Clinical Trial to Evaluate the Efficacy of Neuromuscular Electrical Stimulation Therapy in Patients With Sarcopenia

Starting soon · Not applicable

Conditions studied: Sarcopenia

In brief

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.

Key facts

Study ID

NCT07668258

Run by

Exosystems

People needed

40

Starts

2026-06-09

Expected to finish

2027-02-01

Last updated by the study team

2026-06-25

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with sarcopenia according to the Asian Working Group for Sarcopenia (2019) criteria
• Able to perform the exercise program provided by the investigators, with sufficient physical and cognitive function
• Able to understand the study explanation and provide voluntary informed consent
• Able to operate a mobile phone independently or with assistance from a caregiver

You may not qualify if…

• History of Knee Surgery
• Any prior surgical procedure on either knee (right or left) 2) Recent Knee Injection or Procedure
• Receipt of any injection or interventional procedure in either knee within the past 3 months 3) Ongoing Treatment for Knee Pain
• Currently receiving medication or physical therapy for knee pain 4) Implanted Electrical Devices
• Presence of an implanted electrical device (e.g., pacemaker, electrical stimulator) 5) Seizure Disorder
• Current or past history of seizures requiring medication 6) Severe Peripheral Arterial Disease
• Significant arterial circulatory disorder in the lower extremities 7) Hernia
• Presence of abdominal or inguinal hernia 8) Difficulty Operating Devices
• Difficulty operating medical devices or mobile phones 9) Metal Allergy
• Known metal allergy that interferes with device application 10) Skin Lesions on Thigh
• Skin conditions on the thigh (e.g., burns, scars) that interfere with electrical stimulation 11) Suspected Infection on Thigh
• Signs suggestive of infection on the thigh (e.g., erythema, warmth) 12) Impaired Sensation at Patch Site
• Reduced sensation at the patch site preventing adequate self-reporting 13) End-stage Organ Failure
• Diagnosis of end-stage heart failure or end-stage renal disease requiring dialysis 14) Abnormal Laboratory Findings
• Any of the following (based on the most recent test within 6 months; if unavailable, a screening CBC will be performed):
• Platelet count < 50,000/μL
• Hemoglobin < 8.0 g/dL
• Absolute neutrophil count < 1,000/μL 15) Impaired Ambulation
• Difficulty walking due to visual impairment, fracture, severe muscle paralysis, dizziness, or other causes 16) Inability to Participate in Rehabilitation Exercise
• Judged by the investigator as unable to participate in rehabilitation exercise For example, diagnosis of Cachexia, defined as: Unintentional weight loss ≥ 5% within the past 6 months, or BMI < 20 kg/m² with ≥ 2% weight loss 17) Withdrawal or Lack of Consent 18) Other Reasons
• Any other condition deemed by the investigator to make the participant unsuitable for participation in this clinical trial

Full record on ClinicalTrials.gov

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