Sarcopenia
Conditions
Keywords
sarcopenia, muscle mass, knee strength, Physical Performance
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.
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.
Interventions
DEVICEneuromuscular electrical stimulation
once daily, for at least 20 minutes per session, at least 4 times per week, over the 8-week study period
Sponsors
Exosystems
The Catholic University of Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with sarcopenia according to the Asian Working Group for Sarcopenia (2019) criteria 2. Able to perform the exercise program provided by the investigators, with sufficient physical and cognitive function 3. Able to understand the study explanation and provide voluntary informed consent 4. Able to operate a mobile phone independently or with assistance from a caregiver
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): * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in muscle mass | 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 | from baseline to Week 8 | Muscle thickness (mm) : assessed using ultrasound in Rectus femoris thickness |
| Change in isometric knee extensor and flexor strengths | 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 | 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, | from baseline to Week 8 | Gait speed (m/s) : Assessed using the 6-meter walk test |
| Change in Timed Up and Go test | 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 | 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. | from baseline to Week 8 | five-times sit-to-stand test (seconds) : Time required to complete five consecutive sit-to-stand movements |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in handgrip strength | from baseline to Week 8 | 1\. Handgrip strength (kg) * Assessed using a Smedley-type handgrip dynamometer. * Higher values indicate greater muscle strength. |
| change in Short International Physical Activity Questionnaire scores | from baseline to Week 8 | 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. |
| change in quality of life related to sarcopenia | from baseline to Week 8 | Sarcopenia-Related Quality of Life total score (0-100) * Assessed using the SarQoL questionnaire. * Higher scores indicate better quality of life. |
Contacts
CONTACTSangui Choi, CPO
CONTACTJongIn LEE, M.D.
PRINCIPAL_INVESTIGATORSangui Choi, CPO
Exosystems
Outcome results
None listed