Electrical Muscle Stimulation Exercise for Myasthenia Gravis
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Missouri-Columbia
Must not be taking: Anabolic steroids, Growth hormone
Disqualifiers: Unstable disease, Neurologic condition, others
No Placebo Group
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.12345
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.15678
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.910111213
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.
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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.
See 10 more
Trial 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 (Behavioural Intervention)
Trial OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Whole-body Electrical Muscle Stimulation (WB-EMS) ExerciseExperimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NextGen Precision Health Building, Clinical and Translational Science UnitColumbia, MO
University of Kansas Clinical Research CenterFairway, KS
NextGen Precision Health Building, Clinical Translational Science UnitColumbia, MO
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Who Is Running the Clinical Trial?
University of Missouri-ColumbiaLead Sponsor
University of Kansas Medical CenterCollaborator
References
Effects of whole-body ELECTROMYOSTIMULATION on health and performance: a systematic review. [2023]Whole-body electrical myostimulation (WB-EMS) is a relatively recent training methodology that has been extraordinarily used in recent years. However, there is a lack of consensus on the effectiveness of WB-EMS in the situations in which its use has been largely popularized. The objective of this systematic review was to determine the effects produced by WB-EMS.
Bibliometric Analysis of Studies on Whole Body Electromyostimulation. [2022]Whole Body Electromyostimulation [WB-EMS] is a training methodology that applies electrostimulation in the main muscle groups of the human body superimposed with active training exercises. This study aims to carry out a bibliometric analysis on WB-EMS to provide an overview of the state of research and provide new insights for research in the field.
Effects of whole-body electromyostimulation on health indicators of older people: Systematic review and meta-analysis of randomized trials. [2022]to provide evidence for the effects of whole-body electromyostimulation (WB-EMS) on health-related outcomes compared to the effects of minimal or non-intervention for older people in the short/medium/long term.
Effects of Two Modalities of Whole-body Electrostimulation Programs and Resistance Circuit Training on Strength and Power. [2019]The main purpose of this study was to compare the effects on strength and muscle power of a training program based on two different modalities of whole-body electrostimulation (WB-EMS) with respect to a resistance-training program aimed at improving dynamic strength. Twenty-two subjects participated in this study: Thirteen male (age 25.2±2.8 years; height 1.78±0.1 m; body mass 72.8±6.4 kg; body fat 11.6±2.3%) and nine female (age 28.2±3.5 years; height 1.63±0.05 m; body mass 56.8±7.6 kg; body fat 19.1±4.7%). Participants were randomly assigned to three groups that underwent three different 6-week training programs: two modalities of WB-EMS, based on different electrical parameters (experimental), and circuit training with overloads (control). Force-velocity curves were calculated for each participant before and after treatment. All groups improved their level of strength and muscle power (paired sample t-Test, p1) with a similar magnitude. No significant differences were observed between groups (two-way 2×3 Anova, p>0.05) at the end of the experimentation. This study suggests that WB-EMS might be considered as a valid and faster alternative - or an important complementary procedure - to a traditional overload-based resistance-training program for the development of the DS.
Whole-Body Electromyostimulation to Fight Osteopenia in Elderly Females: The Randomized Controlled Training and Electrostimulation Trial (TEST-III). [2022]Whole-body electromyostimulation (WB-EMS) has been shown to be effective in increasing muscle strength and mass in elderly women. Because of the interaction of muscles and bones, these adaptions might be related to changes in bone parameters. 76 community-living osteopenic women 70 years and older were randomly assigned to either a WB-EMS group (n = 38) or a control group (CG: n = 38). The WB-EMS group performed 3 sessions every 14 days for one year while the CG performed gymnastics containing identical exercises without EMS. Primary study endpoints were bone mineral density (BMD) at lumbar spine (LS) and total hip (thip) as assessed by DXA. After 54 weeks of intervention, borderline nonsignificant intergroup differences were determined for LS-BMD (WB-EMS: 0.6 ± 2.5% versus CG -0.7 ± 2.5%, P = .051) but not for thip-BMD (WB-EMS: -1.1 ± 1.9% versus CG: -0.8 ± 2.3%, P = .771). With respect to secondary endpoints, there was a gain in lean body mass (LBM) of 1.5% (P = .006) and an increase in grip strength of 8.4% (P = .000) in the WB-EMS group compared to CG. WB-EMS effects on bone are less pronounced than previously reported effects on muscle mass. However, for subjects unable or unwilling to perform intense exercise programs, WB-EMS may be an option for maintaining BMD at the LS.
