Clinical trial · Interventional
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Myasthenia Gravis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Generalized Myasthenia Gravis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Whole-body Electrical Muscle Stimulation Exercise | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Whole-body Electrical Muscle Stimulation (WB-EMS) Exercise
- description
- Participants with MG will receive the WB-EMS Exercise intervention 2 times per week for 4 weeks. Participants will only perform Level 1 exercise programs (simple movements) in the "Strength" Training Mode. These programs are 20-minute videos led by exercise professionals. They are full-body workouts. They consist of 10-12 exercises performed for 14 repetitions. Each repetition takes 4 seconds to complete (the time that the stimulation is "on") and is followed by a 4 second rest (the time that the stimulation is "off"). All exercises occur in a double-limb stance position. Most exercises occur with feet in wide base of support, hips width or more apart. All exercises are modifiable by the healthcare professional administering and monitoring the intervention based on participant's safe and available range of motion (i.e. arm movements, torso positions, extent of knee bend). Healthy Control participants will not complete the intervention.
- interventionNames
- Device: Whole-body Electrical Muscle Stimulation Exercise
Primary outcomes (3)
- measure
- Mean change from baseline in single fiber electromyography (SFEMG) jitter
- timeFrame
- Measured within 3 days of starting the intervention and within 3 days of completing the intervention
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria for Participants with MG: * Age 18 or older * Diagnosed with Generalized Myasthenia Gravis (gMG) via seropositive test for acetylcholine receptor (AChR) antibodies or seronegative test with clinical symptoms consistent with gMG * On stable MG therapy for at least 1 month * Ability to stand for approximately 15 minutes continuously with or without an assistive device (i.e. the length of time to stand to take a shower, complete meal preparation, wait in line at the bank, etc.) * Score of 1 (Mild) or 2 (Moderate) on at least one side of the "arm outstretched" and "leg outstretched" items of the QMG, demonstrating fatigability * At least some anti-gravity strength in major muscle groups as assessed by manual muscle testing (i.e. 2+/5 strength or better) * Medical clearance to participate in an exercise program * Ability to provide informed consent * Ability to conform to the requirements of the study (i.e. attendance at assessment and intervention visits, maintain current level of non-study physical activity for the duration of the study, no intention to relocate mid-study) Exclusion Criteria for Participants with MG: * Concurrent participation in another interventional research study * Unable to tolerate 15 minutes of continuous standing with or without an assistive device * Regular participation in strength training (2x per week or more over the past 6 months) * Score of 0 (None) on all "arm outstretched" and "leg outstretched" items of the QMG * Presence of a pacemaker, metal implants, or other implanted medical devices that could impact participant safety during WB-EMS intervention * Presence of unstable acute or chronic disease (i.e. renal failure, rheumatologic disease, cardia arrhythmia, neoplasm, uncontrolled hypertension) * Known pregnancy at time of screening * Presence of a terminal disease (i.e. receiving hospice services) * Current or previous use of any drugs known to influence muscle mass or performance within 6 months; these may include but are not limited to anabolic steroids, IGF01, growth hormone, replacement androgen therapy, anti-androgen therapy * Presence of an additional neuromuscular or neurologic condition affecting somatosensory or motor function/control (i.e. motor neuron disease, muscle disease, peripheral neuropathy, other NMJ condition, Parkinson's disease, Multiple Sclerosis, h/o stroke, traumatic brain injury, spinal cord injury, ataxia, apraxia, hemiplegia, etc.) * Musculoskeletal condition or surgery in the past year that would confound results of exercise interventions (i.e. knee replacement, hip replacement, rotator cuff repair, spinal fusion) * Other medical conditions, signs, or symptoms that would interfere with study conduct or interpretation of results as determined by an investigator Inclusion Criteria for Healthy Controls: * Age 18-39 years * Ability to provide informed consent Exclusion Criteria for Healthy Controls: * Concurrent participation in an interventional research study * Presence of unstable acute or chronic disease (i.e. renal failure, rheumatologic disease, cardia arrhythmia, neoplasm, uncontrolled hypertension) * Presence of a terminal disease (i.e. receiving hospice services) * Current or previous use of any drugs known to influence muscle mass or performance within 6 months; these may include but are not limited to anabolic steroids, IGF01, growth hormone, replacement androgen therapy, anti-androgen therapy * Presence of an additional neuromuscular or neurologic condition affecting somatosensory or motor function/control (i.e. motor neuron disease, muscle disease, peripheral neuropathy, other NMJ condition, Parkinson's disease, Multiple Sclerosis, h/o stroke, TBI, SCI, ataxia, apraxia, hemiplegia, etc.) * Musculoskeletal condition or surgery in the past year that would confound results of exercise interventions (i.e. TKA, THA, RTC repair, spinal fusion) * Other medical conditions, signs, or symptoms that would interfere with study conduct or interpretation of results as determined by an investigator Healthy controls will complete dEMG testing only during a one-time session.
References
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