Modulation Effects of Baduanjin Mind-body Exercise on Subjective Cognitive Decline
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Functional connectivity of hippocampus and DLPFC
研究概览
简要总结
The aim of this study is to investigate the modulation effects of Baduanjin (BDJ), a simple and innovative mind-body exercise, on cognitive function, resting state functional connectivity, and brain morphometry in individuals with subjective cognitive decline (SCD). The results obtained will provide novel insights for improving the prevention of age-related cognitive decline and Alzheimer's disease.
详细描述
Subjective cognitive decline (SCD), the self-reported perception of memory or cognitive problems, is receiving increasing attention as a risk factor for the development of Alzheimer's disease (AD). Since SCD manifests before the onset of clinical impairment, it might be the optimal stage/window of time at which to intervene with preventative therapies for AD and age-related dementia before the progressive neurological loss and irreversible cognitive impairment.
Recently, mind-body interventions have demonstrated their potential in preventing cognitive decline. Nevertheless, these mind-body therapies encompass a family of complex practices, each with different characteristics and focus. Therefore, they may be associated with different mechanisms and treatment effects. Baduanjin (BDJ) is an innovative and simple mind-body exercise consisting of eight simple movements that can be easily practiced at home with video guidance, thereby making it a more suitable option for older adults with cognitive decline than other more complex exercises.
We believe that this study will 1) significantly improve the prevention of MCI and AD and directly benefit patients suffering from these highly prevalent disorders, 2) enhance the investigators' understandings of the neurobiology through which mind-body interventions affect cognition and health, and 3) advance the investigators' understandings of the pathophysiology and development of SCD, AD, and age-related dementia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •50 - 80 years old
- •Self-reported experience of persistent decline in memory compared with a previous state (within the past 5 years), which was further confirmed by informants
- •Concerns regarding memory problems
- •Mini-Mental State Examination, Second Edition (MMSE-2) scores within the normal range
- •Montreal Cognitive Assessment scores within the normal range (adjusted for age, sex, and education)
- •Clinical Dementia Rating score of 0 (no memory loss or slight, inconsistent forgetfulness)
排除标准
- •Unable to speak or read English
- •Diagnosis of depression
- •Other diseases that cause cognitive decline (e.g., traumatic brain injury, stroke, neurodegenerative diseases, brain tumor, Parkinson disease, encephalitis or epilepsy, thyroid dysfunction, severe anemia, syphilis)
- •History of psychosis or congenital mental growth retardation
- •Any delayed recall index greater than 1.5 SD below average on the California Verbal Learning Test, Second Edition
- •Failing the Memory items on the MMSE-2 and MDRS-2, as well as the CVLT-II criterion
- •Inability to participate in a 6-month intervention with a 3-month follow-up
- •Any item = 0 on the Lawton-Brody Instrumental Activities of Daily Living Scale for cognitive reasons
- •No available informant
- •Previous diagnosis of MCI, AD, or other age-related dementia
- •Previous Baduanjin experience
结局指标
主要结局
Functional connectivity of hippocampus and DLPFC
时间窗: baseline, 3, 6 months
Resting state functional connectivity of the hippocampus and dorsolateral prefrontal cortex (DLPFC) based on resting state functional magnetic resonance imaging (fMRI) data will be used.
Alzheimer Disease Cooperative Study- Preclinical Alzheimer (ADCS-PACC) Cognitive Composite
时间窗: baseline, 3, 6, 9 months
The ADCS-PACC is a composite of well-validated neuropsychological tests that were selected specifically due to their sensitivity in tracking the earliest evidence of decline from normal to subtly abnormal cognitive performance.
次要结局
- Patient Reported Outcomes Measurement Information System 29 (PROMIS-29)(baseline, 3, 6, 9 months)
- Controlled Oral Word Association Test, Category Fluency and Category Switching(baseline, 3, 6, 9 months)
- Modified Brief Pain Inventory (BPI)(baseline, 3, 6, 9 months)
- Brain morphometry(baseline, 3, 6 months)
- Blood markers(baseline, 3, 6, 9 months)
- Heart rate variability(baseline, 3, 6, 9 months)
- Symbol Digit Modalities Test (SDMT)(baseline, 3, 6, 9 months)
- Patient Reported Outcomes Measurement Information System - Cognition Function and ability subset(baseline, 3, 6, 9 months)
- Brief Quantitative Sensory Testing (QST)(baseline, 3, 6, 9 months)
- The Stroop Color and Word Test (SCWT)(baseline, 3, 6, 9 months)
- Everyday Cognition -Subject/Self Report Form (ECog-self report and informant)(baseline, 3, 6, 9 months)
- Trail-making Test A and B(baseline, 3, 6, 9 months)
- The California Verbal Learning Test-II (CVLT-II)(baseline, 3, 6, 9 months)
- Beck Anxiety Inventory (BAI)(baseline, 3, 6, 9 months)
研究者
Jian Kong
Professor
Massachusetts General Hospital