Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Myasthenia Gravis

Not Applicable

Recruiting

• Conditions: Generalized Myasthenia Gravis

• Registration Number: NCT06064695
• Lead Sponsor: University of Missouri-Columbia

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-07-12
• Study First Submitted: 2023-09-26
• Study First Submitted QC: 2023-09-26
• Study First Posted: 2023-10-03
• Status Verified: 2025-04
• Primary Completion: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-10
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in single fiber electromyography (SFEMG) jitter	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)	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)	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

Secondary Outcome Measures

Name	Time	Method
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	Decomposition electromyography (dEMG) is a measurement of motor unit activity; a surface electrode will be placed over the vastus lateralis in the thigh and participants will be asked to activate that muscle
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	Decomposition electromyography (dEMG) is a measurement of motor unit activity; a surface electrode will be placed over the middle deltoid in the shoulder and participants will be asked to activate that muscle
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	Quantitative Myasthenia Gravis (QMG) is a measure of overall disease severity; items include eye movements, swallowing, speaking, breathing test, grip strength, and neck/arm/leg endurance. Thirteen items will be rated on a scale of 0-3 where higher scores indicated greater disease severity.
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	Fatigue Severity Scale (FSS) is a patient-reported outcome measure assessing the impact of perceived fatigue on a person's life over the prior 7-day period. Nine items are rated on a scale of 1-7 where higher scores indicate more impact of perceived fatigue.

Trial Locations

Locations (2)

University of Kansas Clinical Research Center; 🇺🇸 Fairway, Kansas, United States

NextGen Precision Health Building, Clinical and Translational Science Unit; 🇺🇸 Columbia, Missouri, United States