Institute of Myology, Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.
Bioingénierie, Tissus et Neuroplasticité (BIOTN) EA 7377, University Paris-Est, UPEC, Créteil, France.
Trials. 2018 Jan 18;19(1):49. doi: 10.1186/s13063-017-2433-2.
Research exploring the effects of physical exercise in auto-immune myasthenia gravis (MG) is scarce. The few existing studies present methodological shortcomings limiting the conclusions and generalisability of results. It is hypothesised that exercise could have positive physical, psychological as well as immunomodulatory effects and may be a beneficial addition to current pharmacological management of this chronic disease. The aim of this study is to evaluate the benefits on perceived quality of life (QOL) and physical fitness of a home-based physical exercise program compared to usual care, for patients with stabilised, generalised auto-immune MG.
MGEX is a multi-centre, interventional, randomised, single-blind, two-arm parallel group, controlled trial. Forty-two patients will be recruited, aged 18-70 years. Following a three-month observation period, patients will be randomised into a control or experimental group. The experimental group will undertake a 40-min home-based physical exercise program using a rowing machine, three times a week for three months, as an add-on to usual care. The control group will receive usual care with no additional treatment. All patients will be followed up for a further three months. The primary outcome is the mean change in MGQOL-15-F score between three and six months (i.e. pre-intervention and immediately post-intervention periods). The MGQOL-15-F is an MG-specific patient-reported QOL questionnaire. Secondary outcomes include the evaluation of deficits and functional limitations via MG-specific clinical scores (Myasthenia Muscle Score and MG-Activities of Daily Living scale), muscle force and fatigue, respiratory function, free-living physical activity as well as evaluations of anxiety, depression, self-esteem and overall QOL with the WHO-QOL BREF questionnaire. Exercise workload will be assessed as well as multiple safety measures (ECG, biological markers, medication type and dosage and any disease exacerbation or crisis).
This is the largest randomised controlled trial to date evaluating the benefits and tolerance of physical exercise in this patient population. The comprehensive evaluations using standardised outcome measures should provide much awaited information for both patients and the scientific community. This study is ongoing.
ClinicalTrials.gov, NCT02066519 . Registered on 13 January 2014.
针对自身免疫性重症肌无力（MG）患者的身体锻炼效果的研究较为匮乏。为数不多的现有研究存在方法学缺陷，限制了结论和结果的普遍性。因此推测，运动可能具有积极的生理、心理和免疫调节作用，可能是目前对这种慢性疾病进行药物治疗的有益补充。本研究旨在评估与常规护理相比，针对病情稳定的全身性自身免疫性 MG 患者，家庭为基础的身体锻炼计划对感知生活质量（QOL）和身体适应性的益处。
MGEX 是一项多中心、干预性、随机、单盲、双臂平行组、对照临床试验。将招募 42 名年龄在 18-70 岁之间的患者。经过三个月的观察期后，患者将被随机分配到对照组或实验组。实验组将进行为期三个月的家庭为基础的划船机身体锻炼计划，每周三次，作为常规护理的附加治疗。对照组将接受常规护理，不进行额外治疗。所有患者将进一步随访三个月。主要结局是 MGQOL-15-F 评分在三个月至六个月之间的平均变化（即干预前和干预后即刻期间）。MGQOL-15-F 是一种针对 MG 的患者报告 QOL 问卷。次要结局包括通过 MG 特异性临床评分（肌无力评分和 MG 日常生活活动量表）评估缺陷和功能限制、肌肉力量和疲劳、呼吸功能、自由活动身体活动以及使用 WHO-QOL BREF 问卷评估焦虑、抑郁、自尊和整体 QOL。还将评估运动工作量以及多项安全措施（心电图、生物标志物、药物类型和剂量以及任何疾病恶化或危机）。
这是迄今为止评估该患者人群进行身体锻炼的益处和耐受性的最大随机对照试验。使用标准化结局测量的综合评估应该为患者和科学界提供急需的信息。本研究正在进行中。
ClinicalTrials.gov，NCT02066519。于 2014 年 1 月 13 日注册。
