Wender Carly L A, Arbelaez Odalys, Tong Tien T, Salter Amber, Wylie Glenn R, Motl Robert W, Sandroff Brian M, Chiaravalloti Nancy D
Center for Neuropsychology & Neuroscience Research, Kessler Foundation, East Hanover, NJ, USA; Department of Physical Medicine and Rehabilitation, Rutgers-NJ Medical School, Newark, NJ, USA.
Center for Neuropsychology & Neuroscience Research, Kessler Foundation, East Hanover, NJ, USA.
Contemp Clin Trials. 2024 Sep;144:107630. doi: 10.1016/j.cct.2024.107630. Epub 2024 Jul 13.
This paper describes the protocol for a Phase I/II, parallel-group, single-blind randomized controlled trial (RCT). The RCT investigates the combined effects of 12-weeks of aerobic exercise training (AET) integrated with virtual reality (VR) and cognitive rehabilitation (CR) on new learning and memory in 78 persons with multiple sclerosis (MS) who have mobility disability and objective impairments in learning and memory.
Participants will undergo baseline assessments consisting of neuropsychological testing, neuroimaging, self-report questionnaires, and cardiorespiratory fitness. Participants will then be randomized into one of two conditions using concealed allocation: aerobic cycling exercise that incorporates VR combined with CR or stretching and toning (i.e., active control; S/T) combined with CR. Participants will be masked regarding the intent of the conditions. After 7-weeks of exercise alone, the 5-week Kessler Foundation modified Story Memory Technique (KF-mSMT®) will be integrated into the training. After the 12-week training period, participants will complete the same measures as at baseline administered by treatment-blinded assessors. Primary study outcomes include new learning and memory (NLM) measured by a small battery of neuropsychological assessments that assess list learning (California Verbal Learning Test-II), prose memory (Memory Assessment Scale), visuospatial memory (Brief Visuospatial Memory Test-Revised), and everyday memory (Ecological Memory Simulations). Secondary study outcomes include neuroimaging outcomes of hippocampal structure, function, and connectivity.
If successful, this trial will provide the first Class I evidence supporting the unique combination of aerobic cycling exercise with VR and CR for treating MS-related learning and memory impairments in persons with mobility disability.
本文描述了一项I/II期平行组单盲随机对照试验（RCT）的方案。该RCT研究了为期12周的有氧运动训练（AET）与虚拟现实（VR）及认知康复（CR）相结合，对78名患有多发性硬化症（MS）且有行动障碍以及存在学习和记忆客观损伤的患者的新学习和记忆能力的综合影响。
参与者将接受包括神经心理学测试、神经影像学检查、自我报告问卷和心肺适能的基线评估。然后，参与者将通过隐蔽分配随机分为两种情况之一：结合VR和CR的有氧骑行运动，或结合CR的伸展和塑形运动（即积极对照；S/T）。参与者将对分组意图不知情。在单独进行7周运动后，为期5周的凯斯勒基金会改良故事记忆技术（KF-mSMT®）将被纳入训练。在为期12周的训练期结束后，参与者将由对治疗不知情的评估者完成与基线相同的测量。主要研究结果包括通过一小套神经心理学评估来测量的新学习和记忆（NLM），这些评估包括列表学习（加利福尼亚言语学习测试-II）、散文记忆（记忆评估量表）、视觉空间记忆（简明视觉空间记忆测试-修订版）和日常记忆（生态记忆模拟）。次要研究结果包括海马体结构、功能和连通性的神经影像学结果。
如果试验成功，将提供首个I类证据，支持将有氧骑行运动与VR和CR独特结合，用于治疗有行动障碍的MS患者的与MS相关的学习和记忆损伤。
