Electrical Muscle Stimulation Exercise for Myasthenia Gravis

Recruiting at 2 trial locations

Overseen By W. David Arnold, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Missouri-Columbia

Must not be taking: Anabolic steroids, Growth hormone

Disqualifiers: Unstable disease, Neurologic condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 4 weeks

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether exercising with electrical muscle stimulation can reduce fatigue and improve muscle function in people with Generalized Myasthenia Gravis (gMG), a condition that causes muscle weakness and fatigue. Participants will perform exercises using electrical muscle stimulation twice a week for four weeks. The trial seeks individuals with gMG who can stand for 15 minutes, such as when showering or preparing a meal, and have some muscle strength.

As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance the quality of life for those with gMG.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be on stable Myasthenia Gravis therapy for at least 1 month before joining the study.

What prior data suggests that this exercise protocol is safe for individuals with Myasthenia Gravis?

Research has shown that whole-body electrical muscle stimulation (WB-EMS) is generally safe and well-tolerated. Studies have found this exercise method safe even for frail older adults. Importantly, no reports indicated serious muscle damage, such as exertional rhabdomyolysis, where muscles break down quickly. Instead, WB-EMS provides enough intensity to be effective without causing harm. Overall, based on current evidence, this treatment appears safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of whole-body Electrical Muscle Stimulation (WB-EMS) exercise for treating Myasthenia Gravis because it offers a non-invasive, innovative approach to enhancing muscle strength and endurance. Unlike traditional treatments that often involve medication or surgery, WB-EMS directly stimulates muscles through electrical impulses, potentially improving muscle function more naturally and safely. This method allows for personalized exercise programs tailored to the individual's capabilities, providing a flexible and adaptive treatment option that might improve quality of life for patients with Myasthenia Gravis.

What evidence suggests that whole-body electrical muscle stimulation exercise is effective for myasthenia gravis?

Research has shown that whole-body electrical muscle stimulation exercise (WB-EMS), which participants in this trial will receive, might improve muscle strength and reduce tiredness. Studies have found that WB-EMS can significantly boost muscle strength in older adults, suggesting it could also benefit people with generalized myasthenia gravis (gMG). This method targets the connection between nerves and muscles, often affected in gMG. Early findings suggest that WB-EMS might enhance muscle response to nerve signals, possibly reducing tiredness in those affected. While more research is needed, these initial results offer promise for those seeking relief from gMG symptoms. ^{1 2 3 4 6}

Who Is on the Research Team?

Kristina M Kelly, DPT

Principal Investigator

University of Missouri-Columbia

Are You a Good Fit for This Trial?

Adults with Generalized Myasthenia Gravis who've been on stable MG therapy for at least a year, can stand for about 15 minutes, and have mild to moderate muscle weakness. They should not be in other studies, have certain medical conditions or implants that affect safety during the exercise, or be doing regular strength training.

Inclusion Criteria

I have been on a consistent treatment for myasthenia gravis for at least 1 year.

I have been diagnosed with Generalized Myasthenia Gravis.

I experience mild to moderate weakness when holding my arm or leg out.

Exclusion Criteria

Other medical conditions, signs, or symptoms that would interfere with study conduct or interpretation of results as determined by an investigator

I have tested positive for MuSK or LRP4 antibodies.

I do not have any unstable illnesses like kidney failure or uncontrolled high blood pressure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive whole-body electrical muscle stimulation exercise (WB-EMS Exercise) intervention 2 times per week for 4 weeks

4 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up (optional)

Participants may opt into long-term follow-up to assess sustained effects of the intervention

What Are the Treatments Tested in This Trial?

Interventions

• Whole-body Electrical Muscle Stimulation Exercise

Trial Overview

The trial is testing if Whole-body Electrical Muscle Stimulation Exercise (WB-EMS) can improve muscle communication and reduce fatigue in adults with Myasthenia Gravis. Participants will do WB-EMS twice weekly for four weeks while their neuromuscular function is monitored.

How Is the Trial Designed?

Group I: Whole-body Electrical Muscle Stimulation (WB-EMS) Exercise Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

University of Kansas Medical Center

Collaborator

Trials

527

Recruited

181,000+

Published Research Related to This Trial

A systematic review of 21 studies involving 505 participants found that while whole-body electrical myostimulation (WB-EMS) is popular, there is insufficient scientific evidence to definitively conclude its effectiveness for various training outcomes.

Most studies analyzed the chronic effects of WB-EMS, but many had a moderate to high risk of bias, highlighting the need for more rigorous randomized controlled trials to better understand its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of whole-body ELECTROMYOSTIMULATION on health and performance: a systematic review. Pano-Rodriguez, A., Beltran-Garrido, JV., Hernández-González, V., et al.[2023]

Whole Body Electromyostimulation (WB-EMS) is a growing area of research, particularly in Germany, which leads in scientific publications on this training methodology.

The study identified Wolfgang Kemmler as a key author in WB-EMS research, highlighting the increasing interest and collaboration among researchers, especially from Germany and Spain, in exploring this innovative training technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bibliometric Analysis of Studies on Whole Body Electromyostimulation. Rodrigues-Santana, L., Adsuar, JC., Denche-Zamorano, Á., et al.[2022]

Whole-body electromyostimulation (WB-EMS) significantly reduces sarcopenia and improves muscle strength in older adults, with large effect sizes observed in reducing sarcopenia Z-scores and improving leg extensor strength over medium to long-term periods.

WB-EMS also shows moderate improvements in handgrip strength and gait speed, but does not significantly affect waist circumference or triglyceride levels, indicating its specific benefits for muscle health rather than metabolic parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of whole-body electromyostimulation on health indicators of older people: Systematic review and meta-analysis of randomized trials. de Oliveira, TMD., Felício, DC., Filho, JE., et al.[2022]

A study involving 22 participants compared the effects of two different whole-body electrostimulation (WB-EMS) training modalities with a traditional resistance training program over 6 weeks, and all groups showed significant improvements in strength and muscle power.

No significant differences in effectiveness were found between the WB-EMS and resistance training groups, suggesting that WB-EMS can be a valid alternative or complement to traditional strength training methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Two Modalities of Whole-body Electrostimulation Programs and Resistance Circuit Training on Strength and Power. DʼOttavio, S., Briotti, G., Rosazza, C., et al.[2019]

Whole-body electromyostimulation (WB-EMS) was effective in increasing lean body mass by 1.5% and grip strength by 8.4% in a study of 76 osteopenic women aged 70 and older over one year.

While WB-EMS showed borderline improvements in bone mineral density at the lumbar spine compared to a control group, the effects on bone density were less pronounced than the improvements in muscle strength and mass, suggesting it may be a suitable option for those unable to engage in intense exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-Body Electromyostimulation to Fight Osteopenia in Elderly Females: The Randomized Controlled Training and Electrostimulation Trial (TEST-III). von Stengel, S., Bebenek, M., Engelke, K., et al.[2022]

A strength training program over ten weeks for 11 patients with mild to moderate myasthenia gravis resulted in a significant 23% increase in maximal voluntary muscle force in knee extension on the trained side, compared to only 4% on the untrained side.

The training was safe, with no adverse effects reported on the patients' myasthenia gravis, indicating that physical training can be beneficial for improving muscle strength in individuals with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical training effects in myasthenia gravis. Lohi, EL., Lindberg, C., Andersen, O.[2006]

In patients with Lambert-Eaton myasthenic syndrome (LEMS), maximum voluntary contraction leads to greater increases in compound motor action potential (CMAP) amplitude and area compared to 20-Hz repetitive nerve stimulation, making it a more effective and less painful testing method.

While both CMAP area and amplitude can show abnormal potentiation in LEMS patients, measuring CMAP amplitude is equally effective and simpler, and testing a single hand muscle may not capture the full extent of abnormal potentiation in all LEMS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive nerve stimulation studies in the Lambert-Eaton myasthenic syndrome. Tim, RW., Sanders, DB.[2008]

In a study involving 14 patients with Lambert-Eaton myasthenic syndrome (LEMS), post-exercise exhaustion was assessed through repetitive nerve stimulation tests, revealing a significant initial increase in muscle response immediately after exercise (377% increase in CMAP amplitude).

However, this was followed by a notable decline in muscle response, with the most severe decrement observed 2 minutes post-exercise (-50%), indicating that exercise leads to reversible myasthenic fatigue in LEMS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-exercise exhaustion in Lambert-Eaton myasthenic syndrome. Oh, SJ., Hatanaka, Y., Ito, E., et al.[2019]

Whole-Body Electromyostimulation (WB-EMS) is a time-efficient and joint-friendly training method that stimulates all major muscle groups simultaneously, making it suitable for individuals who may struggle with traditional exercise.

