Clinical trial NCT06717971: Utilization of Exergame Programs Among Elderly Residents in Rural Nursing Care Centers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer&#39;s Disease
Keywords: exergame
mild cognitive impairment
dementia
long-term care facilities
multicomponent training
Lead sponsor: Tainan University of Technology
Sponsor class: OTHER
Collaborators: name: Shanxi Provincial People's Hospital
First posted: 2024-12-05
Enrollment: 232
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The training program for the intervention group utilized the Nintendo Switch game "WarioWare: Move It,". Participants engaged with the game through Joy-Con controllers, completing rapid micro-games designed to meet specific movement-oriented objectives. The "WarioWare: Move It" training program was administered twice weekly, with each session lasting 60 minutes over 12 weeks. Each session comprised three 10-minute gaming segments, interspersed with rest periods of 1 to 5 minutes to sustain participant engagement and mitigate mental fatigue. The standard care program for the control group is grounded in routine practices of long-term care facilities, aiming to sustain and enhance the physical and mental well-being of elderly residents through structured group activities. These activities encompass tailored fitness exercises, horticultural therapy, and sedentary group engagements for older adults. The program is conducted twice a week, with each session lasting 60 minutes over 12 weeks.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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:

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.

Study Procedure:

Participants meeting the inclusion criteria will be recruited from long-term care facilities in Shanxi Province, including daycare centers and nursing homes. A purposive sampling method will be employed for participant selection, with the entire recruitment process strictly supervised by experienced neurologists.

Participants will be randomly assigned to either the intervention group or the control group.

All outcome measures will be assessed at baseline, after 12 weeks of intervention, and 6 months post-intervention.

Eligibility criteria: Inclusion Criteria:

1. normal or corrected-to-normal hearing and vision;
2. age over 65;
3. residence in a senior care facility or a minimum stay of one month in such a facility;
4. 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;
5. ability to engage in moderate physical activity without physical disability;
6. absence of severe depressive symptoms or other neurological disorders (e.g., stroke, dizziness, epilepsy);
7. provision of informed consent by the participant or their guardian.

Exclusion Criteria:

1. Individuals who have significant cardiopulmonary diseases;
2. those regularly receiving oxygen supplementation
3. those who have uncontrollable hypertension
4. 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.

Primary outcomes:
measure: Sit and Reach test
timeFrame: 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).
measure: Shoulder Flexibility test
timeFrame: 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).
measure: Trunk Rotation Flexibility test
timeFrame: 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).
measure: Shoulder range of motion test
timeFrame: 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).
measure: Elbow range of motion test
timeFrame: 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).
measure: Figure of eight walk test
timeFrame: 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).
measure: Standing balance test
timeFrame: 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).
measure: Box and block test
timeFrame: 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).
measure: Cognitive abilities screening instrument
timeFrame: 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).
measure: Chinese version of the mini-mental state examination scale
timeFrame: 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).
measure: Chinese version of the montreal cognitive assessment scale
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Taiyuan
country: China
facility: Shanxi Provincial People's Hospital
state: Shanxi
Study officials:
References:
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