NCT06717971

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2024

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 5, 2024

Completed
Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

November 30, 2024

Last Update Submit

December 5, 2024

Conditions

Keywords

exergamemild cognitive impairmentdementialong-term care facilitiesmulticomponent training

Outcome Measures

Primary Outcomes (11)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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).

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Other: Exergame-based multicomponent training program.

Control group

SHAM COMPARATOR

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

Other: Standard care

Interventions

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.

Intervention group

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.

Control group

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, 030600, China

Location

Related Publications (9)

  • 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.

  • Yu 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.

  • Wong 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.

  • Wang 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.

  • Chu 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.

  • Chen 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.

  • Meekes 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.

  • Li 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.

  • Li 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.

MeSH Terms

Conditions

Cognitive DysfunctionDementia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 30, 2024

First Posted

December 5, 2024

Study Start

June 12, 2023

Primary Completion

June 18, 2024

Study Completion

July 11, 2024

Last Updated

December 10, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Information about the Shared Individual Participant Data (IPD) program can be obtained by contacting the registrant.

Locations