Manser Patrick, Michels Lars, Schmidt André, Barinka Filip, de Bruin Eling D
Motor Control and Learning Group - Institute of Human Movement Sciences and Sport, Department of Health Sciences and Technology, ETH Zurich, Zurich, Switzerland.
Department of Neuroradiology, University Hospital Zurich, Zurich, Switzerland.
JMIR Res Protoc. 2023 Feb 6;12:e41173. doi: 10.2196/41173.
Simultaneous motor-cognitive training is considered promising for preventing the decline in cognitive functioning in older adults with mild neurocognitive disorder (mNCD) and can be highly motivating when applied in the form of exergaming. The literature points to opportunities for improvement in the application of exergames in individuals with mNCD by developing novel exergames and exergame-based training concepts that are specifically tailored to patients with mNCD and ensuring the implementation of effective training components.
This study systematically explores the effectiveness of a newly developed exergame-based motor-cognitive training concept (called "Brain-IT") targeted to improve cognitive functioning in older adults with mNCD.
A 2-arm, parallel-group, single-blinded randomized controlled trial with a 1:1 allocation ratio (ie, intervention: control), including 34 to 40 older adults with mNCD will be conducted between May 2022 and December 2023. The control group will proceed with the usual care provided by the (memory) clinics where the patients are recruited. The intervention group will perform a 12-week training intervention according to the "Brain-IT" training concept, in addition to usual care. Global cognitive functioning will be assessed as the primary outcome. As secondary outcomes, domain-specific cognitive functioning, brain structure and function, spatiotemporal parameters of gait, instrumental activities of daily living, psychosocial factors, and resting cardiac vagal modulation will be assessed. Pre- and postintervention measurements will take place within 2 weeks before starting and after completing the intervention. A 2-way analysis of covariance or the Quade nonparametric analysis of covariance will be computed for all primary and secondary outcomes, with the premeasurement value as a covariate for the predicting group factor and the postmeasurement value as the outcome variable. To determine whether the effects are substantive, partial eta-squared (η) effect sizes will be calculated for all primary and secondary outcomes.
Upon the initial submission of this study protocol, 13 patients were contacted by the study team. Four patients were included in the study, 2 were excluded because they were not eligible, and 7 were being informed about the study in detail. Of the 4 included patients, 2 already completed all premeasurements and were in week 2 of the intervention period. Data collection is expected to be completed by December 2023. A manuscript of the results will be submitted for publication in a peer-reviewed open-access journal in 2024.
This study contributes to the evidence base in the highly relevant area of preventing disability because of cognitive impairment, which has been declared a public health priority by the World Health Organization.
ClinicalTrials.gov NCT05387057; https://clinicaltrials.gov/ct2/show/NCT05387057.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41173.
同时进行运动与认知训练被认为在预防轻度神经认知障碍（mNCD）老年人的认知功能衰退方面颇具前景，且以运动游戏形式应用时能极大地激发积极性。文献指出，通过开发专门针对mNCD患者的新型运动游戏及基于运动游戏的训练概念，并确保有效训练组件的实施，在mNCD个体中应用运动游戏存在改进空间。
本研究系统地探索一种新开发的基于运动游戏的运动 - 认知训练概念（称为“Brain - IT”）对改善mNCD老年人认知功能的有效性。
将在2022年5月至2023年12月期间进行一项双臂、平行组、单盲随机对照试验，分配比例为1:1（即干预组：对照组），纳入34至40名患有mNCD的老年人。对照组将接受招募患者的（记忆）诊所提供的常规护理。干预组除常规护理外，将根据“Brain - IT”训练概念进行为期12周的训练干预。将整体认知功能评估作为主要结局。作为次要结局，将评估特定领域的认知功能、脑结构与功能、步态的时空参数、日常生活工具性活动、心理社会因素以及静息时心脏迷走神经调制。干预前和干预后的测量将在开始干预前2周内及完成干预后进行。将针对所有主要和次要结局计算双向协方差分析或Quade非参数协方差分析，将测量前的值作为预测组因素的协变量，测量后的值作为结局变量。为确定效果是否显著，将为所有主要和次要结局计算偏 eta 平方（η）效应大小。
在最初提交本研究方案时，研究团队联系了13名患者。4名患者被纳入研究，2名因不符合条件被排除，7名正在详细了解该研究。在纳入的4名患者中，2名已完成所有测量前评估，处于干预期的第2周。预计数据收集将于2023年12月完成。研究结果的手稿将于2024年提交至同行评审的开放获取期刊发表。
本研究为预防因认知障碍导致的残疾这一高度相关领域的证据基础做出了贡献，认知障碍已被世界卫生组织宣布为公共卫生重点。
ClinicalTrials.gov NCT05387057；https://clinicaltrials.gov/ct2/show/NCT05387057。
国际注册报告识别码（IRRID）：DERR