Position statement and updated international guideline for safe and effective whole-body electromyostimulation training-the need for common sense in WB-EMS application. [2023]Whole-Body Electromyostimulation (WB-EMS) is a training technology that enables simultaneous stimulation of all the main muscle groups with a specific impulse intensity for each electrode. The corresponding time-efficiency and joint-friendliness of WB-EMS may be particularly attractive for people unable or unmotivated to conduct (intense) conventional training protocols. However, due to the enormous metabolic and musculoskeletal impact of WB-EMS, particular attention must be paid to the application of this technology. In the past, several scientific and newspaper articles reported severe adverse effects of WB-EMS. To increase the safety of commercial non-medical WB-EMS application, recommendations "for safe and effective whole-body electromyostimulation" were launched in 2016. However, new developments and trends require an update of these recommendations to incorporate more international expertise with demonstrated experience in the application of WB-EMS. The new version of these consensus-based recommendations has been structured into 1) "general aspects of WB-EMS", 2) "preparation for training", recommendations for the 3) "WB-EMS application" itself and 4) "safety aspects during and after training". Key topics particularly addressed are 1) consistent and close supervision of WB-EMS application, 2) mandatory qualification of WB-EMS trainers, 3) anamnesis and corresponding consideration of contraindications prior to WB-EMS, 4) the participant's proper preparation for the session, 5) careful preparation of the WB-EMS novice, 6) appropriate regeneration periods between WB-EMS sessions and 7) continuous interaction between trainer and participant at a close physical distance. In summary, we are convinced that the present guideline will contribute to greater safety and effectiveness in the area of non-medical commercial WB-EMS application.
Side effects of whole-body electro-myo-stimulation. [2020]Whole-body-electro-myo-stimulation (WB-EMS) has been introduced as an alternative to physical training. The aim of the review is to summarize the data about indications and side effects of WB-EMS.A literature search in PubMed disclosed 11 randomized trials, 3 cohort studies, and 7 case reports. From healthy volunteers, enormous creatine kinase (CK) elevations were reported. There is a lack of data about biological consequences of WB-EMS on other organs. In randomized trials, CK levels were not investigated, but several patients discontinued WB-EMS because of "muscular discomfort." Contraindications for WB-EMS are not clearly defined. Nine cases of rhabdomyolysis after WB-EMS were found, preferentially after the first application.Regulatory authorities should increase the safety of WB-EMS. Patients with a history of rhabdomyolysis should not undergo WB-EMS and those experiencing rhabdomyolysis should be neurologically investigated. Since the value of WB-EMS as an alternative to physical exercise is uncertain, we need to proof or disproof its benefit.
Side effects of and contraindications for whole-body electro-myo-stimulation: a viewpoint. [2020]Whole-body electro-myo-stimulation (WB-EMS) has been introduced as an alternative to physical training. Data about side effects and contraindications of WB-EMS are summarised. From healthy subjects, elevation of creatine-kinase (CK) activity with inter-individual variability was reported after WB-EMS. No data about applied current types, stimulation frequency and risk factors were given. In randomised trials investigating WB-EMS, CK activity was not measured. Seven cases of rhabdomyolysis after WB-EMS were found, and it remains open whether WB-EMS was the only risk factor. In healthy subjects, WB-EMS does not seem to affect blood pressure, heart rate and oxygen uptake. The lists of exclusion criteria are, in part, contradictory between different studies, especially regarding malignancy and heart failure. Risk factors for rhabdomyolysis are not mentioned as contraindications for WB-EMS. Scientific research should concentrate on muscle damage as a side effect of WB-EMS considering current types applied, stimulation frequency and risk factors for rhabdomyolysis. Research about WB-EMS should include longitudinal muscle force measurements and MRI. Subjects, intending to perform WB-EMS, should undergo investigations by a physician comprising a screen for risk factors for rhabdomyolysis. The education of operators working in gyms with WB-EMS should be regulated and improved. Regulatory authorities should become aware of the problem. Those working in the field should start an initiative on an international level to increase the safety of WB-EMS.
