SarcopeniaNMESNCT07668258
Clinical Trial to Evaluate the Efficacy of Neuromuscular Electrical Stimulation Therapy in Patients With Sarcopenia
A study testing neuromuscular electrical stimulation in people with Sarcopenia, run by Exosystems.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Sarcopenia
- What is being tested?
- neuromuscular electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 9 Jun 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 1) 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
Show all 21Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Center, Randomized, Double-Blind, Sham-Controlled Clinical Trial to Evaluate the Efficacy of Neuromuscular Electrical Stimulation Therapy for Improving Lower-Limb Strength and Physical Performance in Patients With Sarcopenia
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.
Read the detailed description
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.
- Conditions
- Sarcopenia
- Being tested
- neuromuscular electrical stimulation
- Keywords
- sarcopenia, muscle mass, knee strength, Physical Performance
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuromuscular electrical stimulationDevice
once daily, for at least 20 minutes per session, at least 4 times per week, over the 8-week study period
| Study group | Role | What they receive |
|---|---|---|
| NMES Treatment Group | Active comparator | electrical stimulation with an exercise therapy program Receives: Device: neuromuscular electrical stimulation |
| Control Group | Sham comparator | minimal perceptible level electrical stimulation with an exercise therapy program Receives: Device: neuromuscular electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: from baseline to Week 8.
Change in rectus femoris muscle thickness
Muscle thickness (mm) : assessed using ultrasound in Rectus femoris thickness
Measured: 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
Measured: 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
Measured: from baseline to Week 8
Change in gait speed,
Gait speed (m/s) : Assessed using the 6-meter walk test
Measured: 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
Measured: 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
Measured: 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
Measured: from baseline to Week 8
Secondary outcomes (3)
change in handgrip strength
- Handgrip strength (kg)
- Assessed using a Smedley-type handgrip dynamometer.
- Higher values indicate greater muscle strength.
Measured: 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.
Measured: 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.
Measured: from baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start9 Jun 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Exosystems
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Catholic University of Korea
- Responsible party
- Sponsor
- Investigators
- Sangui Choi, CPO, Principal investigator, Exosystems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668258
- Sponsor's protocol ID
- exo-SC-2025
- Other IDs
- RS-2024-00439193
- Acronym
- NMES
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32033882Jandova 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.
PubMed 32911678Kern 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.
PubMed 25104935
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Double-Blind, Sham-Controlled Clinical Trial to Evaluate the Efficacy of Neuromuscular Electrical Stimulation Therapy for Improving Lower-Limb Strength and Physical Performance in Patients With Sarcopenia
- ClinicalTrials.gov ID
- NCT07668258
- Acronym / sponsor ID
- NMES / exo-SC-2025
- Conditions
- Sarcopenia
- Keywords
- sarcopenia, muscle mass, knee strength, Physical Performance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- ExosystemsIndustry (pharma, biotech, devices)
- Collaborators
- The Catholic University of Korea
- Study start
- 9 Jun 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMES Treatment Group | Active comparator | Device: neuromuscular electrical stimulationelectrical stimulation with an exercise therapy program |
| Control Group | Sham comparator | Device: neuromuscular electrical stimulationminimal perceptible level electrical stimulation with an exercise therapy program |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (21 listed)
- 1) 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neuromuscular electrical stimulationonce daily, for at least 20 minutes per session, at least 4 times per week, over the 8-week study period | Device | Control Group, NMES Treatment Group |
Primary outcome
Change in muscle mass
Time frame: from baseline to Week 8.
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).
Change in rectus femoris muscle thickness
Time frame: from baseline to Week 8
Muscle thickness (mm) : assessed using ultrasound in Rectus femoris thickness
Change in isometric knee extensor and flexor strengths
Time frame: from baseline to Week 8
Isometric knee extensor and flexor strengths (N or kgf) : assessed using isometric strength
Change in muscle contraction quality and parameters
Time frame: from baseline to Week 8
* 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
Change in gait speed,
Time frame: from baseline to Week 8
Gait speed (m/s) : Assessed using the 6-meter walk test
Change in Timed Up and Go test
Time frame: from baseline to Week 8
Timed Up and Go test (seconds): Time required to complete the Timed Up and Go test
Change in Short Physical Performance Battery score
Time frame: from baseline to Week 8
Short Physical Performance Battery total score (0-12) : Composite score derived from balance, gait speed, and chair stand performance
Change in five-times sit-to-stand test.
Time frame: from baseline to Week 8
five-times sit-to-stand test (seconds) : Time required to complete five consecutive sit-to-stand movements
3 secondary outcomes
change in handgrip strength
Time frame: from baseline to Week 8
change in Short International Physical Activity Questionnaire scores
Time frame: from baseline to Week 8
change in quality of life related to sarcopenia
Time frame: from baseline to Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Background: PubMed 32033882Chen 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.
- Background: PubMed 32911678Jandova 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.
- Background: PubMed 25104935Kern 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sangui Choi, CPO principal investigator
Exosystems
Questions about this trial
What is this clinical trial studying?
A study testing neuromuscular electrical stimulation in people with Sarcopenia, run by Exosystems.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sangui Choi, CPO (+82-10-3028-7759, tkddml30@exosystems.io), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle mass (time frame: from baseline to Week 8.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07668258, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.