Innovative Cognitive-Motor Training for Prevention of AD/ADRD
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Dual-task Limits of Stability Test (LOS)
研究概览
简要总结
Alzheimer's disease and related dementias (AD/ADRD) greatly affect memory and daily activities in older adults. Mild Cognitive Impairment (MCI) is an early stage of dementia, affecting about 17% of older adults. People with MCI often show problems with gait and balance, which doubles their risk of falling compared to cognitively healthy peers. Falls can cause injuries, increase sedentary behavior, and reduce physical activity. This decline in activity can also speed up the progression from MCI to dementia. Exercise can help older adults make healthy lifestyle changes; however, most of the existing exercise programs focus mainly on physical movement rather than cognitive function. Therefore, the investigators developed a new program that uses computer vision and a cloud-based system to provide more scalable, engaging, and personalized cognitive-motor training for OAwMCI. The purpose of this study is to investigate the short- and long-term effects of a novel CogXergaming training (CXT) paradigm for improving the cognitive-motor function, physical activity, falls efficacy, and quality of life.
详细描述
Alzheimer's disease/Alzheimer's disease and related dementias (AD/ADRD) significantly impair cognitive function and the ability to perform activities of daily living in older adults. Mild Cognitive Impairment (MCI) is a transitional phase between age-associated cognitive decline and dementia, which affects about 17% of older adults and can impair multiple domains of cognitive functioning (executive function, memory, etc.). Further, there is a well-established relationship between cognitive decline and reduced mobility, and OAwMCI show gait and balance deficits compared to cognitively intact older adults (CIOA), resulting in a 2-fold increase in the risk of falling. Fall-related consequences (e.g., injury) can significantly increase sedentary behavior and reduce physical activity, thus leading to a vicious cycle of deconditioning and reduced mobility, which significantly increases the risk of experiencing another fall. Further, sedentary behavior and deconditioning can accelerate the rate of conversion from MCI to AD/ADRD.
Exercise interventions are a promising approach to not only improve motor function, balance, and mobility in OAwMCI but also to improve cognitive function via several mechanisms of action. However, few exercise interventions for OAwMCI explicitly target cognitive processing in challenging conditions, such as dual tasking (i.e., simultaneous motor+cognitive task). Exergaming is a form of dual-task training that could reduce CMI in OAwMCI by providing combined cognitive stimulation and motor training in challenging environments that activate multiple cognitive processes, using digital gaming platforms. However, most existing exergames have focused only on the physical domain (promoting physical activity or exercise), and there is limited evidence on whether exergaming yields more cognitive benefit than conventional training. To explicitly target cognitive function and dual tasking ability, the investigators have developed a novel paradigm that integrates advanced computer vision technology and a cloud-based platform to provide more scalable, engaging, and customizable cognitive-motor training for OAwMCI. This CXT paradigm overcomes barriers of commercial exergaming systems (Wii Fit, Kinect) and requires minimal technology (webcam, computer/tablet), thus being more scalable and cost-effective.
The current proposal will examine the effects of 8 weeks of CXT on dual tasking ability, balance, and mobility, and patient-centered outcomes in OAwMCI, compared to an exercise and education program (EEP).
Aim 1: Examine the immediate effects of CXT on mechanistic measures of CMI in OAwMCI by comparing the dual task costs during both volitional and reactive balance tasks between groups after 8 weeks of training.
Aim 2: Examine the immediate effects of CXT on dynamic balance, mobility, and endurance in OAwMCI, and the investigators will also compare the cognitive function using the NIH cognitive toolbox between groups immediately after the training (Ancillary Aim).
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
- None
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 55-90 years.
- •No recent major surgery, bone fracture, or hospitalization (< 3 months).
- •Not on any sedative drugs.
- •Can understand and communicate in English.
- •Can walk without an assistive device for at least 1 block to ensure independent functioning.
- •Identification of Mild Cognitive Impairment (MCI) based on Jak/Bondi criteria
- •Visual acuity greater than or equal to 20/40 with or without corrective lenses to ensure intact vision.
排除标准
- •Participants will not proceed with the study if any of the following occurs at baseline measurement: 1) Heart Rate >85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age), 2) systolic blood pressure (SBP) > 160 mmHg and/or diastolic blood pressure (DBP) > 110 mmHg during resting.
- •Unable to stand for 5 minutes without an assistive device and walk for 10 m without an assistive device
- •Complaints of shortness of breath, or uncontrolled pain (more than 3 out of 10 on Visual Analogue Scale), or if pulse oxygen drops less than 92% on the six-minute walk test (for endurance) to ensure that the participant can effectively participate without discomfort or injury during testing and training.
- •Exhibits difficulty understanding the study information.
- •Self-reported history or presence of any neurological, musculoskeletal, cardiorespiratory, or systemic disorders that significantly impact mobility or the ability to walk independently (without an assistive device).
- •Self-reported disability (with or without an assistive device) to ensure independent functioning.
- •Uncontrolled (not under any medications) hypertension to avoid cardiovascular complications during testing/training.
- •Weight >220 lbs (harness weight threshold).
研究组 & 干预措施
Novel CogXergaming Training
Customized Novel CogXergaming Training based on cognitive-motor balance training will be delivered to Participants in group A. Participants will undergo 18 sessions of training for eight weeks, with around 60 minutes of training per session, i.e., 3 sessions per week in the first 2 weeks, and 2 sessions per week in the remaining 6 weeks. All the CXT training will be performed using a desktop with a webcam.
干预措施: Novel CogXergaming Training (Behavioral)
Exercise and Education Training Program
Participants in Group B will complete 8 weeks of a conventional exercise program and fall-prevention education (3x/week in the first 2 weeks and 2x/week in the remaining 6 weeks, 18 sessions total) in the lab.
干预措施: Exercise and Education Training Program (Behavioral)
结局指标
主要结局
Dual-task Limits of Stability Test (LOS)
时间窗: Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)
Measures changes in max excursion under dual-task conditions during the LOS test compared to the single-task.
Mini-BESTest
时间窗: Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)
Assesses 4 domains: anticipatory and reactive balance control (therapist-induced), sensory orientation, and gait. The value ranges from 0 to 28, and higher scores indicate better balance control.
Physical Activity Scale of Elderly (PASE)
时间窗: Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)
Self-reported measure of physical activity levels in older adults. The score ranges from 0 to 799, higher scores indicate greater physical activity level.
Activities Specific Balance Confidence (ABC)
时间窗: Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)
Assesses an individual's confidence in maintaining balance during various daily activities. The score ranges from 0 to 100, and higher scores indicate greater confidence in maintaining balance during activities
次要结局
- Dual-task Stance Perturbation Test (SPT)(Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21))
- Timed up and go (TUG)(Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21))
- Weekly # of steps(Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21))
- 6 Minute Walk Test (6MWT)(Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21))
- 36-Item Short Form Survey (SF-36)(Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21))
- NIH motor toolbox- standing balance test(Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21))
- NIH motor toolbox- 4-meter walking test.(Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21))
研究者
Wang Shuaijie
Research Associate Professor
University of Illinois at Chicago