Physical training effects in myasthenia gravis. [2006]Eleven patients with mild or moderate myasthenia gravis (MG) were subjected to a strength training program of 27 to 30 sessions during ten weeks. Voluntary maximal muscle force and the degree of fatigue during repetitive maximal isometric muscle contractions were measured in three muscle groups. The subjects did not experience any subjective discomfort or any adverse effect on their MG due to the training. A 23% increase of the maximal voluntary muscle force in knee extension in the trained side was found, compared to 4% in the untrained side (p
Repetitive nerve stimulation studies in the Lambert-Eaton myasthenic syndrome. [2008]We compared changes in amplitude and area of surface recorded compound motor action potentials (CMAPs) during 20-Hz repetitive nerve stimulation and after maximum voluntary contraction in patients with the Lambert-Eaton myasthenic syndrome (LEMS), myasthenia gravis (MG), and normal controls. There was greater potentiation of CMAP amplitude after voluntary contraction than during 20-Hz stimulation in 10 of 14 LEMS patients; CMAP area increased more after exercise than during 20-Hz stimulation in all LEMS patients. Although abnormal potentiation of CMAP area and amplitude was seen in equal numbers of LEMS patients, more LEMS patients demonstrated a greater than 100% potentiation of CMAP area than of CMAP amplitude. We conclude that maximum voluntary contraction is preferable to brief 20-Hz RNS to demonstrate potentiation in LEMS because it is at least as sensitive and is less painful. Measurement of CMAP area in LEMS patients is not better than measuring the change in CMAP amplitude in demonstrating abnormal potentiation. Testing of a single hand muscle for potentiation in LEMS does not demonstrate abnormal potentiation in all LEMS patients.
Post-exercise exhaustion in Lambert-Eaton myasthenic syndrome. [2019]To study post-exercise exhaustion by decrement (PEE-D) systematically in 24 repetitive nerve stimulation (RNS) tests in 14 patients with Lambert-Eaton myasthenic syndrome (LEMS).
Single fiber EMG and repetitive stimulation of the same muscle in myasthenia gravis. [2004]We performed RNS and SFEMG studies of the same muscle in 46 patients with myasthenia gravis. Maximum decrement to 3-5-Hz stimulation before and after maximum voluntary exercise, percentage of action potential pairs with increased jitter and blocking, and mean MCD in each study were compared. A significant decrement (> 10% decrease in CMAP area or amplitude between the first and fourth response) was never found without increased jitter and impulse blocking on SFEMG. Increased jitter, blocking, and mean MCD were each correlated with maximum decrement (r > 0.61, P
Implementation of tailored exercise programs for MG patients in a gym setting: a pragmatic feasibility case study. [2023]Although supervised aerobic and resistance training in a hospital setting was proven safe and beneficial for well-controlled myasthenia gravis (MG) patients, implementation of similar programs in the community has not been studied. We conducted a pragmatic open-label study at a large gym in Uppsala, Sweden. Seven patients with generalized MG were recruited to participate in an individualized, tailored exercise program, based on individual baseline status and personal goals, with a personal trainer. All patients completed the entire training period. The individually tailored exercise program was implemented safely and effectively, with all patients improving in aerobic capacity, muscle strength, and balance. Our pragmatic open-label case study suggests that well-controlled patients with generalized MG can extend their physical exercise to personal training in the gym. This is an essential step towards reducing the barriers to implementing exercise procols and increasing the availability of these interventions to MG patients.