Multi-domain Online Therapeutic Investigation Of Neurocognition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Scores
研究概览
简要总结
The purpose of this study is to compare the effects of three on-line wellness interventions for improving physical and cognitive function and brain connectivity in adults who are at least 55 years old and are experiencing symptoms of memory and/or cognitive difficulties.
详细描述
The proposed study will perform a randomized, controlled trial (RCT) to compare the effects of three on-line wellness interventions for adults (age 55 years and older) who are experiencing memory and/or cognitive decline. Study participants will be randomly assigned to one of three on-line wellness interventions: (a) Tai Chi, (b) mindful movement course, or (c) health and wellness education course. All interventions will be one hour long, held on-line twice a week for 12 weeks. The co-primary outcomes are 3-month change in cognitive function (Alzheimer's Disease Assessment Scale - cognitive subscale, ADAS-cog) and functional brain connectivity within the default mode network (DMN). Secondary behavioral outcomes will include measures of specific cognitive processes (e.g., auditory memory, executive function, processing speed), physical function (e.g., mobility), anxiety, depression, fatigue, pain, sleep quality, social activities/social isolation, and quality of life. Secondary neuroimaging outcomes will include measures of functional connectivity in other intrinsic brain networks (e.g., salience, central executive, language), cerebral perfusion, and structural white matter integrity. The behavioral and imaging outcomes will be assessed at baseline and upon completion of the 12-week interventions. To assess durability of the behavioral effects of the interventions, the cognitive and behavioral outcomes will be assessed again 6 months after the completion of the interventions.
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)
盲法说明
The randomization sequence will be generated in advance by Dr. Chao's research team using a random number generator and will be maintained in a secure location. Individuals who collect or analyze outcome data will be blinded to group assignment.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 55 years
- •subjective cognitive complaints, defined as self-experienced persistent decline in cognitive capacity in comparison with a previously normal status and unrelated to an acute event
- •Montreal Cognitive Assessment (MoCA) score suggestive of Mild Cognitive Impairment (MCI) status (i.e., < 26)
- •English language fluency
- •Wireless internet connection at home
- •Willingness to travel to the San Francisco VA in northern California or UCLA in southern California for in-person assessments at baseline, after the 12-week interventions, and at the 36-week follow-up
- •Capacity to provide informed consent or legally authorized representative consent and participant assent.
排除标准
- •current or past Axis I psychiatric disorders, or recent unstable medical or neurological disorders
- •disabilities that prevent participation in on-line movement classes (e.g., primarily use wheel-chair, severe visual impairment that would limit ability to observe instructor's movement on screen or severe hearing impairment that would limit ability to hear instructor's directions)
- •insufficient English proficiency
- •limited life expectancy (i.e., enrolled in hospice, metastatic cancer)
- •plan to travel for > 1 week during 12-week intervention period
- •diagnosis of dementia per the DSM-5
- •MoCA score suggestive of dementia (i.e., <17)
- •started dementia medication (cholinesterase inhibitor or memantine) in past 3 months or plans to start dementia medication during study period
- •planning to start/change any psychoactive medication during study period
- •current participation in another research study
- •contraindications to magnetic resonance imaging (MRI), including claustrophobia severe enough to prevent MRI examination, presence of ferrometallic objects in the body that would interfere with MRI examination and/or cause a safety risk (e.g., pacemakers, implanted stimulators, pumps)
- •prior or current training in with Tai Chi, PLIE, or other mind-body practices
研究组 & 干预措施
Tai Chi
Participants will engage in 60-minute Tai Chi classes twice a week for 12 weeks. The classes will be live-streamed over the internet. Tai Chi is an ancient Chinese system of gentle physical exercise and stretching. It involves a series of movements performed in a slow, focused manner and accompanied by deep breathing.
干预措施: Tai Chi (Behavioral)
Gentle, Mindful Movement
Participants will engage in a gentle, mindful movement class twice a week for 12 weeks. The classes will be one hour long and will be live-streamed over the internet. The mindful movement classes will combine elements from a wide range of Eastern and Western exercise modalities, including occupational therapy, physical therapy, yoga, tai chi, Feldenkrais, Rosen Method, dance movement therapy and mindfulness meditation.
干预措施: Preventing Loss of Independence through Exercise (PLIE) (Behavioral)
Health and Wellness Education
Participants will engage in bi-weekly 60 minute sessions of Health and Wellness Education classes. The classes will be held on-line for 12 weeks.
干预措施: Health and Wellness Education (Behavioral)
结局指标
主要结局
Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Scores
时间窗: Change from baseline to 6 months after treatment ends.
The Alzheimer's Disease Assessment Scale-Cognitive Subscale is a brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia. ADAS-cog scores range from 0-70, with higher scores (≥ 18) indicating greater cognitive impairment.
Change in Default Mode Network (DMN) functional connectivity
时间窗: Change from baseline to 1-week post-treatment.
The default mode network (DMN) is a system of connected brain areas that show increased activity when a person is not focused on what is happening around them. Instead, the DMN is especially active when a person is engaged in introspective activities (e.g., daydreaming, or contemplating the past or future). Research suggests that the DMN is disrupted in people with Mild Cognitive Impairment (MCI) and Alzheimer's disease (AD). Functional connectivity can be defined as the similarity between brain signals that arise from two anatomically separated brain regions. Similarity between the brain signals can be analyzed using Pearson's correlation.
Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Scores
时间窗: Change from baseline to 1-week post-treatment.
The Alzheimer's Disease Assessment Scale-Cognitive Subscale is a brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia. ADAS-cog scores range from 0-70, with higher scores (≥ 18) indicating greater cognitive impairment.
次要结局
- Change in Verbal Fluency scores(Change from baseline to 6 months after treatment ends.)
- Change in Auditory Memory scores(Change from baseline to 6 months after treatment ends.)
- Change in Mobility(Change from baseline to 6 months after treatment ends.)
- Change in Salience Network functional connectivity(Change from baseline to 1-week post-treatment.)
- Change in Language Network functional connectivity(Change from baseline to 1-week post-treatment.)
- Change in Attention/Executive Function Cognitive Domain Scores(Change from baseline to 6 months after treatment ends.)
- Change in Processing Speed Scores(Change from baseline to 6 months after treatment ends.)
- Change in Auditory Memory scores(Change from baseline to 1 week post-treatment.)
- Change in Attention/Executive Function Cognitive Domain Scores(Change from baseline to 1-week post-treatment.)
- Change in Verbal Fluency scores(Change from baseline to 1-week post-treatment.)
- Change in Processing Speed Scores(Change from baseline to 1-week post-treatment.)
- Change in Mobility(Change from baseline to 1-week post-treatment.)