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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Whole-body Electrical Muscle Stimulation Exercise for Myasthenia Gravis?

Research shows that whole-body electrical muscle stimulation (WB-EMS) can improve muscle strength and mass, particularly in older adults, and may serve as a complementary or alternative method to traditional resistance training. While specific data for Myasthenia Gravis is not available, these findings suggest potential benefits for muscle-related conditions. ^{1 2 3 4 5}

Is whole-body electrical muscle stimulation exercise safe for humans?

Whole-body electrical muscle stimulation (WB-EMS) can have side effects, such as muscle discomfort and elevated creatine kinase levels, which may indicate muscle damage. There have been reports of a serious condition called rhabdomyolysis (muscle breakdown) in some cases, especially after the first use. Proper supervision, trainer qualifications, and participant preparation are important to increase safety. ^{1 5 6 7 8}

How is the Whole-body Electrical Muscle Stimulation Exercise treatment different from other treatments for myasthenia gravis?

Whole-body Electrical Muscle Stimulation Exercise is unique because it uses electrical impulses to stimulate muscles, potentially improving muscle strength and reducing fatigue without the need for traditional physical exercise. This approach may offer a novel way to enhance muscle function in myasthenia gravis patients, compared to standard exercise programs that require voluntary muscle contractions. ^{9 10 11 12 13}

Research Team

Kristina M Kelly, DPT

Principal Investigator

University of Missouri-Columbia

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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) 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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effects of whole-body ELECTROMYOSTIMULATION on health and performance: a systematic review. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Bibliometric Analysis of Studies on Whole Body Electromyostimulation. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of whole-body electromyostimulation on health indicators of older people: Systematic review and meta-analysis of randomized trials. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Effects of Two Modalities of Whole-body Electrostimulation Programs and Resistance Circuit Training on Strength and Power. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Whole-Body Electromyostimulation to Fight Osteopenia in Elderly Females: The Randomized Controlled Training and Electrostimulation Trial (TEST-III). [2022]

6. Switzerland 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. [2023]

7. Austria pubmed.ncbi.nlm.nih.gov

Side effects of whole-body electro-myo-stimulation. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Side effects of and contraindications for whole-body electro-myo-stimulation: a viewpoint. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Physical training effects in myasthenia gravis. [2006]

10. United States pubmed.ncbi.nlm.nih.gov

Repetitive nerve stimulation studies in the Lambert-Eaton myasthenic syndrome. [2008]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Post-exercise exhaustion in Lambert-Eaton myasthenic syndrome. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Single fiber EMG and repetitive stimulation of the same muscle in myasthenia gravis. [2004]

13. England pubmed.ncbi.nlm.nih.gov

Implementation of tailored exercise programs for MG patients in a gym setting: a pragmatic feasibility case study. [2023]