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重症肌无力患者的休息或 30 分钟散步运动干预(RESTOREX):一项随机对照试验。

Rest or 30-Min Walk as Exercise Intervention (RESTOREX) in Myasthenia Gravis: A Randomized Controlled Trial.

机构信息

Department of Neurology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, India.

Department of Neurology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.

出版信息

Eur Neurol. 2021;84(3):168-174. doi: 10.1159/000513668. Epub 2021 Apr 9.

Abstract

INTRODUCTION

There is a lack of evidence about the usefulness of exercise or rest in myasthenia gravis (MG). This study is aimed to evaluate the efficacy and safety of exercise or rest in MG.

METHODS

In a single-center open-labeled randomized controlled trial, the patients with mild to moderate MG were randomized to 30-min walk or rest in addition to the standard treatment. The primary endpoint was 50% improvement in the MG Quality of Life (MG-QOL15), and secondary endpoints were change in the Myasthenic Muscle Score (MMS), MG Activities of Daily Living (MGADL), grip strength, dose of acetylcholine esterase inhibitor and prednisone, 6-min walk test (6MWT), decrement in trapezius on the low-rate repetitive nerve stimulation test, and adverse events. The outcomes were defined at 3 months, by >50% improvement in these outcome parameters.

RESULTS

Forty patients with MG were randomized to the exercise or rest arm. The 2 arms were matched for demographic and clinical parameters. The patients in the exercise arm had significantly better QOL evidenced by MG-QOL15 (p = 0.02). The secondary endpoints, distance covered in 6MWT (p = 0.007), were also better in the exercise arm without any adverse event.

CONCLUSION

Regular exercise for 30 min in mild and moderate MG improves quality of life and walking distance compared to rest and is safe.

CLINICAL TRIAL REGISTRATION

The clinical trial registration number is CTRI/2019/11/021869.

摘要

简介

肌无力(MG)患者在运动或休息方面的获益证据不足。本研究旨在评估运动或休息对 MG 的疗效和安全性。

方法

在一项单中心开放标签随机对照试验中,将轻度至中度 MG 患者随机分为运动组(额外进行 30 分钟步行)和休息组(额外休息),同时接受标准治疗。主要终点为 MG 生活质量量表(MG-QOL15)的 50%改善,次要终点为肌无力肌评分(MMS)、MG 日常生活活动能力(MGADL)、握力、乙酰胆碱酯酶抑制剂和泼尼松剂量、6 分钟步行试验(6MWT)、低频重复神经刺激试验中斜方肌递减、不良事件的变化。3 个月时,通过这些终点参数的>50%改善来定义结果。

结果

40 例 MG 患者被随机分配到运动或休息组。两组的人口统计学和临床参数相匹配。运动组患者的生活质量明显改善,表现在 MG-QOL15 评分上(p=0.02)。次要终点,6MWT 中覆盖的距离(p=0.007),在运动组也更好,且无不良事件。

结论

与休息相比,在轻度和中度 MG 中进行 30 分钟的常规运动可改善生活质量和行走距离,且安全。

临床试验注册

临床试验注册号是 CTRI/2019/11/021869。

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