An Integrated Intervention of Computerized Cognitive Training and Physical Exercise in Virtual Reality for People With Alzheimer's Disease: the JDome Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- change in cognitive impairment
研究概览
简要总结
JDOME is a randomized controlled trial to test the effectiveness of a computerized cognitive training with the Brainer web platform and aerobic training with the JDOME system vs. a computerized cognitive training with the Brainer web platform and aerobic training with a standard exercise bike in subjects with Alzheimer's Disease at early stage. The JDome BikeAround is a tool that take people with dementia on a virtual bicycle tour along the paths of memories. It combines an exercise bike, a dome-shaped projector and Google Street View technology.
详细描述
JDOME study is designed as a randomized controlled trial to test the effectiveness of a training that combines the JDome virtual reality system for aerobic exercise with computerized cognitive training via tablet. The Experimental Group (EG) will receive computerized cognitive training with the Brainer web platform and aerobic training with the JDOME system (a tool that combines an exercise bike, a dome-shaped projector and Google Street View technology).The Control Group (CG) will receive computerized cognitive training with the Brainer web platform and aerobic training with a standard exercise bike.
Assessment will be performed at the baseline (T0), at the end of intervention (after eight weeks -T1) and 12 weeks after the end of intervention (follow-up T2).
The primary aim is to assess the stabilization of the global cognition of people with mild-stage Alzheimer's disease at the Mini-Mental State Examination (MMSE) and at the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog); The secondary aim is the analyses of the modification of the quality of life, mood, behavioral disturbances, and physical function in people with mild-stage Alzheimer's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 65 and over;
- •Pre-existing diagnosis of Alzheimer's, in mild phase, according to the 2011 criteria of the National Institute on Aging-Alzheimer's Association (NIA-AA);
- •Clinical Dementia Rating Scale CDR = 1;
- •Mini Mental State Examination MMSE > 19;
- •Functional Ambulation Categories FAC ≥4;
- •Tinetti scale ≥ 20;
- •Presence of a contact family caregiver
- •Reside at home
排除标准
- •Failure to meet the inclusion criteria
- •Sensory deficits not compensated by the use of prostheses
- •Psychological and behavioral disorders not compensated by drug treatment
- •Medical contraindication to moderate intensity aerobic exercise
结局指标
主要结局
change in cognitive impairment
时间窗: baseline, 8, and 22 weeks later
Mini-Mental State Examination was designed as a clinical method for grading cognitive impairment. The score ranges from 0 to 30: scores ≥ 24 indicate normality, between 18-23 indicate mild cognitive impairment, between 11-17 moderate cognitive deficits, scores ≤ 10 severe cognitive impairments. The reported score will be corrected according to age and education.
change in short and medium term memory
时间窗: baseline, 8 and 22 weeks later
Alzheimer's Disease Assessment Scale (ADAS-cog) consists of 11 items that investigate: short and medium term memory, language, praxia (simple, constructive, ideational), temporal-spatial orientation. The score ranges from 0 (no cognitive impairment) to 70 (maximum cognitive impairment).
次要结局
- change in signs and symptoms of major depression(baseline, 8 and 22 weeks later)
- change in physical performance(baseline, 8 and 22 weeks later)
- change in neuropsychiatric disturbances(baseline, 8 and 22 weeks later)
- change in quality of life(baseline and 8, 22 weeks later)