Department of Physiotherapy, College of Health Sciences, University of Sharjah, Sharjah, United Arab Emirates.
Faculty of Physical Therapy, Cairo University, Giza, Egypt.
PLoS One. 2021 Nov 8;16(11):e0258752. doi: 10.1371/journal.pone.0258752. eCollection 2021.
Fatigue is considered one of the most common symptoms of multiple sclerosis (MS) and lacks a current standardized treatment. Therefore, the aim of this study was to examine the feasibility and effectiveness of a cognition-targeted exercise versus symptom-targeted exercise for MS fatigue.
In this Pilot, parallel-group, randomized controlled trial, sixty participants with multiple sclerosis, were randomly assigned to either a Cognition-Targeted Exercise (CTE) (N = 30, mean age 41) or a Symptom-Targeted Exercise (STE) (N = 30, mean age 42). The participants in the experimental group received eight, 50-minute sessions of weekly Cognitive Behavior Therapy (CBT) in addition to a CTE Program; whereas, participants in the control group received eight, 50-minute sessions of weekly CBT in addition to the standardized physiotherapy program (STE Program). Feasibility was assessed through recruitment rate, participant retention, adherence and safety, in addition to clinical outcome measures, including: (1) Modified Fatigue Impact Scale (MFIS), (2) Work and Social Adjustment Scale (WSAS), (3) Hospital Anxiety and Depression Scale (HADS), and Perceived Stress Scale (PSS). All outcome measures were assessed at baseline (pretreatment), following completion of the eight visit intervention protocol, and at 3-months follow-up.
The recruitment rate was 60% and 93% of participants completed the entire study. The recruited participants complied with 98% of the required visits. No adverse events were recorded. A Generalized Estimation Equation Model revealed a significant difference over time as an interaction term during the post and follow up visit for all clinical outcome measures (p < .001).
The addition of CTE to CBT exhibited positive and more lasting influence on MS fatigue outcomes compared to Symptom-Targeted Exercise (STE). Feasibility and efficacy data from this pilot study provide support for a full-scale RCT of CTE as an integral component of Multiple Sclerosis fatigue management.
疲劳被认为是多发性硬化症（MS）最常见的症状之一，目前缺乏标准化的治疗方法。因此，本研究旨在探讨针对 MS 疲劳的认知靶向运动与症状靶向运动的可行性和有效性。
在这项初步研究中，采用平行组随机对照试验，将 60 名多发性硬化症患者随机分为认知靶向运动（CTE）组（n = 30，平均年龄 41 岁）或症状靶向运动（STE）组（n = 30，平均年龄 42 岁）。实验组患者每周接受 8 次 50 分钟的认知行为疗法（CBT），外加 CTE 方案；对照组患者每周接受 8 次 50 分钟的 CBT，外加标准化的物理治疗方案（STE 方案）。通过招募率、参与者保留率、依从性和安全性，以及临床结果测量，包括（1）改良疲劳影响量表（MFIS），（2）工作和社会适应量表（WSAS），（3）医院焦虑和抑郁量表（HADS）和感知压力量表（PSS）来评估可行性。所有结果测量均在基线（治疗前）、完成 8 次访视干预方案后和 3 个月随访时进行评估。
招募率为 60%，93%的参与者完成了整个研究。招募的参与者完成了 98%的规定访视。没有记录到不良事件。广义估计方程模型显示，在所有临床结果测量中，随着时间的推移，在随访期间有显著的差异，这是一个交互项（p<.001）。
与症状靶向运动（STE）相比，CBT 加 CTE 对 MS 疲劳结果有积极和更持久的影响。这项初步研究的可行性和疗效数据为 CTE 作为多发性硬化症疲劳管理的一个组成部分的全面 RCT 提供了支持。
