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.

在100万美国人中，认知障碍普遍存在，残疾和管理不善 多发性硬化症（MS）。实际上，有67％的MS成年人具有认知障碍，尤其是认知速度缓慢 处理速度（CPS），这与学习和记忆力受损以及更严重的疲劳有关 抑郁，焦虑，疼痛和生活质量（QOL）。这强调了确定高效的重要性 管理CPS损伤及其后果的方法。有一个优点 用于管理MS中MS相关的CPS功能障碍的远程交付的体育活动（PA）干预措施。我们 已经从飞行员，随机对照试验（RCT）提供了II级证据，该试验（RCT）是互联网销售的PA 干预措施导致与MS相关的轻度相关的CP的临床有意义的改善 门诊残疾；疲劳，抑郁，焦虑，疼痛和生活质量还有其他改善。 Pilot RCT不是先验的招聘人员，他们的MS有客观的CPS损害或检查 CPS的可持续性会随着时间的推移而变化，并且涉及候补名单控制 注意力和社交接触。我们利用我们的经验和初步结果，并提出建议 高度发达且精心设计的Internet PA的适当动力，II期，II 侧重于在日常生活中行走（步骤/天）的干预措施 与MS有关 表现出CPS受损的卧床残疾。拟议的研究（如果成功）将提供I类 与活动相比 改善300名MS的成年人的重要结果的控制条件 门诊残疾和CPS受损。主要结果是远程交付的符号数字 模式测试作为CP的量度；次要结果包括远程交付的客观 衡量疲劳，抑郁，焦虑，痛苦和生活质量的学习和记忆和自我报告；第三级 结果是加速度计作为一种基于设备的PA的客观测量。条件将由 不参与筛查，招聘，随机分配和结果评估的人。我们将 在12个月的时间内收集3次（即干预前，干预后立即进行） 和6个月的随访）。结果将使用盲评估者收集。数据分析将涉及 意图对治疗原则以及混合效应模型和逻辑回归。拟议的研究可能会产生 可以实施用于治疗CPS损害的自由生活PA变更的“现实世界”指南 在MS中。这样的机会使用具有广泛影响力的方法来恢复认知功能 考虑到CPS障碍的普遍，残疾和管理不善的性质，可伸缩性至关重要 MS和有限的治疗资源。拟议的研究进一步与NCMRR的使命一致。