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

ConditionSarcopenia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorExosystems

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: NMES Treatment GroupActive comparator 1 intervention
Group B: Control GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
from baseline to Week 8.
2

Change in rectus femoris muscle thickness

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

Time frame
from baseline to Week 8
3

Change in isometric knee extensor and flexor strengths

Isometric knee extensor and flexor strengths (N or kgf) : assessed using isometric strength

Time frame
from baseline to Week 8
4

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

Time frame
from baseline to Week 8

Secondary outcomes

1

change in handgrip strength

1\. Handgrip strength (kg) * Assessed using a Smedley-type handgrip dynamometer. * Higher values indicate greater muscle strength.

Time frame
from baseline to Week 8
2

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.

Time frame
from baseline to Week 8
3

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.

Time frame
from baseline to Week 8

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Exosystems

Lead sponsor

The Catholic University of Korea

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: