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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-60
SponsorThe Hong Kong Polytechnic University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exergame-assisted simultaneous motor-cognitive training

    Other intervention

    Exergame-assisted simultaneous motor-cognitive training

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Exergame-assisted motor-cognitive training groupExperimental treatment 1 intervention
Group B: Blank controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From "recruiment" and "immediately after the completion" (no follow-up, intervention duration-4 weeks)
2

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.

Time frame
From "recruiment" and "immediately after the completion" (no follow-up, intervention duration-4 weeks)
3

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.

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

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.

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

Secondary outcomes

1

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

When measuring with an electronic dynamometer, the value may range from 0 (worst result) to any possible positive value (best result). Two assessment points, from "baseline" to "immediately after the completion" (no follow-up, intervention duration-4 weeks)

Time frame
From "baseline" to "immediately after the completion" (no follow-up, intervention duration-4 weeks)
2

Change from baseline in "lower limb muscle strength and functional muscle endurance" at four weeks through "30-second chair stand"(frequency)

Participants crossed their arms across their chest and performed the complete movement of 'fully lifting their back off the chair back → standing straight → sitting back down' as many times as possible within 30 seconds. The counting standard was that the next standing movement could only begin after the buttocks made contact with the chair seat. The assessment criteria are as follows for the 50-59 age group: males (poor: \<15 times, moderate: 15-20 times, good: \>20 times); for females (poor: \<13 times, moderate: 13-18 times, good: \>18 times). Two assessment points, from "baseline" to "immediately after the completion" (no follow-up, intervention duration-4 weeks)

Time frame
From "baseline" to "immediately after the completion" (no follow-up, intervention duration-4 weeks)
3

Change from baseline in "lower limb muscle strength and functional muscle endurance" at four weeks through "30- second deep squat elastic band"(frequency)

Participants stand with both feet on the middle section of the resistance band (the stength of resistance band is 20 pounds in this study), holding the band with both hands and securing it at shoulder level. Within 30 seconds, they perform as many full-range squats as possible (with thighs below the horizontal line), maintaining a straight back and knees aligned with the toes throughout the movement. The number of repetitions directly reflects lower limb muscle strength and dynamic stability, with a higher number indicating stronger functional strength. For individuals aged 50 to 60, males with fewer than 10 repetitions are considered weak, 10-14 repetitions are moderate, and 15 or more are strong; females with fewer than 8 repetitions are considered weak, 8-12 repetitions are moderate, and 13 or more are strong.Two assessment points, from "baseline" to "immediately after the completion" (no follow-up, intervention duration-4 weeks)

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

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)

Participants sit on the ground with legs straightened and heels together against the test box. Arms are extended forward, and the slider is slowly pushed to the farthest distance and held for 1 second. The position reached by the fingertips is measured (the sole of the foot is 0 points; values exceeding this are positive, and values not exceeding it are negative). The measurement value (in centimetres) reflects the flexibility of the lower back and hamstrings. A higher positive value indicates better flexibility (e.g., \>+15 cm is excellent), while a negative value suggests stiffness and the need for stretching (e.g., \<-5 cm indicates a risk of strain).Two assessment points, from "baseline" to "immediately after the completion" (no follow-up, intervention duration-4 weeks)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.