A Stage 1 Pilot Test for Feasibility and Efficacy of a Multi-Level Intervention To Increase Physical Activity in Adults with Intellectual Disability: Step it Up +

第一阶段试点测试多层次干预措施的可行性和有效性，以增加智力障碍成人的体力活动：加快步伐

• 批准号: 10585633
• 负责人: Kara Hume
• 金额: $ 76.36万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-01 至 2028-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10585633
• 关键词: Adult; Aerobic Exercise; Affect; Age of Onset; Age-associated memory impairment; Aging; Alzheimer disease prevention; Alzheimer' s Disease; Alzheimer' s disease related dementia; Behavior; Behavioral; Biological Markers; Body Composition; Caregivers; Chronic Disease; Clinical; Clinical Trials; Code; Communities; Control Groups; Data; Dementia; Diabetes Mellitus; Disease; Early Onset Alzheimer Disease; Evidence based practice; Exercise; Experimental Designs; Feedback; Focus Groups; Future; General Population; Goals; Heart Diseases; Home; Individual; Intellectual functioning disability; Intervention; Interview; Light; Link; Long-Term Effects; Longevity; Longitudinal Studies; Manuals; Measures; Medical; Methods; Modeling; Monitor; Neurocognitive; North Carolina; Online Systems; Parents; Personal Satisfaction; Phase; Physical activity; Physiological; Pilot Projects; Population; Prevention; Prevention trial; Primary Prevention; Public Health; Randomized; Randomized, Controlled Trials; Research; Risk; Self Management; Services; Severities; Site; Social outcome; Step Tests; Strenuous Exercise; Structure; Surveys; Symptoms; Technology; Testing; Texas; Theory of Change; Time; Training Activity; Treatment Efficacy; United States National Institutes of Health; Videotape; Visual; Waiting Lists; Weight; Work; access disparities; actigraphy; age related; biobehavioral measurement; clinical trial protocol; community setting; cost effective; dashboard; design; disorder prevention; early onset; economic impact; efficacy study; exercise intervention; feasibility testing; fitness; follow-up; high risk population; implementation barriers; improved; informal care; innovation; intervention effect; intervention program; member; moderate-to-vigorous physical activity; mortality; mortality risk; pilot test; prevent; primary outcome; programs; protective factors; recruit; secondary outcome; social; strength training; usability; willingness

PROJECT SUMMARY/ABSTRACT Physical activity is a protective factor of Alzheimer's disease and related dementias. While there are many benefits to physical activity, adults with intellectual disability (ID) often do not engage in healthy physical activity levels. With higher rates of early-onset dementias and age-related conditions in adults with ID, developing improved strategies and programs that promote physical activity in this population is critical. Barriers to physical activity include a lack of inclusive physical activity opportunities, access to community exercise facilities, and reliance on external supports. The purpose of this NIH Stage 1 mixed methods study is to test the feasibility, acceptability, fidelity, and prepare for a Stage 2 efficacy study of a multi-level physical activity intervention. Step It Up+ is a 16-week multi-level program that utilizes self-management strategies, including goal setting, self-monitoring, and visual supports to help adults with ID engage in the program more independently through an interactive web-based dashboard. Adults with ID work with a support coach to increase daily step counts and time spent in moderate-to-vigorous physical activity by engaging in individualized aerobic and strength training activities. Aim 1 is to modify, adapt, and refine our existing Step It Up home-based program at the individual level of the socioecological model to include the community level through a weekly inclusive group fitness class (Stage 1A). This phase will include usability testing, pilot testing of the RCT assessment battery, and semi-structured interviews with adults with ID and surveys and focus groups with additional stakeholders (parents, caregivers, and exercise professionals) to demonstrate the features and functionality of the interactive web-based dashboard. Aim 2 is to conduct a pilot randomized controlled trial (Stage 1B). This phase will use a waitlist control experimental design with 120 adults with ID in two sites (North Carolina and Texas). Feasibility will be assessed quantitatively by measuring recruitment, attendance, and completion rates. Qualitative data from focus groups and interviews will augment the feasibility quantitative findings and provide feedback on consumer acceptability. Content experts will evaluate treatment fidelity by reviewing a subsample of video-taped sessions. We will measure the impact of Step It Up+ on increasing physical activity and explore hypotheses regarding the potential efficacy of the intervention's effect on physical activity. We will compare primary outcomes of physical activity using daily step counts, activity intensity minutes, body composition, and secondary outcomes of wellbeing, functioning, and social belonging. The findings from this project will lay the essential groundwork for a large-scale, for an R01 to conduct a Stage 2 primary prevention trial in adults with ID who are pre-symptomatic of AD/ADRD. Our long- term goal is to promote healthy physical activity behaviors through inclusive community settings, examine the long-term impact of these programs in preventing Alzheimer's disease and related dementia in aging adults with ID, and improve wellbeing in adults with ID.

项目摘要/摘要 体力活动是阿尔茨海默病和相关痴呆症的保护因素。虽然有许多 由于身体活动的好处，智力残疾（ID）的成年人往往不参加健康的身体活动， 活动水平。在患有ID的成年人中，早发性痴呆和年龄相关疾病的发病率较高， 制定改进的战略和方案，促进这一人群的体育活动是至关重要的。 身体活动的障碍包括缺乏包容性的身体活动机会， 运动设施，以及对外部支持的依赖。这项NIH第1阶段混合方法研究的目的是 测试可行性，可接受性，保真度，并为多水平物理治疗的第2阶段疗效研究做准备 活动干预。Step It Up+是一个为期16周的多层次计划，利用自我管理策略， 包括目标设定、自我监控和视觉支持，以帮助ID成年人更多地参与该计划。 通过一个交互式的基于网络的仪表板独立地进行。有ID的成年人与支持教练一起工作， 增加每日步数和时间花在中度到剧烈的体力活动，通过参与 个性化的有氧和力量训练活动。目标1是修改、调整和完善我们现有的Step It 把以家庭为基础的方案从个人层面的社会生态模式纳入社区层面 通过每周一次的包容性团体健身课程（第1A阶段）。这一阶段将包括可用性测试、试点测试 随机对照试验评估电池，以及与ID成年人的半结构化访谈和调查， 与其他利益相关者（父母，护理人员和运动专业人员）一起参加的团体，以证明 基于Web的交互式仪表板的特性和功能。目的2是进行一项试验性随机 对照试验（第1B阶段）。这一阶段将使用一个等待名单控制实验设计，120名成年ID， 两个站点（北卡罗来纳州和德克萨斯州）。可行性将通过衡量招聘情况进行定量评估， 出勤率和完成率。来自焦点小组和访谈的定性数据将增加 可行性定量研究结果，并提供消费者接受程度的反馈。内容专家将 通过回顾录像会话的子样本来评估治疗保真度。我们将衡量 Step It Up+增加身体活动，并探索关于 干预对身体活动的影响。我们将使用每日步数比较体力活动的主要结果 计数、活动强度分钟数、身体成分以及健康、功能和 社会归属感该项目的研究结果将为R 01的大规模研究奠定必要的基础， 在AD/ADRD症状前的ID成人中进行第2阶段一级预防试验。我们长久以来- 长期目标是通过包容性的社区环境促进健康的体育活动行为， 这些项目在预防老年人阿尔茨海默病和相关痴呆症方面的长期影响 并改善ID成人的健康状况。