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Home-based exercise in autoimmune myasthenia gravis: A randomized controlled trial
Neuromuscular Disorders ( IF 2.7 ) Pub Date : 2021-05-27 , DOI: 10.1016/j.nmd.2021.05.002
S Birnbaum 1 , R Porcher 2 , P Portero 3 , B Clair 4 , S Demeret 4 , B Eymard 5 , M Gargiulo 1 , E Louët 1 , S Berrih-Aknin 1 , R Le Panse 5 , P Aegerter 4 , J Y Hogrel 1 , T Sharshar 6 ,
Affiliation  

The tolerance of exercise and its effects on quality of life in myasthenia gravis are not currently backed up by strong evidence. The aim of this study was to determine whether exercise as an adjunct therapy is well tolerated and can improve health-related quality of life (HRQoL) in stabilized, generalized autoimmune myasthenia gravis (gMG). We conducted a parallel-group, multi-center prospective RCT using computer-generated block randomization. Adults with stabilized, gMG, and no contra-indication to exercise, were eligible. Participants received usual care alone or usual care and exercise. The exercise intervention consisted of 3-weekly 40 min sessions of an unsupervised, moderate-intensity home rowing program over 3 months. The primary endpoint was the change in HRQoL from randomization to post-intervention. Assessor-blinded secondary endpoints were exercise tolerance and effects on clinical, psychological and immunological status. Of 138 patients screened between October 2014 and July 2017, 45 were randomly assigned to exercise (n = 23) or usual care (n = 20). Although exercise was well tolerated, the intention-to-treat analysis revealed no evidence of improved HRQoL compared to usual care (MGQOL-15-F; mean adjusted between-groups difference of -0.8 points, 95%CI -5.4 to 3.7). Two patients hospitalized for MG exacerbation were from the usual care group.



中文翻译:

自身免疫性重症肌无力的家庭运动:一项随机对照试验

目前没有强有力的证据支持运动的耐受性及其对重症肌无力患者生活质量的影响。本研究的目的是确定运动作为一种辅助疗法是否具有良好的耐受性,是否可以改善稳定的全身性自身免疫性重症肌无力 (gMG) 的健康相关生活质量 (HRQoL)。我们使用计算机生成的随机分组进行了平行组、多中心前瞻性随机对照试验。具有稳定、gMG 且没有运动禁忌症的成人符合条件。参与者单独接受常规护理或常规护理和锻炼。运动干预包括为期 3 个月、每次 40 分钟的无人监督、中等强度的家庭划船计划,为期 3 个月。主要终点是 HRQoL 从随机化到干预后的变化。评估者不知情的次要终点是运动耐力和对临床、心理和免疫状态的影响。在 2014 年 10 月至 2017 年 7 月期间筛查的 138 名患者中,45 名被随机分配到运动组(n  = 23) 或常规护理 ( n  = 20)。尽管运动耐受性良好,但意向治疗分析显示,与常规护理相比,没有证据表明 HRQoL 有所改善(MGQOL-15-F;平均调整组间差异为 -0.8 分,95% CI -5.4 至 3.7)。两名因 MG 恶化住院的患者来自常规护理组。

更新日期:2021-05-27
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