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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство neuromuscular electrical stimulation
  once daily, for at least 20 minutes per session, at least 4 times per week, over the 8-week study period

Первичные конечные точки

• Change in muscle mass [Срок оценки: from baseline to Week 8.]
• Change in rectus femoris muscle thickness [Срок оценки: from baseline to Week 8]
• Change in isometric knee extensor and flexor strengths [Срок оценки: from baseline to Week 8]
• Change in muscle contraction quality and parameters [Срок оценки: from baseline to Week 8]
• Change in gait speed, [Срок оценки: from baseline to Week 8]
• Change in Timed Up and Go test [Срок оценки: from baseline to Week 8]
• Change in Short Physical Performance Battery score [Срок оценки: from baseline to Week 8]
• Change in five-times sit-to-stand test. [Срок оценки: from baseline to Week 8]

Вторичные конечные точки (3)

• change in handgrip strength [Срок оценки: from baseline to Week 8]
• change in Short International Physical Activity Questionnaire scores [Срок оценки: from baseline to Week 8]
• change in quality of life related to sarcopenia [Срок оценки: from baseline to Week 8]

Критерии участия

Критерии включения

• 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

Критерии исключения

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):

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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 PMID 32033882
• 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
• 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

Идентификаторы

NCT: NCT07668258 · exo-SC-2025 · RS-2024-00439193

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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