Exergame-assisted Simultaneous Motor-cognitive Training for Middle-aged Old Adults in China

Official title

Exergame-assisted Simultaneous Motor-cognitive Training for Middle-aged Old Adults in China: a Feasibility and Pilot Randomized Controlled Trail Study

Overview

To develop and conduct a pilot trial on the effectiveness of a technology-based (exergame) intervention approach for the middle-aged old adults' population in China. The study will examine the feasibility of the intervention and estimate its preliminary effects in improving their physical, cognitive, and dual-task performance.

Interventions

• Other Exergame-assisted simultaneous motor-cognitive training
  Exergame-assisted simultaneous motor-cognitive training

Primary outcome measures

• Recruitment rate of the exergame-assisted simultaneous motor-cognitive training (percentage) [Time frame: From "recruiment" and "immediately after the completion" (no follow-up, intervention duration-4 weeks)]
• Retention rate of the exergame-assisted simultaneous motor-cognitive training (percentage) [Time frame: From "recruiment" and "immediately after the completion" (no follow-up, intervention duration-4 weeks)]
• Adherence of the exergame-assisted simultaneous motor-cognitive training (percentage) [Time frame: From "recruiment" and "immediately after the completion" (no follow-up, intervention duration-4 weeks)]
• Acceptability of the exergame-assisted simultaneous motor-cognitive training (narrative description) [Time frame: From "recruiment" and "immediately after the completion" (no follow-up, intervention duration-4 weeks)]
• Adverse events of the exergame-assisted simultaneous motor-cognitive training (narrative description) [Time frame: From "recruiment" and "immediately after the completion" (no follow-up, intervention duration-4 weeks)]

Secondary outcome measures (12)

• Change from baseline in "grip strength" at four weeks through grip dynamometer assessment（kilograms) [Time frame: From "baseline" to "immediately after the completion" (no follow-up, intervention duration-4 weeks)]
• Change from baseline in "lower limb muscle strength and functional muscle endurance" at four weeks through "30-second chair stand"(frequency) [Time frame: From "baseline" to "immediately after the completion" (no follow-up, intervention duration-4 weeks)]
• Change from baseline in "lower limb muscle strength and functional muscle endurance" at four weeks through "30- second deep squat elastic band"(frequency) [Time frame: From "baseline" to "immediately after the completion" (no follow-up, intervention duration-4 weeks)]
• Change from baseline in "the ability to extend the trunk, hip joints, and posterior muscle groups of the lower limbs and the range of motion of the joints" at four weeks through "seated forward bending"(centimeters) [Time frame: From "baseline" to "immediately after the completion" (no follow-up, intervention duration-4 weeks)]
• Change from baseline in "dynamic balance ability and postural control stability" at four weeks through "functional reach test, FRT"(centimeters) [Time frame: From "baseline" to "immediately after the completion" (no follow-up, intervention duration-4 weeks)]
• Change from baseline in "exercise endurance test" at four weeks through "6-minute walk test, 6MWT" (meters) [Time frame: From "baseline" to "immediately after the completion" (no follow-up, intervention duration-4 weeks)]
• Change from baseline in "functional mobility" at four weeks through "timed up and go,TUG" (seconds) [Time frame: From "baseline" to "immediately after the completion" (no follow-up, intervention duration-4 weeks)]
• Change from baseline in "static balance ability" at four weeks through "one-legged standing, OLS" (seconds) [Time frame: From "baseline" to "immediately after the completion" (no follow-up, intervention duration-4 weeks)]
• Change from baseline in "cognitive function" at four weeks through scale(total score) by "the Montreal Cognitive Assessment" [Time frame: From "baseline" to "immediately after the completion" (no follow-up, intervention duration-4 weeks)]
• Change from baseline in "cognitive function" at four weeks through scale(total score) by "the Subjective Cognitive Decline-9" [Time frame: From "baseline" to "immediately after the completion" (no follow-up, intervention duration-4 weeks)]
• Change from baseline in "cognitive function and dual-task performance" at four weeks through scales(total score and seconds taken to answer per question) by "the COGNITIVE EXPERIMENTS STANDARD TOOLBOX" [Time frame: From "baseline" to "immediately after the completion" (no follow-up, intervention duration-4 weeks)]
• Change from baseline in "cognitive function and dual-task performance" at four weeks through scales(total score and seconds taken to answer per question) by "the automatic scoring and timing in the exergame" [Time frame: From "baseline" to "immediately after the completion" (no follow-up, intervention duration-4 weeks)]

Eligibility criteria

Inclusion criteria

• people between 50 and 60 years of age
• living in mainland China
• confirmed subjective cognitive decline with the following diagnostic criteria; a confirmed case of subjective cognitive decline that meets the subjective cognitive decline-9 scale and an exclusion of mild cognitive impairment cases using the Montreal Cognitive Assessment scale to rule out mild cognitive impairment; subjective decline in memory rather than other cognitive domains; episodes of subjective cognitive decline within the past 5 years; participants perceived to experience a sustained decline in cognitive performance compared to previous normality, independent of an acute event.
• the absence of a medical condition that renders exercise inappropriate. This includes, but is not limited to, heart disease, hypertension, diabetes, respiratory disease (e.g., chronic obstructive pulmonary disease), joint and bone disease, and neurological disease (e.g., parkinson's disease)
• have the ability to perform independent activities of daily living (as measured by the independent activities of daily living scale)
• have no history of falls
• have no language barriers and have adequate communication skills

Exclusion criteria

• active mental disorder, serious mental illness, neurological disorder, or cognitive impairment (standard mild cognitive impairment, prodromal Alzheimer's disease or dementia, or other significant cognitive deficits)
• substance use for a long-term mental or neurological illness
• severe mobility or sensory impairments that may prevent participation in research activities
• unstable or acute medical conditions
• individuals who have recently undergone major surgery or have acute orthopedic conditions
• individuals who refuse to participate

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Sichuan Tianfu New District Huayang Street Helin Community Cognitive Care Center — Chengdu

Publications

• Li Y, Liu Y, Leung AY, Montayre J. Technology-Assisted Motor-Cognitive Training Among Older Adults: Rapid Systematic Review of Randomized Controlled Trials. JMIR Serious Games. 2025 Jun 3;13:e67250. doi: 10.2196/67250. PMID 40460432

Identifiers

NCT: NCT07085663 · HSEARS20240516005

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