Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.
Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.
Contemp Clin Trials. 2019 Dec;87:105878. doi: 10.1016/j.cct.2019.105878. Epub 2019 Nov 5.
Slowed cognitive processing speed (CPS) is a common and debilitating consequence of multiple sclerosis (MS) that is notoriously difficult to treat. As such, we undertook a systematic line of research that indicated that supervised, progressive treadmill walking exercise (TMWX) training might improve CPS and brain functioning among fully-ambulatory persons with MS. The current study will be the first adequately-powered, single-blind randomized controlled trial (RCT) that examines the efficacy of 12-weeks of TMWX training compared with an active control condition on CPS, thalamocortical brain connectivity (based on resting-state fMRI), and exploratory functional outcomes in 88 fully-ambulatory persons with MS who present with slowed CPS. The intervention condition involves supervised, progressive TMWX training 3 times/week over 12-weeks; this initially involves 15-min of light-to-moderate intensity TMWX that progresses up to 40-min of vigorous intensity TMWX. The active control condition involves supervised, minimal intensity, stretching-and-resistance exercise that will be delivered on the same frequency as the intervention condition. The primary study outcomes involve Symbol Digit Modalities Test performance (i.e., CPS) and fMRI-based measures of thalamocortical resting-state functional connectivity. Exploratory study outcomes involve measures of community participation, activities of daily living, quality of life, and functional mobility. All study outcomes will be administered before and after the 12-week study period by treatment-blinded assessors. If successful, the current study will provide the first Class I evidence for the effects of TMWX training as an approach for improving CPS and its neural correlate, and possibly mitigating the impact of slowed CPS on functional outcomes in MS.
认知处理速度（CPS）缓慢是多发性硬化症（MS）的常见且使人虚弱的后果，这种情况极难治疗。因此，我们进行了一系列系统的研究，表明监督、渐进式跑步机步行训练（TMWX）可能会改善完全活动能力的 MS 患者的 CPS 和大脑功能。目前的研究将是第一个充分-powered、单盲随机对照试验（RCT），检查 12 周 TMWX 训练与积极对照组相比在认知处理速度、丘脑皮质脑连接（基于静息状态 fMRI）以及在 88 名表现出认知处理速度缓慢的完全活动能力的 MS 患者中的探索性功能结果的疗效。干预条件涉及监督、渐进式 TMWX 训练，每周 3 次，持续 12 周；这最初涉及 15 分钟的轻度至中度强度 TMWX，逐渐增加到 40 分钟的剧烈强度 TMWX。积极对照组涉及监督、低强度、伸展和阻力运动，将以与干预条件相同的频率进行。主要研究结果涉及符号数字模态测试表现（即 CPS）和基于 fMRI 的丘脑皮质静息状态功能连接的测量。探索性研究结果涉及社区参与、日常生活活动、生活质量和功能移动性的测量。所有研究结果都将由治疗盲评估者在 12 周研究期前后进行管理。如果成功，目前的研究将为 TMWX 训练作为改善 CPS 及其神经相关的方法提供第一个 I 级证据，并可能减轻认知处理速度缓慢对 MS 患者功能结果的影响。
