Exergame-assisted Simultaneous Motor-cognitive Training for Middle-aged Old Adults in China: a Feasibility and Pilot Randomized Controlled Trail Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recruitment rate of the exergame-assisted simultaneous motor-cognitive training (percentage)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Recruitment rate of the exergame-assisted simultaneous motor-cognitive training (percentage)
时间窗: From "recruiment" and "immediately after the completion" (no follow-up, intervention duration-4 weeks)
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.
Retention rate of the exergame-assisted simultaneous motor-cognitive training (percentage)
时间窗: From "recruiment" and "immediately after the completion" (no follow-up, intervention duration-4 weeks)
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.
Adherence of the exergame-assisted simultaneous motor-cognitive training (percentage)
时间窗: From "recruiment" and "immediately after the completion" (no follow-up, intervention duration-4 weeks)
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.
Acceptability of the exergame-assisted simultaneous motor-cognitive training (narrative description)
时间窗: From "recruiment" and "immediately after the completion" (no follow-up, intervention duration-4 weeks)
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.
Adverse events of the exergame-assisted simultaneous motor-cognitive training (narrative description)
时间窗: From "recruiment" and "immediately after the completion" (no follow-up, intervention duration-4 weeks)
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
次要结局
- 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))
- Change from baseline in "exercise endurance test" at four weeks through "6-minute walk test, 6MWT" (meters)(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)(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)(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"(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"(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"(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"(From "baseline" to "immediately after the completion" (no follow-up, intervention duration-4 weeks))
研究者
LI Yaqin
Principal Investigator
The Hong Kong Polytechnic University