Department of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Brazil
Laboratory of Technological Innovation in Health, Federal University of Rio Grande do Norte, Natal, Brazil.
BMJ Open. 2022 May 26;12(5):e056323. doi: 10.1136/bmjopen-2021-056323.
Amyotrophic Lateral Sclerosis (ALS) is a progressive neurodegenerative disease with variable and complex clinical manifestations that requires a multidisciplinary approach. However, face-to-face treatment in this population may experience barriers, such as difficulty accessing physical therapists or other professionals. As a result, strategies (eg, telerehabilitation) emerged to facilitate treatment and physical therapy monitoring. This study aims to evaluate the effects of remote versus face-to-face home-based exercise programmes on clinical outcomes and treatment adherence of people with ALS.
This is a single-blind randomised clinical trial protocol that will include 44 people with clinical diagnosis of ALS at any clinical stage and aged between 18 and 80 years. Participants will be randomised into two groups after face-to-face evaluation and perform a home-based exercise programme three times a week for 6 months. A physical therapist will monitor the exercise programme once a week remotely (phone calls-experimental group) or face-to-face (home visits-control group). The primary outcome measure will be functional capacity (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised). Secondary outcomes will include disease severity (Amyotrophic Lateral Sclerosis Severity Scale), fatigue (Fatigue Severity Scale), pain (Visual Analogue Scale and body pain diagram), adverse events and adherence rate. Outcomes will be initially evaluated face-to-face and revaluated remotely every 2 months and 1 month after interventions. Linear mixed models will compare outcome measures between groups and evaluations (α=5%).
This study was approved by the research ethics committee of Hospital Universitário Onofre Lopes/Universidade Federal do Rio Grande do Norte (no. 3735479). We expect to identify the effects of an exercise programme developed according to ALS stages and associated with remote or face-to-face monitoring on clinical outcomes using revaluations and follow-up after interventions.
Brazilian Registry Clinical Trials (RBR-10z9pgfv).
肌萎缩侧索硬化症（ALS）是一种进行性神经退行性疾病，具有多变且复杂的临床表现，需要多学科的方法。然而，在这种人群中进行面对面的治疗可能会遇到障碍，例如难以获得物理治疗师或其他专业人员的帮助。因此，出现了一些策略（例如远程康复）来促进治疗和物理治疗的监测。本研究旨在评估远程和面对面家庭为基础的运动方案对肌萎缩侧索硬化症患者的临床结果和治疗依从性的影响。
这是一项单盲随机临床试验方案，将包括 44 名处于任何临床阶段的临床诊断为肌萎缩侧索硬化症的患者，年龄在 18 至 80 岁之间。参与者将在面对面评估后进行随机分组，并进行每周三次、为期 6 个月的家庭为基础的运动方案。一名物理治疗师将每周远程（电话-实验组）或面对面（家访-对照组）一次监测运动方案。主要结局指标将是功能能力（肌萎缩侧索硬化症功能评定量表修订版）。次要结局指标将包括疾病严重程度（肌萎缩侧索硬化症严重程度量表）、疲劳（疲劳严重程度量表）、疼痛（视觉模拟量表和身体疼痛图）、不良事件和依从率。结果将首先面对面评估，并在干预后每 2 个月和 1 个月远程重新评估。线性混合模型将比较组间和评估间的结局测量（α=5%）。
本研究得到了奥诺弗雷洛佩斯大学医院/北里奥格兰德州联邦大学研究伦理委员会的批准（编号 3735479）。我们预计将确定根据肌萎缩侧索硬化症的阶段制定的运动方案的效果，并结合远程或面对面监测对临床结果的影响，使用重新评估和干预后随访来进行评估。
巴西临床研究注册（RBR-10z9pgfv）。
