Virtual Reality Training for Cognitive Impairment in Adults Treated With Hemodialysis: A Feasibility Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Proportion of adverse events
研究概览
简要总结
The goal of this randomized feasibility clinical trial is to identify participant recruitment and retention, acceptability, and adherence to virtual reality training in people undergoing hemodialysis. The main question it aims to answer is if virtual reality could be a feasible and acceptable intervention in this setting.
The investigators will compare participants on virtual reality training during the standard dialysis session with those treated with standard dialysis session alone to see if a cognitive training using immersive virtual reality in people on hemodialysis is feasible and acceptable.
Participants randomised in the intervention group will use virtual reality during the standard dialysis session for 30 minutes, three times a week for 12 weeks. The virtual reality intervention will consist of computerized cognitive training of 4 games. Each exercise delivered to the participant will specifically provide training in a specific cognitive category (memory, cognitive flexibility, processing, attention, and memory). Participants randomised in the control group will perform the standard hemodialysis session three times a week for 12 weeks, without using virtual reality.
详细描述
The trial is a multicenter, parallel group, feasibility randomized controlled trial.
The trial population will include adult participants, who have the physical and cognitive capacity to be trained using immersive virtual reality and who have kidney failure on hemodialysis.
Participants will be allocated in the intervention (virtual reality session) or standard of care without the intervention. Participants will be allocated to intervention or standard care by randomization 1:1.
The virtual reality intervention will consist of computerized cognitive training of a subset of 4 short, gamified exercises. The intervention will be accessed through the Enhance VR platform on a Meta Quest 3S head mounted display, Snapdragon XR2 Gen2, processor, 8 Gb RAM, 128 Gb internal memory, resolution per eye in pixels: 1832 x 1920 with a refresh rate of 90-120 Hz and motion controllers. The clinician responsible for the intervention will be in the room with the participant, providing support for the intervention and any technical issues.
The chosen trial duration of 12 weeks is designed to provide exposure to a meaningful dose of cognitive training (three times a week) aligned to previous similar studies and to maximize participant tolerability to immersive virtual reality training.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants aged 18 years or older and less than or equal to 75 years of age
- •Receiving haemodialysis treatment for kidney failure for at least 90 days (permanent reduction in kidney function below an estimated glomerular filtration rate of 15 mL/minute per 1.73 m2)
- •Able to provide written and informed consent
- •Able to use the immersive virtual reality headset and follow instructions with sufficient motor, visual and auditory function to interact with the intervention
- •Able to speak and understand Italian language
排除标准
- •Severe cognitive impairment or psychiatric diseases leading to inability to follow instructions and use the virtual reality headset
- •Significant nystagmus and/or vertigo leading to inability to tolerate the virtual reality headset
- •Insufficient motor function to use the virtual reality system
- •Hearing or visual disability
- •Advanced or uncompensated chronic diseases unrelated to kidney failure (e.g. advanced cancer, heart failure, lung diseases with poor oxygen saturation)
- •Other neurological diseases (ictus, Alzheimer's or other forms of dementia)
- •Persistent pain or itch or who using opioids that may interfere with the tests or any other condition that the clinician may judge as influencing the results
研究组 & 干预措施
Virtual reality
Participants will use the virtual reality during the standard dialysis session for 30 minutes, three times a week for 12 weeks.
干预措施: Virtual reality platform on head mounted display (Device)
Standard care
Participants will perform the standard dialysis session three times a week for 12 weeks without virtual reality training sessions.
结局指标
主要结局
Proportion of adverse events
时间窗: 12 weeks
Proportion of randomized participants who have adverse event reporting completed at 12 weeks.
Accept the invitation to participate
时间窗: 4, 12 weeks
Proportion of screened patients who participate in one or more sessions of allocated virtual reality training.
Appropriateness of eligibility criteria
时间窗: 12 weeks
Recruitment rate during 12 weeks of recruitment phase.
Retention
时间窗: 12 weeks
Proportion of randomized participants who complete the intervention and complete follow-up at 12 weeks.
Acceptability
时间窗: 12 weeks
Proportion of randomized participants who complete \>80% of the treatments during 12 weeks follow-up.
Quality of life
时间窗: 0, 4, 12, 24 weeks
Proportion of randomized participants who complete the outcome measurements using the Kidney Disease Quality of Life Short Form 36 (KDQOL-36). The KDQOL-36 has five scales, including two generic health related quality of life scales from the SF-12 version 1 (12 items total) and three kidney-specific scales (24 items total). Each of the KDQOL-36 kidney-targeted scales are scored by transforming all items linearly to a 0-100 possible range and averaging the items in the scale. On the KDQOL-36, higher scores indicate better health realated quality of life.
次要结局
- Health utility(0 and 12 weeks)
- Depression(0, 4, 12, 24 weeks)
- Anxiety(0, 4, 12, 24 weeks)
- Quality of life(0, 4, 12, 24 weeks)
- Fatigue(0, 4, 12, 24 weeks)
- All-cause death(12 weeks)
- Cardiovascular events(12 weeks)
- Pulse(0 and 12 weeks)
- Systolic blood pressure(0 and 12 weeks)
- Diastolic blood pressure(0 and 12 weeks)
- Dialysis duration(0 and 12 weeks)
- Type of dialysis(0 and 12 weeks)
- Functional near-infrared spectroscopy(0 and 12 weeks)
- Kt/V(0 and 12 weeks)
- Hemoglobin(0 and 12 weeks)
- Glucose(0 and 12 weeks)
- Glycated hemoglobin(0 and 12 weeks)
- Serum creatinine(0 and 12 weeks)
- Serum albumin(0 and 12 weeks)
研究者
Davide Viggiano
Prof
University of Campania Luigi Vanvitelli