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| ID | Type | Description | Link |
|---|---|---|---|
| RS-2024-00439193 | Other Grant/Funding Number | the Ministry of Health & Welfare, Republic of Korea |
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| Name | Class |
|---|---|
| The Catholic University of Korea | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NMES Treatment Group | Active Comparator | electrical stimulation with an exercise therapy program |
|
| Control Group | Sham Comparator | minimal perceptible level electrical stimulation with an exercise therapy program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in muscle mass | Appendicular Skeletal Muscle Mass Index (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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change in handgrip strength | 1. Handgrip strength (kg)
| from baseline to Week 8 |
| change in Short International Physical Activity Questionnaire scores |
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Inclusion Criteria:
Exclusion Criteria:
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
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):
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sangui Choi, CPO | Contact | +82-10-3028-7759 | tkddml30@exosystems.io | |
| JongIn LEE, M.D. | Contact | 82-2-2258-6283 | ljikyh@catholic.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Sangui Choi, CPO | Exosystems | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32033882 | Background | 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. | |
| 32911678 |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| 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 |
Short International Physical Activity Questionnaire total scores (MET-min/week)
|
| from baseline to Week 8 |
| change in quality of life related to sarcopenia | Sarcopenia-Related Quality of Life total score (0-100)
| from baseline to Week 8 |
| 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. |
| 25104935 | 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. |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |