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.

项目概要/摘要 体力活动是阿尔茨海默病和相关痴呆症的保护因素。虽然有很多 尽管智力障碍 (ID) 成年人通常不会进行健康的体育活动 活动水平。由于患有智力障碍的成年人早发性痴呆和与年龄相关的疾病的发生率较高， 制定改进的战略和计划来促进这一人群的身体活动至关重要。 身体活动的障碍包括缺乏包容性的身体活动机会、缺乏融入社区的机会 锻炼设施以及对外部支持的依赖。 NIH 第一阶段混合方法研究的目的是 测试可行性、可接受性、保真度，并为多层次物理的第二阶段功效研究做准备 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，以帮助患有智力障碍的成年人更多地参与该计划 通过基于网络的交互式仪表板独立进行。患有智力障碍的成年人与支持教练一起工作 通过参与增加每日步数和进行中度至剧烈体力活动的时间 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 在社会生态模型的个人层面上建立以家庭为基础的计划，以包括社区层面 通过每周包容性团体健身课程（第 1A 阶段）。此阶段将包括可用性测试、试点测试 随机对照试验（RCT）评估组，以及对具有 ID 和调查和焦点的成年人的半结构化访谈 与其他利益相关者（父母、护理人员和运动专业人士）组成的小组来展示 基于网络的交互式仪表板的特性和功能。目标 2 是进行随机试点 对照试验（1B 阶段）。此阶段将采用候补名单控制实验设计，其中 120 名患有 ID 的成年人参与其中。 两个地点（北卡罗来纳州和德克萨斯州）。将通过衡量招聘情况来定量评估可行性， 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有关消费者可接受性的反馈。内容专家将 通过查看录像会话的子样本来评估治疗保真度。我们将衡量影响 Step It Up+ 增加体力活动并探索有关潜在功效的假设 干预对身体活动的影响。我们将使用每日步数来比较身体活动的主要结果 计数、活动强度分钟数、身体成分以及健康、功能和健康的次要结果 社会归属感。该项目的研究结果将为 R01 的大规模应用奠定必要的基础。 对出现 AD/ADRD 症状前的智力障碍成人进行第 2 阶段初级预防试验。我们的长期 术语目标是通过包容性的社区环境促进健康的体育活动行为，检查 这些计划对预防老年人阿尔茨海默病和相关痴呆症的长期影响 智障人士，并改善智障成年人的福祉。