Status:
RECRUITING
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Myasthenia Gravis
Lead Sponsor:
University of Missouri-Columbia
Collaborating Sponsors:
University of Kansas Medical Center
Conditions:
Generalized Myasthenia Gravis
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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) transmissi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06064695
Start Date
July 12 2023
End Date
August 1 2025
Last Update
April 10 2025
Active Locations (2)
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1
University of Kansas Clinical Research Center
Fairway, Kansas, United States, 66205
2
NextGen Precision Health Building, Clinical and Translational Science Unit
Columbia, Missouri, United States, 65211