Internet-Delivered Lifestyle Physical Activity Intervention for Cognitive Processing Speed in Multiple Sclerosis

互联网提供的生活方式身体活动干预可提高多发性硬化症的认知处理速度

• 批准号: 10584958
• 负责人: Robert Wayne Motl
• 金额: $ 48.32万
• 依托单位: UNIVERSITY OF ILLINOIS AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10584958
• 关键词: Accelerometer; Adult; American; Anxiety; Attention; Behavior Therapy; Behavioral; Blinded; Clinical; Cognitive; Data; Data Analyses; Development; Devices; Digit structure; Fatigue; Fostering; Functional disorder; Guidelines; Health; Impaired cognition; Impairment; Internet; Intervention; Investigation; Knowledge; Life Style; Logistic Regressions; Measures; Medical center; Mental Depression; Mission; Modality; Modeling; Multiple Sclerosis; Nature; Outcome; Outcome Assessment; Patient Self-Report; Persons; Pharmacotherapy; Phase; Physical activity; Productivity; Public Health; Quality of life; Randomized; Randomized Controlled Trials; Rehabilitation therapy; Reporting; Research; Resources; Single-Blind Study; Stimulus; Supervision; Testing; Time; Translations; Travel; Waiting Lists; active control; attentional control; base; clinical practice; cognitive function; cognitive performance; cognitive rehabilitation; comparison intervention; cost; depressive symptoms; design; disability; disabling disease; efficacy evaluation; evidence base; exercise intervention; experience; follow-up; improved; innovation; intervention delivery; multiple sclerosis patient; novel; post intervention; primary outcome; processing speed; programs; prospective; recruit; rehabilitation research; remote assessment; remote delivery; restoration; screening; secondary outcome; social contact

Cognitive impairment is prevalent, disabling, and poorly-managed among the 1 million Americans living with multiple sclerosis (MS). Indeed, 67% of adults with MS demonstrate cognitive impairment, particularly slowed cognitive processing speed (CPS), and this is associated with worse fatigue, depression, anxiety, and quality of life (QOL). This underscores the importance of identifying efficacious approaches for managing CPS impairment and its consequences among those with MS. There is merit in a remotely-delivered physical activity (PA) intervention for managing MS-related CPS dysfunction in MS. We have provided evidence from a pilot, randomized controlled trial (RCT) that an Internet-delivered PA intervention resulted in a clinically meaningful improvement in CPS among those with mild MS-related ambulatory disability; there were additional improvements in fatigue, depression, anxiety, and QOL. Importantly, the pilot RCT did not a priori recruit persons with MS who had objective CPS impairment nor examine sustainability of CPS changes over time, and it further involved a waitlist control that did not account for the effects of attention and social contact. We leverage our experiences and preliminary results, and propose an appropriately-powered, Phase-II, RCT of a highly-developed and refined Internet-delivered PA intervention for yielding immediate and sustained improvements in remotely-assessed CPS among persons with mild MS-related ambulatory disability who demonstrate impaired CPS. The proposed study, if successful, will provide Class I evidence regarding the efficacy of a 6-month, Internet-delivered, PA intervention compared with an active control condition for improving important outcomes in 280 adults with MS who present with both mild MS ambulatory disability and impaired CPS. The primary outcome is the remotely-delivered Symbol Digit Modalities Test as a measure of CPS; the secondary outcomes are self-report measures of fatigue, depression, anxiety, and QOL; the tertiary outcome is accelerometry as a device-based measure of PA. The conditions will be delivered by persons who are uninvolved in screening, recruitment, random assignment, and outcome assessment. We will collect outcome data on 3 occasions over a 12-month period (i.e., pre-intervention, immediately post-intervention, and 6-month follow-up). The outcome data will be collected using a blinded assessor. Data analyses will involve intent-to-treat principles, and mixed-effects models and logistic regression. The proposed research may yield “real-world” guidelines for free-living PA change that can be implemented for the treatment of CPS impairment in MS. Such an opportunity for rehabilitation of cognitive function using an approach with broad reach and scalability is paramount considering the prevalent, disabling, and poorly-managed nature of CPS impairment in MS and limited resources for its treatment. The proposed research is further consistent with the National Center for Medical Rehabilitation Research’s mission of fostering the development of scientific knowledge for enhancing the health, productivity, independence, and QOL.

认知障碍在100万美国人中普遍存在，致残，管理不善， 多发性硬化症（MS）。事实上，67%的成年MS患者表现出认知障碍，特别是在认知障碍方面， 认知处理速度（CPS），这与更糟糕的疲劳，抑郁，焦虑和质量有关 生活（QOL）这强调了确定管理CPS的有效方法的重要性 损害及其后果之间的MS.有一个远程交付的体力活动的优点 (PA)治疗MS相关CPS功能障碍的干预措施。我们提供了来自试点的证据， 一项随机对照试验（RCT）表明，互联网提供的PA干预导致了一项具有临床意义的 轻度MS相关行走障碍患者的CPS改善; 改善疲劳、抑郁、焦虑和QOL。重要的是，试点RCT没有事先招募 患有MS的人有客观的CPS损伤，也没有检查CPS随时间变化的可持续性， 它还涉及等待列表控制，该控制没有考虑到注意力和社交接触的影响。我们 利用我们的经验和初步结果，并提出一个适当的动力，第二阶段，随机对照试验， 高度发达和完善的互联网提供的巴勒斯坦权力机构干预措施， 轻度MS相关行走障碍患者远程评估CPS的改善， 显示出受损的CPS。拟议的研究，如果成功，将提供I类证据， 6个月，互联网提供，PA干预与积极控制条件相比， 改善280例MS成人患者的重要结局，这些患者表现为轻度MS行走障碍， 受损的CPS主要结果是远程传递的符号数字模式测试，作为衡量 CPS;次要结局是疲劳、抑郁、焦虑和QOL的自我报告测量;第三结局是 结果是加速度计作为PA的基于设备的测量。这些条件将由以下人员提供： 不参与筛选、招募、随机分配和结果评估。我们将收集 12个月期间3次的结果数据（即，干预前、干预后即刻，以及 6-月随访）。将使用设盲评估员收集结局数据。数据分析将涉及 意向治疗原则、混合效应模型和逻辑回归。拟议的研究可能会产生 可用于治疗CPS损伤的自由生活PA改变的“真实世界”指南 这种认知功能康复的机会，使用广泛的方法， 考虑到CPS损害的普遍性、致残性和管理不善的性质， MS和有限的治疗资源。研究结果与国家 医学康复研究中心的使命是促进科学知识的发展， 提高健康、生产力、独立性和生活质量。