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: 10583850
• 负责人: Joseph E. Donnelly
• 金额: $ 15.19万
• 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 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10583850
• 关键词: Adult; Age; Alzheimer disease prevention; Alzheimer' s Disease; Alzheimer' s disease risk; Brain; Cerebrovascular Circulation; Cognition; Development; Down Syndrome; Effectiveness; Frequencies; Funding; Home; Individual; Intervention; Investigation; Magnetic Resonance Imaging; Measures; Participant; Pathology; Persons; Phase I Clinical Trials; Physical activity; Quality of life; Randomized; Research; Rest; Role; Safety; Tablet Computer; Time; Videoconferencing; age related; arm; brain health; brain volume; cardiovascular fitness; cognitive function; confirmatory trial; health training; improved; moderate-to-vigorous physical activity; non-demented; parent grant; prevent; remote delivery; treatment as usual; young adult

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.

项目摘要 生活在美国的唐氏综合症（DS）患者人数从2000年的约50，000人增加到250，700人。 几乎所有患有DS的个体显示与阿尔茨海默病（AD）开始相关的病理学， 早在30岁的时候。以前在典型发育的成年人中的研究表明，增加中度至 剧烈的体力活动（MVPA）可以改善认知功能，防止年龄相关的结构和 然而，增加MVPA对AD发展的潜在影响， 成人DS尚未进行评估。尽管MVPA对认知和AD风险有潜在的积极影响， 患有DS的年轻成年人中MVPA的参与率很低。有限的研究评估战略， 增加DS成人的MVPA，但在短期（≤ 12周）增加MVPA方面并不成功。或长期 MVPA（12个月）。我们初步调查的结果（12周）远程传送实时MVPA， 在一名训练有素的健康教练的带领下，通过视频会议， 平板电脑表现出较高的出勤率，在小组会议期间增加了MVPA， 认知功能然而，可持续性、对每日MVPA总量的影响、最佳会话频率和 成人远程MVPA治疗对认知功能和大脑健康的潜在影响 DS未知。因此，我们建议12个月。在80名非痴呆成年人中进行的早期临床试验， DS确定远程提供的小组MVPA会话的可行性和潜在有效性，以增加 每日MVPA，相对于常规护理对照。参与者将被随机分配参加40分钟的远程分娩 以低频率分组MVPA会话（1会话/周，RL），高频（3次/周，RH）或常规护理 控制RL和RH组的内容将相同，但组会话频率除外（1 vs. 3次/周）。根据PAR-18-877的资金公告，该试验将评估可行性， RL、RH和UC干预措施对MVPA的潜在有效性，并收集对影响的初步估计 MVPA对成人DS患者与AD相关的认知和脑健康的影响。需要此信息 为充分把握度的后期验证性试验的开发提供信息，以评估增加的 MVPA预防或延迟DS成人的AD。我们的主要目标是评估RL、RH、 和UC组在基线、3、6、9和12个月，并获得MVPA在12个月内变化的效应量。 次要目的1将评估RL、RH和UC组的MVPA对心血管健康的影响， 生活质量、认知功能和与AD相关的脑参数（全脑和局部脑体积、功能性 在基线、6个月和12个月时，连接性、静息状态MRI、脑血流量）。第二目标将决定 RL、RH的可行性（保留、会话出席率、记录会话的使用（仅RH/RL）和安全性），以及 UC武器。