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Subjective Cognitive DeclineNCT07085663

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

A study testing Exergame-assisted simultaneous motor-cognitive training in people with Subjective Cognitive Decline, run by The Hong Kong Polytechnic University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 to 60 years
Conditions the study is for
Subjective Cognitive Decline
What is being tested?
Exergame-assisted simultaneous motor-cognitive training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
20 May 2025to 30 Aug 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 50 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Sichuan Tianfu New District Huayang Street Helin Community Cognitive Care Center

    Chengdu, Sichuan, 61000

    yaqin li, +86 18502853115, yaqinli0809@gmail.com

    Recruiting

Other trials in China

About this study

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

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.

Being tested
Exergame-assisted simultaneous motor-cognitive training
Keywords
exergame, subjective cognitive decline, middle-aged, physical performance, cognitive performance, dual-task performance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exergame-assisted simultaneous motor-cognitive trainingOther

    Exergame-assisted simultaneous motor-cognitive training

Study groups in NCT07085663
Study groupRoleWhat they receive
Exergame-assisted motor-cognitive training groupExperimentalExergame-assisted motor-cognitive training group
Receives: Other: Exergame-assisted simultaneous motor-cognitive training
Blank controlNo interventionBlank control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

  5. 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

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

Secondary outcomes (12)
  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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

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

  5. Change from baseline in "dynamic balance ability and postural control stability" at four weeks through "functional reach test, FRT"(centimeters)

    Participant stands upright with one arm extended forward. Without moving the feet, the maximum horizontal distance that the fingertips can be extended forward is measured (unit: centimetres). The distance value reflects dynamic balance ability. A forward extension distance of <15.2 cm indicates a significantly increased risk of falling (sensitivity 89%, specificity 79%), while healthy elderly people typically have a distance of ≥25 cm.Two assessment points, from "baseline" to "immediately after the completion" (no follow-up, intervention duration-4 weeks)

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

  6. Change from baseline in "exercise endurance test" at four weeks through "6-minute walk test, 6MWT" (meters)

    Participants walked back and forth at their fastest pace on a 30-metre flat corridor for 6 minutes. The operator reported the time every minute and provided standardised encouragement (e.g., 'Keep going, only X minutes left'). Total walking distance (metres) directly reflects cardiopulmonary function and overall endurance. Healthy adults typically achieve 400-700 metres; a distance of <300 metres suggests severe heart failure or significantly increased risk of falls, while an increase of ≥70 metres indicates effective rehabilitation therapy.Two assessment points, from "baseline" to "immediately after the completion" (no follow-up, intervention duration-4 weeks)

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

  7. Change from baseline in "functional mobility" at four weeks through "timed up and go,TUG" (seconds)

    Participants stand up from a chair with armrests, walk 3 metres at their usual pace, turn around, and return to sit down again. The entire process is timed (in seconds), and the use of conventional walking aids is permitted. The completion time directly reflects dynamic balance and fall risk. A time of ≥12 seconds indicates a significantly increased risk of falling (community elderly threshold value). Specific thresholds should be adjusted based on the population (e.g., ≥11.5 seconds for Parkinson's disease patients, ≥10 seconds for hip arthritis patients).Two assessment points, from "baseline" to "immediately after the completion" (no follow-up, intervention duration-4 weeks)

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

  8. Change from baseline in "static balance ability" at four weeks through "one-legged standing, OLS" (seconds)

    Participants stand on one leg with their eyes open (they may choose to place their hands on their hips or let them hang naturally), with the other leg bent and lifted off the ground. The maximum time spent maintaining balance is recorded (in seconds). The testing process must be conducted with full fall prevention measures in place. Standing time reflects static balance ability. Healthy adults typically achieve ≥30 seconds (for the 30-year-old population), while <10 seconds indicates a significantly increased risk of falls (a sensitive indicator for the elderly). Specific results should be interpreted in conjunction with age-specific standards (e.g., ≥15 seconds is considered normal for those aged 60 years). Two assessment points, from "baseline" to "immediately after the completion" (no follow-up, intervention duration-4 weeks)

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

  9. Change from baseline in "cognitive function" at four weeks through scale(total score) by "the Montreal Cognitive Assessment"

    Participants completed multiple cognitive domain tests included in this scale (including memory, visuospatial, executive function, attention, language, etc.), covering tasks such as alternating line drawing, cube copying, clock drawing, word recall, calculation, and orientation. The total score of the scale is 30 points. A score of ≥26 points (or ≥25 points after adjustment) indicates normal cognitive function, while a score of ≤22 points suggests mild cognitive impairment (MCI). Two assessment points, from "baseline" to "immediately after the completion" (no follow-up, intervention duration-4 weeks)

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

  10. Change from baseline in "cognitive function" at four weeks through scale(total score) by "the Subjective Cognitive Decline-9"

    Participants answered nine questions about the frequency of recent declines in memory using a self-report questionnaire. Each question was scored using a two-category option (yes = 1 point, no = 0 points) or a three-category option (often = 1 point, occasionally = 0.5 points, never = 0 points). A higher total score indicates more significant subjective cognitive decline, and participants with a total score of ≥5 were identified as having subjective cognitive decline.Two assessment points, from "baseline" to "immediately after the completion" (no follow-up, intervention duration-4 weeks)

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

  11. 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"

    "The COGNITIVE EXPERIMENTS STANDARD TOOLBOX" is an online cognitive testing platform. Users load standardised cognitive testing tasks (such as executive function, working memory, etc.) via the online platform or local programme and complete an adaptive experimental process (including practice and formal testing) according to the on-screen prompts. The system automatically generates cognitive ability scores based on comprehensive indicators such as accuracy and reaction time. Two assessment points, from "baseline" to "immediately after the completion" (no follow-up, intervention duration-4 weeks)

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

  12. 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"

    The exergame developed for this study (a total of eight sections, each divided into beginner and advanced games) are designed to train participants' various cognitive functions (including memory, attention, and executive function). The games automatically record participants' response times and scores for each section. The total score for each section (beginner or advanced) ranges from 0 to 50 points, with higher scores being better.Two assessment points, from "baseline" to "immediately after the completion" (no follow-up, intervention duration-4 weeks)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2025
  2. Study start20 May 2025
  3. Primary completion30 Aug 2025 (estimated)
  4. Study completion30 Aug 2025 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07085663
Sponsor's protocol ID
HSEARS20240516005
Status last verified
Jul 2025
First submitted
8 May 2025
Last updated
25 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 40460432

Questions about this trial

What is this clinical trial studying?

A study testing Exergame-assisted simultaneous motor-cognitive training in people with Subjective Cognitive Decline, run by The Hong Kong Polytechnic University 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 6 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: looking for participants now, as of the sponsor's last update on 25 Jul 2025. 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. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yaqin Li (+86 18502853115, yaqinli0809@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 5 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 NCT07085663, which also lists 1 linked publication.

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 25 Jul 2025.

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