveness within LTCFs remains insufficiently explored. Current research primarily focuses on improvements in health-related quality of life, cognitive function, and overall functional status, with relatively few assessments targeting specific physical functions, such as flexibility, joint mobility, motor coordination, and hand dexterity. However, these physical capabilities are crucial for the independence of older adults. For instance, limited flexibility can hinder daily activities, directly impacting self-care abilities and increasing dependency on others. A reduction in joint mobility is often associated with joint stiffness and pain, restricting the range of motion and diminishing overall physical function, limiting the living space and activity radius of elderly individuals. Motor coordination is critical in balance maintenance and complex movements, where diminished coordination heightens the risk of falls. Falls can have severe consequences for older adults, including fractures, prolonged immobility, or even accelerated frailty, substantially reducing the quality of life. Hand dexterity also underpins the self-sufficiency of older adults. Loss of fine motor skills, such as gripping, pinching, and writing, can restrict their ability to perform daily tasks and participate socially, potentially leading to psychological distress.

The Nintendo exergame "WarioWare: Move It!" integrates twelve distinct movement modes, offering not only aerobic, coordination, and balance training but also cognitive exercises that engage memory, attention, and logical reasoning. The game's difficulty can be flexibly adjusted to match users' needs, ensuring optimal training effects at appropriate challenge levels. Despite its evident potential, comprehensive empirical studies are still required to substantiate its benefits fully. Therefore, this study conducted a 12-week longitudinal user study to examine the feasibility and potential clinical utility of "WarioWare: Move It!" for elderly populations in rural LTCFs. Furthermore, this research provides valuable insights and references for geriatric rehabilitation professionals and human-computer interaction researchers interested in designing exergame-based interventions for elderly care.

Methods:

研究设计

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

盲法说明

Because of the design of the study and the nature of the interventions, blinding the staff and participants of the LTCFs is impossible. The assessors, measuring the outcomes, and the interpreter, analyzing the data, will be blinded in this study.

入排标准

年龄范围
65 Years 至 90 Years(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •normal or corrected-to-normal hearing and vision;
  • •age over 65;
  • •residence in a senior care facility or a minimum stay of one month in such a facility;
  • •completion of the Global Deterioration Scale (GDS), the Chinese version of the Mini-Mental State Examination (MMSE), and the Chinese version of the Montreal Cognitive Assessment (MoCA), with the capacity to communicate effectively;
  • •ability to engage in moderate physical activity without physical disability;
  • •absence of severe depressive symptoms or other neurological disorders (e.g., stroke, dizziness, epilepsy);
  • •provision of informed consent by the participant or their guardian.

排除标准

  • •Individuals who have significant cardiopulmonary diseases;
  • •those regularly receiving oxygen supplementation
  • •those who have uncontrollable hypertension
  • •those who had a recent infection or fracture or were diagnosed with other diseases that might prohibit them from participating in exercises according to the guidelines of the American College of Sports Medicine.

研究组 & 干预措施

Intervention group

Experimental

The intervention in this group is exergame-based multicomponent training program.

干预措施: Exergame-based multicomponent training program. (Other)

Control group

Sham Comparator

The control group received routine care in a long-term care center.

干预措施: Standard care (Other)

结局指标

主要结局

Trunk Rotation Flexibility test

时间窗: The initial assessment occurred at baseline prior to randomization. Subsequent evaluations were conducted at the end of 12 weeks (post-test) and six months after the intervention concluded (after 6 months).

The Trunk Rotation Flexibility test requires participants to stand with feet together, and arms extended forward, rotating the torso left and right around the waist. The maximum angle reached on each side indicates flexibility, with more prominent angles signifying greater flexibility.

Sit and Reach test

时间窗: The initial assessment occurred at baseline prior to randomization. Subsequent evaluations were conducted at the end of 12 weeks (post-test) and six months after the intervention concluded (after 6 months).

