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

基本信息

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
项目类别：
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

项目摘要

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 万患有认知障碍的美国人中，认知障碍很普遍，造成残疾且管理不善。事实上，67% 的多发性硬化症成年人存在认知障碍，尤其是认知减慢。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) 这强调了确定有效方法的重要性。管理多发性硬化症患者 CPS 损伤及其后果的方法是有优点的。远程身体活动 (PA) 干预用于管理 MS 相关的 CPS 功能障碍。已提供来自一项试点随机对照试验 (RCT) 的 II 类证据，表明互联网交付的 PA 干预使轻度 MS 相关患者的 CPS 得到临床有意义的改善行走障碍；疲劳、抑郁、焦虑、疼痛和生活质量也有额外改善。试点随机对照试验并未预先招募具有客观 CPS 损伤的多发性硬化症患者，也未检查 CPS 的可持续性随着时间的推移而变化，并且它涉及候补名单控制，该控制没有考虑以下因素的影响：我们利用我们的经验和初步结果以及报价。高度开发和高度完善的互联网交付 PA 的适当供电的第二阶段 RCT 重点关注日常生活步行活动（步数/天）中步行的干预措施轻度 MS 相关患者的远程评估 CPS 立即持续改善表现出 CPS 受损的行走障碍。拟议的研究如果成功，将提供 I 级。关于为期 6 个月、通过互联网提供的 PA 干预与积极治疗相比的有效性的证据控制病情以改善 300 名患有轻度多发性硬化症的成人患者的重要结果行走障碍和 CPS 受损的主要结果是远程传送的符号数字。作为 CPS 衡量标准的模式测试；次要结果包括远程交付的客观结果学习和记忆的测量以及疲劳、抑郁、焦虑、疼痛和生活质量的自我报告；结果是加速度测量作为 PA 的客观、基于设备的测量。条件将由不参与筛选、招募、随机分配和结果评估的人员。在 12 个月期间收集 3 次结果（即干预前、干预后立即、和 6 个月的随访）。结果将由盲评估员收集。数据分析将涉及。意向治疗原则、混合效应模型和逻辑回归可能会产生结果。可用于治疗 CPS 损伤的自由生活 PA 改变的“现实世界”指南在多发性硬化症中，这是一个使用具有广泛影响力的方法来康复认知功能的机会。考虑到 CPS 损伤的普遍性、致残性和管理不善的性质，可扩展性至关重要 MS 及其治疗资源有限。拟议的研究进一步符合 NCMRR 的使命。