Alzheimer's DiseaseNCT06717971
Utilization of Exergame Programs Among Elderly Residents in Rural Nursing Care Centers
A study testing Exergame-based multicomponent training program. in people with Alzheimer's Disease, run by Aoyu Li at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Exergame-based multicomponent training program.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 232 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2023to 11 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Alzheimer's Disease
- Being tested
- Exergame-based multicomponent training program., Standard care
- Keywords
- exergame, mild cognitive impairment, dementia, long-term care facilities, multicomponent training
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exergame-based multicomponent training program.Other
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. Each game session lasted approximately five seconds, requiring participants to quickly adapt to various physical actions and postures, such as waving, jumping, swinging arms, rotating, and mimicking object movements. The game's dynamic structure provides an engaging experience that promotes physical coordination, reaction speed, upper and lower limb strength, and hand-eye coordination through diverse movement patterns. Switching between tasks compels players to adjust to varying motion demands swiftly, enhancing physical agility while strengthening attention-shifting and quick decision-making skills.
Standard careOther
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 fitness exercises are adapted to meet the varying physical conditions of participants, ensuring a safe and comfortable environment that promotes moderate physical activity. Horticultural therapy involves hands-on planting and tending to plants, stimulating the senses, and fostering emotional regulation, contributing to improved psychological health. Sedentary activities, such as tabletop games, emphasize social interaction and cognitive maintenance by promoting a relaxed social environment that helps participants remain cognitively engaged.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention in this group is exergame-based multicomponent training program. Receives: Other: Exergame-based multicomponent training program. |
| Control group | Sham comparator | The control group received routine care in a long-term care center. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sit and Reach test
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.
Measured: 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).
Shoulder Flexibility test
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.
Measured: 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).
Trunk Rotation Flexibility test
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.
Measured: 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).
Shoulder range of motion test
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.
Measured: 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).
Elbow range of motion test
The participant stands upright, and the flexion angle of the elbow joint is measured.
Measured: 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).
Figure of eight walk test
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.
Measured: 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).
Standing balance test
The participant stands with their feet together and eyes closed to maintain balance. The duration for which the participant can maintain balance is recorded.
Measured: 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).
Box and block test
The number of blocks the participants transferred in 60 seconds from one compartment to the other compartment of the wooden box.
Measured: 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).
Cognitive abilities screening instrument
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.
Measured: 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).
Chinese version of the mini-mental state examination scale
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.
Measured: 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).
Chinese version of the montreal cognitive assessment scale
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start12 Jun 2023
- Primary completion18 Jun 2024
- Study completion11 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aoyu Li
- Sponsor type
- University, hospital or other
- Collaborators
- Shanxi Provincial People's Hospital
- Responsible party
- Sponsor-investigator, Aoyu Li, Tainan University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717971
- Sponsor's protocol ID
- TainanUT
- Other IDs
- U21A20469
- Status last verified
- Dec 2024
- First submitted
- 30 Nov 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Information about the Shared Individual Participant Data (IPD) program can be obtained by contacting the registrant.
Publications
Schattin A, Pickles J, Flagmeier D, Scharer B, Riederer Y, Niedecken S, Villiger S, Jurt R, Kind N, Scott SN, Stettler C, Martin-Niedecken AL. Development of a Novel Home-Based Exergame With On-Body Feedback: Usability Study. JMIR Serious Games. 2022 Dec 6;10(4):e38703. doi: 10.2196/38703.
PubMed 36472900Yu J, Li J, Huang X. The Beijing version of the Montreal Cognitive Assessment as a brief screening tool for mild cognitive impairment: a community-based study. BMC Psychiatry. 2012 Sep 25;12:156. doi: 10.1186/1471-244X-12-156.
PubMed 23009126Wong SS, Yam MS, Ng SS. The Figure-of-Eight Walk test: reliability and associations with stroke-specific impairments. Disabil Rehabil. 2013;35(22):1896-902. doi: 10.3109/09638288.2013.766274. Epub 2013 Apr 19.
PubMed 23600714Wang RY, Huang YC, Zhou JH, Cheng SJ, Yang YR. Effects of Exergame-Based Dual-Task Training on Executive Function and Dual-Task Performance in Community-Dwelling Older People: A Randomized-Controlled Trial. Games Health J. 2021 Oct;10(5):347-354. doi: 10.1089/g4h.2021.0057. Epub 2021 Sep 1.
PubMed 34491113Chu CH, Biss RK, Cooper L, Quan AML, Matulis H. Exergaming Platform for Older Adults Residing in Long-Term Care Homes: User-Centered Design, Development, and Usability Study. JMIR Serious Games. 2021 Mar 9;9(1):e22370. doi: 10.2196/22370.
PubMed 33687337Chen KM, Li CH, Huang HT, Cheng YY. Feasible modalities and long-term effects of elastic band exercises in nursing home older adults in wheelchairs: A cluster randomized controlled trial. Int J Nurs Stud. 2016 Mar;55:4-14. doi: 10.1016/j.ijnurstu.2015.11.004. Epub 2015 Nov 28.
PubMed 26655368Meekes W, Stanmore EK. Motivational Determinants of Exergame Participation for Older People in Assisted Living Facilities: Mixed-Methods Study. J Med Internet Res. 2017 Jul 6;19(7):e238. doi: 10.2196/jmir.6841.
PubMed 28684385Li A, Qiang W, Li J, Geng Y, Qiang Y, Zhao J. Effectiveness of an exergame-based training program on physical and cognitive function in older adults with cognitive impairment: a randomized controlled trial in rural China. BMC Geriatr. 2025 Nov 11;25(1):892. doi: 10.1186/s12877-025-06341-6.
