Department of Old Age Psychiatry and Psychotic Disorders, Medical University of Lodz, Lodz, Poland.
Department of Clinical Pharmacology, Medical University of Lodz, Lodz, Poland.
JMIR Res Protoc. 2024 Jun 5;13:e53261. doi: 10.2196/53261.
BACKGROUND: Virtual reality (VR) has emerged as a promising technology for enhancing the health care of older individuals, particularly in the domains of cognition, physical activity, and social engagement. However, existing VR products and services have limited availability and affordability; hence, there is a need for a scientifically validated and personalized VR service to be used by older adults in their homes, which can improve their overall physical, cognitive, and social well-being. OBJECTIVE: The main purpose of the CoSoPhy FX (Cognitive, Social, and Physical Effects) study was to analyze the effects of a VR-based digital therapeutics app on the cognitive, social, and physical performance abilities of healthy (high-functioning) older adults. This paper presents the study protocol and the results from the recruitment phase. METHODS: A group of 188 healthy older adults aged 65-85 years, recruited at the Medical University of Lodz, Poland, were randomly allocated to the experimental group (VR dual-task training program) or to the control group (using a VR headset app showing nature videos). A total of 3 cognitive exercises were performed in various 360° nature environments delivered via a VR head-mounted display; the participants listened to their preferred music genre. Each patient received 3 sessions of 12 minutes per week for 12 weeks, totaling a minimum of 36 sessions per participant. Attention and working memory (Central Nervous System Vital Signs computerized cognitive battery) were used as primary outcomes, while other cognitive domains in the Central Nervous System Vital Signs battery, quality of life (World Health Organization-5 Well-Being Index), health-related quality of life (EQ-5D-5L), and anxiety (General Anxiety Disorder 7-item questionnaire) were the secondary outcomes. The group-by-time interaction was determined using linear mixed models with participants' individual slopes. RESULTS: In total, 122 (39%) of the initial 310 participants failed to meet the inclusion criteria, resulting in a recruitment rate of 61% (188/310). Among the participants, 68 successfully completed the intervention and 62 completed the control treatment. The data are currently being analyzed, and we plan to publish the results by the end of September 2024. CONCLUSIONS: VR interventions have significant potential among healthy older individuals. VR can address various aspects of well-being by stimulating cognitive functions, promoting physical activity, and facilitating social interaction. However, challenges such as physical discomfort, technology acceptance, safety concerns, and cost must be considered when implementing them for older adults. Further research is needed to determine the long-term effects of VR-based interventions, optimal intervention designs, and the specific populations that would benefit most. TRIAL REGISTRATION: ClinicalTrials.gov NCT05369897; https://clinicaltrials.gov/study/NCT05369897. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/53261.
背景:虚拟现实 (VR) 已成为增强老年人医疗保健的有前途的技术,特别是在认知、身体活动和社交参与领域。然而,现有的 VR 产品和服务可用性和可负担性有限;因此,需要一种经过科学验证和个性化的 VR 服务,供老年人在自己家中使用,以提高他们的整体身体、认知和社交幸福感。
目的:CoSoPhy FX(认知、社交和身体影响)研究的主要目的是分析基于 VR 的数字治疗应用程序对健康(高功能)老年人认知、社交和身体表现能力的影响。本文介绍了研究方案和招募阶段的结果。
方法:在波兰罗兹医科大学招募了 188 名年龄在 65-85 岁的健康老年人,他们被随机分配到实验组(VR 双重任务训练计划)或对照组(使用显示自然视频的 VR 头戴式设备)。参与者在各种 360°自然环境中进行了 3 项认知练习,通过 VR 头戴式显示器进行;他们听自己喜欢的音乐类型。每位患者每周接受 3 次 12 分钟的治疗,共 12 周,每位患者至少接受 36 次治疗。注意力和工作记忆(中枢神经系统生命体征计算机认知电池)被用作主要结果,而中枢神经系统生命体征电池中的其他认知领域、生活质量(世界卫生组织-5 项幸福感指数)、健康相关生活质量(EQ-5D-5L)和焦虑(一般焦虑症 7 项问卷)则是次要结果。使用线性混合模型确定组间时间交互作用,考虑参与者的个体斜率。
结果:在最初的 310 名参与者中,共有 122 名(39%)不符合纳入标准,因此招募率为 61%(188/310)。其中,68 名参与者成功完成了干预,62 名完成了对照组治疗。目前正在分析数据,我们计划在 2024 年 9 月底之前发布结果。
结论:VR 干预措施对健康老年人具有重要潜力。VR 可以通过刺激认知功能、促进身体活动和促进社交互动来满足各种幸福感需求。然而,在为老年人实施 VR 时,必须考虑身体不适、技术接受度、安全问题和成本等挑战。需要进一步研究以确定基于 VR 的干预措施的长期效果、最佳干预设计以及最受益的特定人群。
试验注册:ClinicalTrials.gov NCT05369897;https://clinicaltrials.gov/study/NCT05369897。
国际注册报告标识符(IRRID):DERR1-10.2196/53261。
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