The Promotion of Physical Activity for the Prevention of Alzheimer's Disease in Adults with Down Syndrome

促进体力活动预防患有唐氏综合症的成人患阿尔茨海默病

• 批准号: 10840170
• 负责人: Joseph E. Donnelly
• 金额: $ 15.21万
• 依托单位: UNIVERSITY OF KANSAS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-01 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10840170
• 关键词: Accelerometer; Adult; Age; Alzheimer disease prevention; Alzheimer' s Disease; Alzheimer' s disease risk; Attention; Brain; Brain region; Caregivers; Cerebrovascular Circulation; Cognition; Dementia; Development; Down Syndrome; Education; Educational Materials; Effectiveness; Exercise; Face; Feedback; Financial Hardship; Frequencies; Funding; Goals; Health; Health Educators; Home; Individual; Intellectual functioning disability; Intervention; Investigation; Magnetic Resonance Imaging; Measures; Methods; Monitor; Motor Skills; Participant; Pathology; Persons; Phase I Clinical Trials; Physical activity; Population; Public Health; Quality of life; Randomized; Reaction Time; Recommendation; Reporting; Research; Resources; Rest; Role; Safety; Short-Term Memory; Social Interaction; Social support; Tablet Computer; Time; Transportation; Videoconferencing; Weight maintenance regimen; age related; aging brain; arm; brain health; brain volume; cardiovascular fitness; cognitive function; confirmatory trial; design; health training; high risk; improved; meetings; moderate-to-vigorous physical activity; non-demented; pedometer; peer; physical inactivity; portability; prevent; remote delivery; response; treatment as usual; video chat; young adult

Abstract The number of people with Down syndrome (DS) living the U.S. has grown from ~50,000 to ~250,700 over the past 70 yrs. Nearly all individuals with DS display pathology associated with Alzheimer's disease (AD) beginning as early as age 30. Previous research in typically developed adults suggests that increased moderate-to-vigorous physical activity (MVPA) may improve cognitive function and protect against age-related structural and functional changes in the brain; however, the potential impact of increased MVPA on the development of AD in adults with DS has not been evaluated. Despite the potential positive impact of MVPA on cognition and AD risk, participation in MVPA among young adults with DS is low. The limited research evaluating strategies for increasing MVPA in adults with DS and has been unsuccessful in increasing short- term (≤ 12 wks.) or long-term MVPA (12 mo.). Results from our preliminary investigation (12 wks.) which remotely delivers real-time MVPA, led by a trained health coach, to groups of adults with DS in their homes (n=27), via video conferencing on a tablet computer demonstrated high attendance, increased MVPA during group sessions, and improvements in cognitive function. However, the sustainability, impact on total daily MVPA, optimal session frequency, and potential impacts on cognitive function and brain health of remotely delivered group MVPA sessions in adults with DS are unknown. Therefore, we propose a 12 mo. early stage clinical trial in 80 non-demented adults with DS to determine the feasibility and potential efficacy of remotely delivered group MVPA sessions to increase daily MVPA, relative to a usual care control. Participants will be randomized to attend 40 min remotely delivered group MVPA sessions at a low frequency (1 session/wk.,RL), high frequency (3 sessions/wk., RH), or usual care control. Content for both the RL and RH arms will be identical with the exception of group session frequency (1 vs. 3/wk.). Consistent with the funding announcement PAR-18-877 this trial will assess the feasibility and potential effectiveness of the RL, RH, and UC interventions on MVPA, and gather initial estimates of the impact of MVPA on cognition and measure of brain health related to AD in adults with DS. This information is required to inform the development of adequately powered, late stage confirmatory trials to evaluate the role of increased MVPA to prevent or delay AD in adults with DS. Our primary aim will assess daily MVPA (min) in the RL, RH, and UC arms at baseline, 3, 6, 9, and 12 mos., and obtain effect sizes for change in MVPA over 12-mos. Secondary aim 1 will assess the impact of MVPA across the RL, RH, and UC arms on cardiovascular fitness, quality of life, cognitive function and brain parameters related to AD (whole and regional brain volume, functional connectivity, resting state MRI, cerebral blood flow) at baseline, 6, and 12 mos. Secondary aim 2 will determine the feasibility (retention, session attendance, use of recorded sessions (RH/RL only) and safety) of RL, RH, and UC arms.

摘要 在过去的几年里，生活在美国的唐氏综合症(DS)患者的数量从大约50,000人增加到大约250,700人 已经过了70年了。几乎所有的DS患者都表现出与阿尔茨海默病(AD)相关的病理。 早在30岁时就开始了。之前对典型发育成年人的研究表明， 中等到剧烈的体力活动(MVPA)可能会改善认知功能，防止与年龄相关的疾病 大脑结构和功能的变化；然而，MVPA增加对 AD在成人DS患者中的发展尚未得到评估。尽管MVPA对 在认知和AD风险方面，患有DS的年轻人参与MVPA的比例较低。有限的研究 评估增加成人DS患者MVPA的策略，但在增加短... Term(≤12周)或长期MVPA(12个月)。初步调查结果(12周)哪一个 在训练有素的健康教练的带领下，远程向家中患有DS的成年人群体提供实时MVPA (n=27)，通过平板电脑上的视频会议，上座率高，MVPA在 小组会议和认知功能的改善。然而，可持续性，对总日均的影响 MVPA、最佳会话频率以及对远程患者认知功能和脑健康的潜在影响 在患有DS的成年人中，MVPA的接生组会话尚不清楚。因此，我们建议12个月。早期阶段 80例非痴呆成人DS患者的临床研究 与常规护理对照相比，提供小组MVPA课程以增加每日MVPA。参与者将是 随机以低频率(1次/周，RL)参加40分钟远程递送的组MVPA会话， 高频率(3次/周，RH)，或常规护理控制。RL和RH臂的内容都将是 除了小组会议频率(1次/周比3次/周)外，情况相同。与资金来源一致 公告PAR-18-877本试验将评估RL、RH和 UC对MVPA的干预，并收集MVPA对认知和测量的影响的初步估计 成年DS患者与AD相关的脑健康状况。需要此信息才能为 提供充足动力的后期验证性试验，以评估增加的MVPA预防或延迟的作用 成人DS患者中的AD。我们的主要目标是评估RL、RH和UC臂在基线时的每日MVPA(分钟)， 3、6、9和12个月，并获得12个月内MVPA变化的影响大小。次要目标1将评估 横跨RL、RH和UC臂的MVPA对心血管健康、生活质量、认知的影响 与AD相关的功能和脑参数(整体和局部脑体积、功能连接性、静息 状态MRI、脑血流量)在基线、6和12个月时。次要目标2将确定可行性 (保留、出席会议、使用录制的会议(仅限RH/RL)和安全)。