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

认知障碍在100万生活在一起的美国人中普遍存在，导致残疾，而且管理不善 多发性硬化(MS)。事实上，67%的患有多发性硬化症的成年人表现出认知障碍，尤其是速度减慢 认知处理速度(CPS)，这与更差的疲劳、抑郁、焦虑和质量有关 生活质量(QOL)。这强调了确定有效的方法来管理CPS的重要性 多发性硬化症患者的损害及其后果远程体育锻炼是有好处的 (PA)对多发性硬化症相关CPS功能障碍的干预我们提供了一名飞行员的证据， 互联网传递的PA干预导致临床有意义的随机对照试验(RCT) 轻度多发性硬化症相关活动障碍患者的CPS改善； 改善疲劳、抑郁、焦虑和生活质量。重要的是，飞行员RCT并没有先验地招募 患有客观CPS损害的多发性硬化症患者，也不检查CPS随时间变化的可持续性， 它还包括一个等待名单控制，没有考虑到注意力和社交联系的影响。我们 利用我们的经验和初步成果，提出适当支持的第二阶段RCT 高度发达和完善的互联网提供的PA干预，可实现即时和持续的效果 改善轻度多发性硬化症相关活动障碍患者的远程评估CPS 证明CPS受损。拟议的研究如果成功，将提供关于 为期6个月的互联网传播的PA干预与积极控制条件下的疗效比较 改善280名患有轻度多发性硬化症活动障碍的成人多发性硬化症患者的重要结局 CPS受损。主要结果是远程交付的符号数字模式测试，作为一种测量 CPS；第二结果是疲劳、抑郁、焦虑和生活质量的自我报告；第三结果是 结果是加速度法作为一种基于设备的PA测量方法。条件将由符合以下条件的人提供 不参与筛选、招聘、随机分配和结果评估。我们会收集 12个月期间3次结果数据(即干预前、干预后立即和 6个月随访)。结果数据将使用盲人评估员收集。数据分析将涉及 意向治疗原则、混合效应模型和Logistic回归。拟议的研究可能会产生 可用于治疗CPS损害的自由生活PA改变的“现实世界”指南 在女士中，这是一个使用广泛的方法恢复认知功能的机会， 考虑到CPS损害的普遍、禁用和管理不善的性质，可扩展性至关重要 多发性硬化症和有限的治疗资源。拟议的研究进一步与国家 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。

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.