PubMed 41219720Li A, Qiang W, Li J, Geng Y, Qiang Y, Zhao J. Retracted: Evaluating the Clinical Efficacy of an Exergame-Based Training Program for Enhancing Physical and Cognitive Functions in Older Adults With Mild Cognitive Impairment and Dementia Residing in Rural Long-Term Care Facilities: Randomized Controlled Trial. J Med Internet Res. 2025 Feb 19;27:e69109. doi: 10.2196/69109.
PubMed 39969990
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06717971
- Acronym / sponsor ID
- TainanUT
- Conditions
- Alzheimer's Disease
- Keywords
- exergame, mild cognitive impairment, dementia, long-term care facilities, multicomponent training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Aoyu LiUniversity, hospital or other
- Collaborators
- Shanxi Provincial People's Hospital
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 11 Jul 2024 (actual)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Exergame-based multicomponent training program.The intervention in this group is exergame-based multicomponent training program. |
| Control group | Sham comparator | Other: Standard careThe control group received routine care in a long-term care center. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exergame-based multicomponent training program.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. Each game session lasted approximately five seconds, requiring participants to quickly adapt to various physical actions and postures, such as waving, jumping, swinging arms, rotating, and mimicking object movements. The game's dynamic structure provides an engaging experience that promotes physical coordination, reaction speed, upper and lower limb strength, and hand-eye coordination through diverse movement patterns. Switching between tasks compels players to adjust to varying motion demands swiftly, enhancing physical agility while strengthening attention-shifting and quick decision-making skills. | Other | Intervention group |
| Standard careThe 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 fitness exercises are adapted to meet the varying physical conditions of participants, ensuring a safe and comfortable environment that promotes moderate physical activity. Horticultural therapy involves hands-on planting and tending to plants, stimulating the senses, and fostering emotional regulation, contributing to improved psychological health. Sedentary activities, such as tabletop games, emphasize social interaction and cognitive maintenance by promoting a relaxed social environment that helps participants remain cognitively engaged. | Other | Control group |
Primary outcome
Sit and Reach test
Time frame: 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
Time frame: 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.
Trunk Rotation Flexibility test
Time frame: 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.
Shoulder range of motion test
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Results publication: PubMed 36472900Schattin A, Pickles J, Flagmeier D, Scharer B, Riederer Y, Niedecken S, Villiger S, Jurt R, Kind N, Scott SN, Stettler C, Martin-Niedecken AL. Development of a Novel Home-Based Exergame With On-Body Feedback: Usability Study. JMIR Serious Games. 2022 Dec 6;10(4):e38703. doi: 10.2196/38703.
- Results publication: PubMed 23009126Yu J, Li J, Huang X. The Beijing version of the Montreal Cognitive Assessment as a brief screening tool for mild cognitive impairment: a community-based study. BMC Psychiatry. 2012 Sep 25;12:156. doi: 10.1186/1471-244X-12-156.
- Results publication: PubMed 23600714Wong SS, Yam MS, Ng SS. The Figure-of-Eight Walk test: reliability and associations with stroke-specific impairments. Disabil Rehabil. 2013;35(22):1896-902. doi: 10.3109/09638288.2013.766274. Epub 2013 Apr 19.
- Results publication: PubMed 34491113Wang RY, Huang YC, Zhou JH, Cheng SJ, Yang YR. Effects of Exergame-Based Dual-Task Training on Executive Function and Dual-Task Performance in Community-Dwelling Older People: A Randomized-Controlled Trial. Games Health J. 2021 Oct;10(5):347-354. doi: 10.1089/g4h.2021.0057. Epub 2021 Sep 1.
- Results publication: PubMed 33687337Chu CH, Biss RK, Cooper L, Quan AML, Matulis H. Exergaming Platform for Older Adults Residing in Long-Term Care Homes: User-Centered Design, Development, and Usability Study. JMIR Serious Games. 2021 Mar 9;9(1):e22370. doi: 10.2196/22370.
- Results publication: PubMed 26655368Chen KM, Li CH, Huang HT, Cheng YY. Feasible modalities and long-term effects of elastic band exercises in nursing home older adults in wheelchairs: A cluster randomized controlled trial. Int J Nurs Stud. 2016 Mar;55:4-14. doi: 10.1016/j.ijnurstu.2015.11.004. Epub 2015 Nov 28.
- Results publication: PubMed 28684385Meekes W, Stanmore EK. Motivational Determinants of Exergame Participation for Older People in Assisted Living Facilities: Mixed-Methods Study. J Med Internet Res. 2017 Jul 6;19(7):e238. doi: 10.2196/jmir.6841.
- Derived from this study: PubMed 41219720Li A, Qiang W, Li J, Geng Y, Qiang Y, Zhao J. Effectiveness of an exergame-based training program on physical and cognitive function in older adults with cognitive impairment: a randomized controlled trial in rural China. BMC Geriatr. 2025 Nov 11;25(1):892. doi: 10.1186/s12877-025-06341-6.
- Derived from this study: PubMed 39969990Li A, Qiang W, Li J, Geng Y, Qiang Y, Zhao J. Retracted: Evaluating the Clinical Efficacy of an Exergame-Based Training Program for Enhancing Physical and Cognitive Functions in Older Adults With Mild Cognitive Impairment and Dementia Residing in Rural Long-Term Care Facilities: Randomized Controlled Trial. J Med Internet Res. 2025 Feb 19;27:e69109. doi: 10.2196/69109.
- Individual participant dataSharing planned: No. Information about the Shared Individual Participant Data (IPD) program can be obtained by contacting the registrant.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergame-based multicomponent training program. in people with Alzheimer's Disease, run by Aoyu Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sit and Reach test (time frame: 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 study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06717971, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.