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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Recruitment rate of the exergame-assisted simultaneous motor-cognitive training (percentage) [Срок оценки: 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) [Срок оценки: From "recruiment" and "immediately after the completion" (no follow-up, intervention duration-4 weeks)]
• Adherence of the exergame-assisted simultaneous motor-cognitive training (percentage) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: From "recruiment" and "immediately after the completion" (no follow-up, intervention duration-4 weeks)]

Вторичные конечные точки (12)

• Change from baseline in "grip strength" at four weeks through grip dynamometer assessment（kilograms) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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" [Срок оценки: 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" [Срок оценки: 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" [Срок оценки: 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" [Срок оценки: From "baseline" to "immediately after the completion" (no follow-up, intervention duration-4 weeks)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

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

Публикации

• 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

Идентификаторы

NCT: NCT07085663 · HSEARS20240516005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