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NCT07478172

Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease

StatusActive, Not Recruiting
PhaseNot applicable
Primary completion (estimated)
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 19 words
    • Enrollment closed, study ongoing
    • Secondary endpoints: details revised at 5 of 5 entries
    • Site details revised
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Mean change from baseline in motor unit firing rates using decomposition electromyography (dEMG)
Timeframe: Measured 4-7 days prior to the start of intervention (Week 1) and 4-7 days after 4 weeks of intervention (Week 6 and Week 11).
Mean change from baseline in motor evoked potentials using transcranial magnetic stimulation (TMS)
Timeframe: Measured 4-7 days prior to the start of intervention (Week 1) and 4-7 days after 4 weeks of intervention (Week 6 and Week 11).
Mean change from baseline in compound muscle action potential ampliutde using standard nerve conduction study technique
Timeframe: Measured 4-7 days prior to the start of intervention (Week 1) and 4-7 days after 4 weeks of intervention (Week 6 and Week 11).
Mean change from baseline in timed functional tests
Timeframe: Measured 4-7 days prior to the start of intervention (Week 1) and 4-7 days after 4 weeks of intervention (Week 6 and Week 11).

Secondary (5)

Mean change from baseline in perceived fatigue on a person's life
Mean change from baseline in severity of pain and impact of pain on daily life
Mean change from baseline in the impact of the participant's neuromuscular condition
Mean change from baseline on the broad jump test
Mean change from baseline in the multidirectional lunge test

Arms and interventions

Adults with Neuromuscular DiseaseExperimental

Participants will complete 1-2 WB-EMS Exercise visits per week for 4-8 weeks. Participants in this study will only perform Level 1 exercise programs in the "Strength" Training Mode. These programs are 20-minute videos led by exercise professionals. 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"). While the participant is following along with the video, they will be monitored and stimulation levels adjusted based on participant responses. Monitoring includes maintenance of moderate intensity level rate of perceived exertion and provision of verbal or tactile cues as needed to prompt biomechanically safe performance of each exercise movement. The exercise program (and thereby the stimulation) can be paused at any time by simply apping anywhere on the iPad screen.

Devices: Whole-body Electrical Muscle Stimulation Exercise

Sites

1 site in 1 country

  • NextGen Precision Health Building, Clinical and Translational Science UnitColumbia, Missouri, United States