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: 10296565
• 负责人: Robert Wayne Motl
• 金额: $ 46.18万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 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 2021-10-11
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10296565
• 关键词: Accelerometer; Activities of Daily Living; Adult; American; Anxiety; Attention; Behavior Therapy; Behavioral; Blinded; Clinical; Cognition; Cognitive; Data Analyses; Devices; Digit structure; Fatigue; Functional disorder; Guidelines; Health; Impaired cognition; Impairment; Internet; Intervention; Investigation; Knowledge; Learning; Life Style; Logistic Regressions; Measures; Medical center; Memory; Mental Depression; Mission; Modality; Modeling; Multiple Sclerosis; Nature; Outcome; Outcome Assessment; Pain; 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; Supervision; Testing; Time; Translations; Travel; Waiting Lists; Walking; 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; post intervention; primary outcome; processing speed; programs; prospective; recruit; rehabilitation research; remote delivery; restoration; screening; secondary outcome; social

Cognitive impairment is prevalent, disabling, and poorly-managed among the 1 million Americans living with multiple sclerosis (MS). Indeed, 67% of adults with MS have cognitive impairment, particularly slowed cognitive processing speed (CPS), and this is associated with impaired learning and memory and worse fatigue, depression, anxiety, pain, 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 Class II 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, pain, and QOL. 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 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 highly-refined Internet-delivered PA intervention that focuses on walking during ambulatory activities of daily living (steps/day) 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 300 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 include a remotely-delivered, objective measure of learning and memory and self-reports of fatigue, depression, anxiety, pain, and QOL; the tertiary outcome is accelerometry as an objective, 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 outcomes on 3 occasions over a 12-month period (i.e., pre-intervention, immediately post-intervention, and 6-month follow-up). The outcomes 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 NCMRR’s mission.

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患者有认知障碍，特别是认知能力低下， 处理速度（CPS），这与学习和记忆受损以及更严重的疲劳有关， 抑郁、焦虑、疼痛和生活质量（QOL）。这强调了识别有效的 管理CPS损害及其后果的方法与MS。 远程交付的体力活动（PA）干预管理MS相关的CPS功能障碍，我们 已经提供了来自一项试点随机对照试验（RCT）的II类证据， 干预导致轻度MS相关患者的CPS有临床意义的改善， 行走障碍;疲劳、抑郁、焦虑、疼痛和QOL有额外改善。的 试点RCT没有事先招募有客观CPS损伤的MS患者，也没有检查 CPS的可持续性随着时间的推移而变化，它涉及一个等待名单控制，没有考虑到 注意力和社会联系。我们利用我们的经验和初步结果，并提出了一个 高度开发和高度完善的互联网传输PA的适当供电的第二阶段RCT 干预，重点是在日常生活的步行活动（步数/天），以产生 轻度MS相关患者远程评估CPS的即时和持续改善 CPS受损的行走障碍患者。拟议的研究，如果成功，将提供I类 关于6个月的互联网提供的PA干预与活性药物相比的有效性的证据 在300名患有轻度MS的成年MS患者中改善重要结局的对照条件 行走障碍和受损的CPS。主要成果是远程交付的符号数字 模态测试作为CPS的测量;次要结局包括远程交付的客观 学习和记忆的测量以及疲劳、抑郁、焦虑、疼痛和QOL的自我报告;第三 结果是加速度计作为PA的客观的、基于设备的测量。这些条件将由 不参与筛选、招募、随机分配和结果评估的人员。我们将 在12个月期间收集3次结果（即，干预前，干预后立即， 6个月随访）。将使用设盲评估员收集结局。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。拟议的研究与NCMRR的使命进一步一致。