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

NCT07085663 | Recruiting

• 1 other identifier: HSEARS20240516005
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Subjective Cognitive Decline

Keywords

exergame; subjective cognitive decline; middle-aged; physical performance; cognitive performance; dual-task performance

Outcome Measures

Primary Outcomes (5)

• Recruitment rate of the exergame-assisted simultaneous motor-cognitive training (percentage)

  Recruitment rate = (number of successful applicants ÷ total number of potential applicants) × 100%. The higher the percentage, the better the recruitment efficiency.The recruitment rate is calculated after the experiment ends, with all potential participants and successful participants recorded throughout the process.

  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)

  Retention rate = (number of participants still employed at the end of the experiment ÷ number of participants employed at the beginning of the experiment) × 100%. The higher the ratio, the better feasibility.The retention rate is calculated after the experiment ends, with recording of all participants still employed and participants employed at the beginning of the experiment throughout the whole process.

  From "recruiment" and "immediately after the completion" (no follow-up, intervention duration-4 weeks)

• Adherence of the exergame-assisted simultaneous motor-cognitive training (percentage)

  Adherence = (actual number of interventions completed ÷ total number of planned interventions) × 100%. Adherence ≥80% indicates good intervention feasibility (supporting formal RCT implementation), \<70% suggests that the programme needs to be optimised (e.g. adjusting intensity, frequency or support measures), and if the adherence rate for key steps (e.g. medication) is \<50%, this may affect the validity assessment.

  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)

  The acceptability of this study will be evaluated by recording participants' evaluations of the experiment and positive/neutral/negative descriptions using a dedicated form. The more positive descriptions there will be, the better the acceptability.

  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)

  The adverse events of this study will be recorded using a dedicated form (time, location, first aid treatment, causal analysis, follow-up). Adverse events are recorded throughout the entire experimental process. The less adverse events descriptions there will be, the better the feasibility

  From "recruiment" and "immediately after the completion" (no follow-up, intervention duration-4 weeks)

Secondary Outcomes (12)

• Change from baseline in "grip strength" at four weeks through grip dynamometer assessment（kilograms)

  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)

  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)

  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)

  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)

  From "baseline" to "immediately after the completion" (no follow-up, intervention duration-4 weeks)

Study Arms (2)

Exergame-assisted motor-cognitive training group

EXPERIMENTAL

Exergame-assisted motor-cognitive training group

Other: Exergame-assisted simultaneous motor-cognitive training

Blank control

NO INTERVENTION

Blank control

Interventions

Exergame-assisted simultaneous motor-cognitive training OTHER

Exergame-assisted simultaneous motor-cognitive training

Exergame-assisted motor-cognitive training group

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• people between 50 and 60 years of age
• living in mainland China
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

Sichuan Tianfu New District Huayang Street Helin Community Cognitive Care Center

Chengdu, Sichuan, 61000, China

RECRUITING

Related Publications (1)

• 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 BACKGROUND

Central Study Contacts

Yaqin Li

CONTACT

+86 18502853115; yaqinli0809@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: July 25, 2025
• Study Start: May 20, 2025
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)