Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Myasthenia Gravis

Part of paid clinical trials in Fairway, Kansas.

Sponsor
University of Missouri-Columbia
Study ID
NCT06064695
Status
Recruiting
Apply to this trial

Conditions

  • Generalized Myasthenia Gravis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Whole-body Electrical Muscle Stimulation Exercise — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jul 12, 2023
Status verified
Apr 2025
Primary completion
Apr 30, 2025
Completion
Aug 31, 2025

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Whole-body Electrical Muscle Stimulation (WB-EMS) Exercise
    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.

Primary Outcome Measure

Mean change from baseline in single fiber electromyography (SFEMG) jitter [ Time Frame: Measured within 3 days of starting the intervention and within 3 days of completing the intervention ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Kansas Clinical Research CenterFairwayKansas66205
Fairway Clinical and Translational Research Unit
913-588-1227
Mamatha Pasnoor, MD (PRINCIPAL_INVESTIGATOR)
NextGen Precision Health Building, Clinical and Translational Science UnitColumbiaMissouri65211
Manny Morales
[email protected]
573-882-8571
Stacee Baker
[email protected]
Kristina M Kelly, DPT (PRINCIPAL_INVESTIGATOR)
W David Arnold, MD (SUB_INVESTIGATOR)

Find similar trials in Fairway, KS

By research site
University of Kansas Clinical Research Center· Fairway, KSNextGen Precision Health Building, Clinical and Translational Science Unit· Columbia, MO

Related Studies