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

NCT07668258 | Not Yet Recruiting DMC

• 2 other identifiers: exo-SC-2025RS-2024-00439193
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sarcopenia

Keywords

sarcopenia; muscle mass; knee strength; Physical Performance

Outcome Measures

Primary Outcomes (8)

• 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).

  from baseline to Week 8.

• Change in rectus femoris muscle thickness

  Muscle thickness (mm) : assessed using ultrasound in Rectus femoris thickness

  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

  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

  from baseline to Week 8

• Change in gait speed,

  Gait speed (m/s) : Assessed using the 6-meter walk test

  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

  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

  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

  from baseline to Week 8

Secondary Outcomes (3)

• change in handgrip strength

  from baseline to Week 8

• change in Short International Physical Activity Questionnaire scores

  from baseline to Week 8

• change in quality of life related to sarcopenia

  from baseline to Week 8

Study Arms (2)

NMES Treatment Group

ACTIVE COMPARATOR

electrical stimulation with an exercise therapy program

Device: neuromuscular electrical stimulation

Control Group

SHAM COMPARATOR

minimal perceptible level electrical stimulation with an exercise therapy program

Device: neuromuscular electrical stimulation

Interventions

neuromuscular electrical stimulation DEVICE

once daily, for at least 20 minutes per session, at least 4 times per week, over the 8-week study period

Control Group; NMES Treatment Group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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):

Sponsors & Collaborators

• Exosystems: lead
• The Catholic University of Korea: collaborator

Related Publications (3)

• Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.

  PMID: 32033882 BACKGROUND

• Jandova T, Narici MV, Steffl M, Bondi D, D'Amico M, Pavlu D, Verratti V, Fulle S, Pietrangelo T. Muscle Hypertrophy and Architectural Changes in Response to Eight-Week Neuromuscular Electrical Stimulation Training in Healthy Older People. Life (Basel). 2020 Sep 8;10(9):184. doi: 10.3390/life10090184.

  PMID: 32911678 BACKGROUND

• Kern H, Barberi L, Lofler S, Sbardella S, Burggraf S, Fruhmann H, Carraro U, Mosole S, Sarabon N, Vogelauer M, Mayr W, Krenn M, Cvecka J, Romanello V, Pietrangelo L, Protasi F, Sandri M, Zampieri S, Musaro A. Electrical stimulation counteracts muscle decline in seniors. Front Aging Neurosci. 2014 Jul 24;6:189. doi: 10.3389/fnagi.2014.00189. eCollection 2014.

  PMID: 25104935 BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Sangui Choi, CPO

  Exosystems

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sangui Choi, CPO

CONTACT

+82-10-3028-7759; tkddml30@exosystems.io

JongIn LEE, M.D.

CONTACT

82-2-2258-6283; ljikyh@catholic.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 25, 2026
• Study Start: June 9, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-06