The Sit and Reach test measures the participant's ability to stretch forward while seated with legs extended and heels fixed. The farthest distance reached with outstretched hands toward the toes is recorded, with the gap between the fingertips and toes serving as the flexibility index.

Shoulder Flexibility test

时间窗: The initial assessment occurred at baseline prior to randomization. Subsequent evaluations were conducted at the end of 12 weeks (post-test) and six months after the intervention concluded (after 6 months).

The Shoulder Flexibility test assesses flexibility by measuring the distance between the hands when clasped behind the back \[31-32\]. Participants with higher flexibility achieve either easy hand clasping or shorter hand-to-hand distance.

Shoulder range of motion test

时间窗: The initial assessment occurred at baseline prior to randomization. Subsequent evaluations were conducted at the end of 12 weeks (post-test) and six months after the intervention concluded (after 6 months).

The participant stands upright, and the maximum range of motion of the shoulder joint is measured in the following directions: flexion, extension, abduction, and adduction.

Elbow range of motion test

时间窗: The initial assessment occurred at baseline prior to randomization. Subsequent evaluations were conducted at the end of 12 weeks (post-test) and six months after the intervention concluded (after 6 months).

The participant stands upright, and the flexion angle of the elbow joint is measured.

Figure of eight walk test

时间窗: The initial assessment occurred at baseline prior to randomization. Subsequent evaluations were conducted at the end of 12 weeks (post-test) and six months after the intervention concluded (after 6 months).

The participant walks around two markers placed on the floor in a figure-of-eight pattern, with a total walking distance of 10 meters. The time taken to complete the walk is recorded.

Standing balance test

时间窗: The initial assessment occurred at baseline prior to randomization. Subsequent evaluations were conducted at the end of 12 weeks (post-test) and six months after the intervention concluded (after 6 months).

The participant stands with their feet together and eyes closed to maintain balance. The duration for which the participant can maintain balance is recorded.

Box and block test

时间窗: The initial assessment occurred at baseline prior to randomization. Subsequent evaluations were conducted at the end of 12 weeks (post-test) and six months after the intervention concluded (after 6 months).

The number of blocks the participants transferred in 60 seconds from one compartment to the other compartment of the wooden box.

Cognitive abilities screening instrument

时间窗: The initial assessment occurred at baseline prior to randomization. Subsequent evaluations were conducted at the end of 12 weeks (post-test) and six months after the intervention concluded (after 6 months).

The scale is commonly used to assess mild cognitive impairment and early-stage dementia, comprising nine sections that evaluate domains such as attention, memory, orientation, language, abstract thinking, and calculation. The assessment typically takes 20 minutes to complete. Scores range from 0 to 100, with higher scores indicating better cognitive function.

Chinese version of the mini-mental state examination scale

时间窗: The initial assessment occurred at baseline prior to randomization. Subsequent evaluations were conducted at the end of 12 weeks (post-test) and six months after the intervention concluded (after 6 months).

The scale is widely used in clinical and research settings to evaluate cognitive status through a brief question-and-answer format. It covers dimensions such as orientation, memory, attention, language skills, and visuospatial abilities. The scoring range is 0 to 30, with higher scores indicating superior cognitive performance.

Chinese version of the montreal cognitive assessment scale

时间窗: The initial assessment occurred at baseline prior to randomization. Subsequent evaluations were conducted at the end of 12 weeks (post-test) and six months after the intervention concluded (after 6 months).

The scale is a comprehensive assessment tool for cognitive performance across multiple domains. It consists of 30 items and evaluates visuospatial abilities, memory, language, calculation, abstract reasoning, attention, and orientation. The test typically takes around 10 minutes to administer. Scores range from 0 to 30, with higher scores correlating with better cognitive function.

次要结局

未报告次要终点

研究者

发起方
Aoyu Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Aoyu Li

Clinical Professor

Tainan University of Technology

研究点 (1)

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