An interventional study of neuromuscular electrical stimulation in Sarcopenia, sponsored by Exosystems. Not yet recruiting. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Exosystems · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to exploratorily evaluate the safety and efficacy of a home-based lower extremity muscle strengthening and physical performance enhancement program using Neuromuscular Electrical Stimulation (NMES) devices.
Participants will apply NMES stimulation to both thighs for 8 weeks, at a frequency of at least 4 times per week.
Neuromuscular electrical stimulation (NMES) is a non-invasive, non-surgical, and non-pharmacological intervention that delivers electrical stimulation to superficial skeletal muscles to activate motor nerves, thereby inducing muscle contractions without voluntary effort. In patients with sarcopenia, aging and reduced physical activity lead to progressive declines in muscle mass and strength. This deterioration is closely associated with increased risk of falls, greater physical dependency, and reduced quality of life. In particular, lower extremity muscles-especially the quadriceps-are well-known predictors of gait speed, and maintaining muscle mass and strength in these muscles is critical for improving clinical outcomes.
To date, most studies on NMES have been conducted in older adults, and clinical research specifically targeting patients diagnosed with sarcopenia remains limited. Therefore, this study aims to exploratorily evaluate the safety and efficacy of a home-based program using an NMES device to improve lower extremity muscle strength and physical performance in patients with sarcopenia.
1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 775 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →Exosystems is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1) History of Knee Surgery
Any of the following (based on the most recent test within 6 months; if unavailable, a screening CBC will be performed):
electrical stimulation with an exercise therapy program
Device: neuromuscular electrical stimulation
minimal perceptible level electrical stimulation with an exercise therapy program
Device: neuromuscular electrical stimulation
once daily, for at least 20 minutes per session, at least 4 times per week, over the 8-week study period
Change in muscle mass
Appendicular Skeletal Muscle Mass Index (kg/m²): * Assessed using bioelectrical impedance analysis (BIA). * Calculated as appendicular skeletal muscle mass divided by height squared (kg/m²).
Time frame: from baseline to Week 8.
Change in rectus femoris muscle thickness
Muscle thickness (mm) : assessed using ultrasound in Rectus femoris thickness
Time frame: from baseline to Week 8
Change in isometric knee extensor and flexor strengths
Isometric knee extensor and flexor strengths (N or kgf) : assessed using isometric strength
Time frame: from baseline to Week 8
Change in muscle contraction quality and parameters
* Muscle contraction quality and parameters: Muscle Function Index using NMES * Reported as a numerical score reflecting muscle quality and neuromuscular function. * Higher scores indicate better muscle quality and function
Time frame: from baseline to Week 8
Change in gait speed,
Gait speed (m/s) : Assessed using the 6-meter walk test
Time frame: from baseline to Week 8
Change in Timed Up and Go test
Timed Up and Go test (seconds): Time required to complete the Timed Up and Go test
Time frame: from baseline to Week 8
Change in Short Physical Performance Battery score
Short Physical Performance Battery total score (0-12) : Composite score derived from balance, gait speed, and chair stand performance
Time frame: from baseline to Week 8
Change in five-times sit-to-stand test.
five-times sit-to-stand test (seconds) : Time required to complete five consecutive sit-to-stand movements
Time frame: from baseline to Week 8
change in handgrip strength
1\. Handgrip strength (kg) * Assessed using a Smedley-type handgrip dynamometer. * Higher values indicate greater muscle strength.
Time frame: from baseline to Week 8
change in Short International Physical Activity Questionnaire scores
Short International Physical Activity Questionnaire total scores (MET-min/week) * Assessed using a 7-item self-administered questionnaire. * Higher scores indicate greater physical activity levels.
Time frame: from baseline to Week 8
change in quality of life related to sarcopenia
Sarcopenia-Related Quality of Life total score (0-100) * Assessed using the SarQoL questionnaire. * Higher scores indicate better quality of life.
Time frame: from baseline to Week 8
No study locations are listed for this record.
Plan to share: Undecided
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Exosystems