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

项目摘要 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)开始相关的病理 早在30岁的时候。以前对典型发达成年人的研究表明，中等到中等年龄的人增加 剧烈的体力活动(MVPA)可以改善认知功能，防止与年龄相关的结构性和老年性疾病 脑功能改变；然而，MVPA增加对AD发展的潜在影响 患有DS的成年人还没有得到评估。尽管MVPA对认知和AD风险有潜在的积极影响， 在患有DS的年轻人中，MVPA的参与率很低。有限的研究评价策略 增加患有DS的成年人的MVPA，但在增加短期(≤12周)方面不成功。或长期的 MVPA(12个月)。初步调查结果(12周)它远程提供实时的MVPA， 在训练有素的健康教练的带领下，通过视频会议在家中向患有DS的成年人群体(n=27)提供 平板电脑的出席率很高，小组会议期间MVPA增加， 认知功能。然而，可持续性、对每日MVPA总量的影响、最佳会话频率以及 远程团体MVPA训练对成人认知功能和脑健康的潜在影响 患有DS的人是未知的。因此，我们建议12个月。80例非痴呆成人痴呆的早期临床试验 DS以确定远程提供团体MVPA会议的可行性和潜在疗效，以增加 每日MVPA，相对于通常的护理控制。参与者将被随机安排参加40分钟远程授课 以低频率(1个会话/周，RL)、高频率(3个会话/周，RH)或通常护理对MVPA会话进行分组 控制力。除了组会话频率(1)之外，RL和RH臂的内容将相同 Vs.3/wk)。与资助公告PAR-18-877一致，这项试验将评估可行性和 RL、RH和UC干预对MVPA的潜在有效性，并收集对影响的初步估计 MVPA对成年DS患者阿尔茨海默病相关认知和脑健康指标的影响此信息为必填项 为发展提供充足动力的后期验证性试验，以评估增加的作用 MVPA预防或延缓成年DS患者的AD。我们的主要目标是评估RL，RH， 和UC ARM在基线、3、6、9和12个月时，并获得12个月后MVPA变化的影响大小。 次要目标1将评估跨RL、RH和UC臂的MVPA对心血管健康的影响， 与阿尔茨海默病相关的生活质量、认知功能和脑参数(整体和局部脑体积、功能 连接性、静息状态MRI、脑血流)在基线、6和12个月。次要目标2将决定 RL、RH和RL的可行性(保留、出席会议、使用录制的会议(仅限RH/RL)和安全性) 加州大学的手臂。

Project Summary 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.