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

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DataCite Commons2021-04-09 更新2024-07-28 收录
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https://karger.figshare.com/articles/dataset/Supplementary_Material_for_Rest_or_30-Min_Walk_as_Exercise_Intervention_RESTOREX_in_Myasthenia_Gravis_A_Randomized_Controlled_Trial/14392970
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<b><i>Introduction:</i></b> 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. <b><i>Methods:</i></b> 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 &gt;50% improvement in these outcome parameters. <b><i>Results:</i></b> 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 (<i>p =</i> 0.02). The secondary endpoints, distance covered in 6MWT (<i>p =</i> 0.007), were also better in the exercise arm without any adverse event. <b><i>Conclusion:</i></b> Regular exercise for 30 min in mild and moderate MG improves quality of life and walking distance compared to rest and is safe. <b><i>Clinical Trial Registration:</i></b> The clinical trial registration number is CTRI/2019/11/021869.

**引言:** 目前尚无关于运动或休息对重症肌无力(myasthenia gravis, MG)获益性的相关证据。本研究旨在评估运动或休息用于MG患者的有效性与安全性。 **方法:** 本研究为单中心开放标签随机对照试验,将轻中度MG患者随机分为两组,在标准治疗基础上分别接受30分钟步行运动或休息干预。本研究的主要终点为重症肌无力生活质量量表(MG Quality of Life, MG-QOL15)评分较基线改善≥50%的患者比例;次要终点包括重症肌无力肌肉评分(Myasthenic Muscle Score, MMS)、重症肌无力日常生活活动能力量表(MG Activities of Daily Living, MGADL)的变化,握力,乙酰胆碱酯酶抑制剂与泼尼松的给药剂量,6分钟步行试验(6-min walk test, 6MWT)步行距离,斜方肌低频重复神经电刺激试验的波幅递减情况,以及不良事件。所有结局指标的疗效判定均以3个月时上述参数较基线改善≥50%为标准。 **结果:** 本研究共纳入40例MG患者并随机分配至运动组与休息组。两组患者的人口学与临床基线特征匹配良好。运动组患者的生活质量显著优于休息组,表现为MG-QOL15评分更高(p=0.02)。次要终点方面,运动组的6分钟步行试验距离亦显著更长(p=0.007),且未观察到任何不良事件。 **结论:** 与休息干预相比,轻中度MG患者每日进行30分钟规律运动可显著改善生活质量与步行距离,且安全性良好。 **临床试验注册:** 本临床试验注册号为CTRI/2019/11/021869。
提供机构:
Karger Publishers
创建时间:
2021-04-09
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