Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Myasthenia Gravis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Mean change from baseline in single fiber electromyography (SFEMG) jitter
研究概览
简要总结
During this pilot study, the investigators will examine the effects of whole-body electrical muscle stimulation exercise (WB-EMS Exercise) on neuromuscular junction (NMJ) transmission and fatigability in adults with Generalized Myasthenia Gravis (gMG). The investigators will also test whether a relationship exists between NMJ transmission dysfunction and fatigability in gMG, which has long been presumed but never directly assessed. Participants will undergo clinical and electrophysiologic testing before and after the WB-EMS Exercise intervention. The WB-EMS Exercise intervention will be delivered 2 times per week for 4 weeks. Long-term follow up is optional. The hypotheses are (a) that the WB-EMS exercise will improve fatigability and NMJ transmission, and (b) that NMJ transmission dysfunction is related to fatigability.
详细描述
During this pilot study, the investigators will examine the effects of a novel paradigm, whole-body electrical muscle stimulation exercise (WB-EMS Exercise), on neuromuscular junction (NMJ) transmission and fatigability in adults with Generalized Myasthenia Gravis (gMG). The investigators will also test whether a relationship exists between NMJ transmission dysfunction and fatigability in gMG, which has long been presumed but never directly assessed. The investigators will use single fiber electromyography (SFEMG) to capture pre- and post-treatment jitter, which measures NMJ transmission variability. The investigators will use decomposition electromyography and clinical measures to assess pre- and posttreatment fatigability of motor units and muscles. and associate these with baseline values for NMJ transmission to determine the relationship between these variables. At the conclusion of the study, expected outcomes include: (1) preliminary data regarding the efficacy of WB-EMS Exercise to address fatigability, (2) an indication of whether this type of exercise may promote NMJ remodeling, and (3) clarification of mechanistic connections between NMJ transmission and fatigability. These findings will provide new insights into mechanisms of fatigability and responses to exercise in gMG. The long-term goal is to define the effects of exercise on gMG pathophysiology and identify effective and tolerable modes of exercise that can be recommended to manage and prevent gMG-related fatigue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Mean change from baseline in single fiber electromyography (SFEMG) jitter
时间窗: Measured within 3 days of starting the intervention and within 3 days of completing the intervention
Single fiber electromyography (SFEMG) jitter is a measure of neuromuscular junction transmission variability; a small needle will be inserted into one of the quadriceps muscles to obtain the measurement
Mean change from baseline in the linear change in performance during the arm movement test (AMT)
时间窗: Measured within 3 days of starting the intervention and within 3 days of completing the intervention
Arm Movement Test (AMT) is a measure of upper extremity muscle fatigability; participants will move their arm back and forth between 2 targets as many times as they can in 90 seconds
Mean change from baseline in the linear change in performance during the six-minute walk test (6MWT)
时间窗: Measured within 3 days of starting the intervention and within 3 days of completing the intervention
Six-minute Walk Test (6MWT) is a measure of endurance and muscle fatigability; participants will walk as far as they can in 6 minutes
次要结局
- Mean change from baseline in motor unit firing rates of the vastus lateralis using decomposition electromyography (dEMG)(Measured within 3 days of starting the intervention and within 3 days of completing the intervention)
- Mean change from baseline in motor unit firing rates of the middle deltoid using decomposition electromyography (dEMG)(Measured within 3 days of starting the intervention and within 3 days of completing the intervention)
- Mean change from baseline in the quantitative myasthenia gravis (QMG) score(Measured within 3 days of starting the intervention and within 3 days of completing the intervention)
- Mean change from baseline in fatigue severity scale (FSS)(Measured within 3 days of starting the intervention and within 3 days of completing the intervention)
研究者
Kristina Kelly
Assistant Research Professor
University of Missouri-Columbia