Trial Title:
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Myasthenia Gravis
NCT ID:
NCT06064695
Condition:
Generalized Myasthenia Gravis
Conditions: Official terms:
Myasthenia Gravis
Muscle Weakness
Conditions: Keywords:
Exercise
Electrical Stimulation
Fatigue
Neuromuscular Junction Pathology
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Whole-body Electrical Muscle Stimulation Exercise
Description:
This is a fitness device that delivers whole-body electrical muscle stimulation in
conjunction with exercise programs using an iPad App. The stimulation suit (fitted
shorts/shirt, vest, leg straps, arm straps) will be donned with the assistance of trained
research personnel. Muscle groups stimulated include biceps, triceps, pectorals,
abdominals, periscapular musculature, paraspinal musculature, gluteus musculature,
quadriceps, and hamstrings. The stimulation level of each individual muscle group can be
tailored to participant responses and tolerance (i.e. stimulation of the quadriceps and
biceps can occur at different settings). While the participant is following along with
the video, a qualified health care professional will be monitoring and adjusting the
stimulation levels based on participant responses; rate of perceived exertion will also
be monitored to ensure safe moderate intensity levels are maintained.
Arm group label:
Whole-body Electrical Muscle Stimulation (WB-EMS) Exercise
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 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. 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.
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) 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. The investigators will use single fiber electromyography (SFEMG) to
capture pre- and post-treatment jitter, which measures NMJ transmission variability. The
investigators will use decomposition electromyography and clinical measures to assess
pre- and posttreatment fatigability of motor units and muscles. and associate these with
baseline values for NMJ transmission to determine the relationship between these
variables. At the conclusion of the study, expected outcomes include: (1) preliminary
data regarding the efficacy of WB-EMS Exercise to address fatigability, (2) an indication
of whether this type of exercise may promote NMJ remodeling, and (3) clarification of
mechanistic connections between NMJ transmission and fatigability. These findings will
provide new insights into mechanisms of fatigability and responses to exercise in gMG.
The long-term goal is to define the effects of exercise on gMG pathophysiology and
identify effective and tolerable modes of exercise that can be recommended to manage and
prevent gMG-related fatigue.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Kansas Clinical Research Center
Address:
City:
Fairway
Zip:
66205
Country:
United States
Status:
Recruiting
Contact:
Last name:
Fairway Clinical and Translational Research Unit
Phone:
913-588-1227
Investigator:
Last name:
Mamatha Pasnoor, MD
Email:
Principal Investigator
Facility:
Name:
NextGen Precision Health Building, Clinical and Translational Science Unit
Address:
City:
Columbia
Zip:
65211
Country:
United States
Status:
Recruiting
Contact:
Last name:
Theresa Musket
Phone:
573-882-8571
Email:
muskett@missouri.edu
Contact backup:
Last name:
Stacee Baker
Email:
bakersa@health.missouri.edu
Investigator:
Last name:
Kristina M Kelly, DPT
Email:
Principal Investigator
Investigator:
Last name:
W David Arnold, MD
Email:
Sub-Investigator
Start date:
July 12, 2023
Completion date:
December 2024
Lead sponsor:
Agency:
University of Missouri-Columbia
Agency class:
Other
Collaborator:
Agency:
University of Kansas Medical Center
Agency class:
Other
Source:
University of Missouri-Columbia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06064695