To enhance the safety and effectiveness of WB-EMS, updated guidelines emphasize the importance of qualified trainers, thorough participant assessments, and close supervision during sessions, addressing previous concerns about adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Position statement and updated international guideline for safe and effective whole-body electromyostimulation training-the need for common sense in WB-EMS application. Kemmler, W., Fröhlich, M., Ludwig, O., et al.[2023]

Whole-body electro-myo-stimulation (WB-EMS) can lead to elevated creatine-kinase (CK) levels and has been associated with cases of rhabdomyolysis, although it is unclear if WB-EMS was the sole cause in these instances.

Current research lacks comprehensive data on the safety and contraindications of WB-EMS, particularly regarding muscle damage and risk factors for rhabdomyolysis, highlighting the need for better regulation and physician screening before use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side effects of and contraindications for whole-body electro-myo-stimulation: a viewpoint. Stöllberger, C., Finsterer, J.[2020]

In a study of 46 patients with myasthenia gravis, significant decrements in muscle response were consistently associated with increased jitter and impulse blocking detected by single-fiber electromyography (SFEMG).

SFEMG proved to be more sensitive than repetitive nerve stimulation (RNS) in identifying neuromuscular transmission disorders, as it could detect impulse blocking and increased jitter even when RNS results were normal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single fiber EMG and repetitive stimulation of the same muscle in myasthenia gravis. Gilchrist, JM., Massey, JM., Sanders, DB.[2004]

Whole-body electro-myo-stimulation (WB-EMS) has been associated with significant increases in creatine kinase (CK) levels, indicating potential muscle damage, and has led to cases of rhabdomyolysis, particularly after initial sessions.

The safety of WB-EMS is questionable, as many participants reported muscular discomfort, and there are no clear contraindications, suggesting that individuals with a history of muscle disorders should avoid this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side effects of whole-body electro-myo-stimulation. Stöllberger, C., Finsterer, J.[2020]

A tailored exercise program in a gym setting was safely implemented for seven patients with generalized myasthenia gravis (MG), showing improvements in aerobic capacity, muscle strength, and balance.

This study suggests that well-controlled MG patients can benefit from personalized training in the community, paving the way for broader access to exercise interventions for MG management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of tailored exercise programs for MG patients in a gym setting: a pragmatic feasibility case study. Punga, AR., Westerberg, E., Åsenlöf, P.[2023]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06064695?term=nmj&viewType=Table&rank=6

Effects of Whole-body Electrical Muscle Stimulation ...

At the conclusion of the study, expected outcomes include: (1) preliminary data regarding the efficacy of WB-EMS Exercise to address fatigability, (2) an ...

2.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06064695/effects-of-whole-body-electrical-muscle-stimulation-exercise-on-adults-with-myasthenia-gravis

Effects of Whole-body Electrical Muscle Stimulation ...

During this pilot study, the investigators will examine the effects of whole-body electrical muscle stimulation exercise (WB-EMS Exercise) ...

3.

clinicaltrial.be

clinicaltrial.be/en/details/281560?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Effects of Whole-body Electrical Muscle Stimulation Exerc...

At the conclusion of the study, expected outcomes include: (1) preliminary data regarding the efficacy of WB-EMS Exercise to address ...

4.

careacross.com

careacross.com/clinical-trials/trial/NCT06064695

Effects of Whole-body Electrical Muscle Stimulation ...

The WB-EMS Exercise intervention will be delivered 2 times per week for 4 weeks. The hypotheses are (a) that the WB-EMS exercise will improve fatigability and ...

5.

withpower.com

withpower.com/trial/phase-myasthenia-gravis-6-2023-7061d

Electrical Muscle Stimulation Exercise for Myasthenia Gravis

Whole-body electromyostimulation (WB-EMS) significantly reduces sarcopenia and improves muscle strength in older adults, with large effect sizes observed in ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9263209/

Feasibility and Safety of Whole-Body ...

WB-EMS is feasible for frail older people. There were no clinical signs of exertional rhabdomyolysis. WB-EMS proved to be sufficiently intense ...