Sandroff Brian M, Motl Robert W, Bamman Marcus, Cutter Gary R, Bolding Mark, Rinker John R, Wylie Glenn R, Genova Helen, DeLuca John
Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Department of Cell, Developmental and Integrative Biology, University of Alabama at Birmingham, Birmingham, Alabama, USA.
BMJ Open. 2018 Dec 14;8(12):e023231. doi: 10.1136/bmjopen-2018-023231.
This randomised controlled trial (RCT) examines treadmill walking exercise training effects on learning and memory performance, hippocampal volume, and hippocampal resting-state functional connectivity in persons with multiple sclerosis (MS) who have objective impairments in learning new information.
Forty fully ambulatory persons with MS who demonstrate objective learning and memory impairments will be randomly assigned into either the intervention or active control study conditions. The intervention condition involves supervised, progressive treadmill walking exercise training three times per week for a 3-month period. The active control condition involves supervised, progressive low-intensity resistive exercise that will be delivered at the same frequency as the intervention condition. The primary outcome will involve composite performance on neuropsychological learning and memory tests, and the secondary outcomes involve MRI measures of hippocampal volume and resting-state functional connectivity administered before and after the 3-month study period. Outcomes will be administered by treatment-blinded assessors using alternate test forms to minimise practice effects, and MRI data processing will be performed by blinded data analysts.
This study has been approved by a university institutional review board. The primary results will be disseminated via peer-reviewed publications and the final data will be made available to third parties in applicable data repositories. If successful, the results from this study will eventually inform subsequent RCTs for developing physical rehabilitation interventions (ie, treadmill walking exercise training) for improving learning and memory and its relationship with hippocampal outcomes in larger samples of cognitively impaired persons with MS. The results from this early-phase RCT will further lay preliminary groundwork for ultimately providing clinicians and patients with guidelines for better using chronic treadmill walking exercise for improving cognition and brain health. This approach is paramount as learning and memory impairment is common, burdensome and poorly managed in MS.
NCT03319771; Pre-results.
本随机对照试验（RCT）旨在研究跑步机步行运动训练对患有多发性硬化症（MS）且在学习新信息方面存在客观障碍的人群的学习与记忆表现、海马体体积以及海马体静息态功能连接的影响。
40名能够完全自主行走且存在客观学习与记忆障碍的MS患者将被随机分配至干预组或积极对照组。干预组每周接受3次有监督的、循序渐进的跑步机步行运动训练，为期3个月。积极对照组接受有监督的、循序渐进的低强度抗阻运动，训练频率与干预组相同。主要结局指标为神经心理学学习与记忆测试的综合表现，次要结局指标包括在3个月研究期前后进行的海马体体积和静息态功能连接的MRI测量。结局指标将由对治疗情况不知情的评估人员使用交替测试形式进行评估，以尽量减少练习效应，MRI数据处理将由不知情的数据分析人员进行。
本研究已获得一所大学机构审查委员会的批准。主要结果将通过同行评审出版物进行传播，最终数据将在适用的数据存储库中提供给第三方。如果研究成功，本研究结果最终将为后续的随机对照试验提供参考，以开发身体康复干预措施（即跑步机步行运动训练），用于改善更大样本的认知受损MS患者的学习与记忆及其与海马体结局的关系。这项早期随机对照试验的结果将进一步为最终为临床医生和患者提供更好地利用慢性跑步机步行运动改善认知和脑健康的指南奠定初步基础。鉴于学习与记忆障碍在MS中很常见、负担沉重且管理不善，这种方法至关重要。
NCT03319771；预结果。
