This clinical study aims to compare the effects of conventional physical therapy alone versus conventional physical therapy combined with neuromuscular electrical stimulation (NMES) in patients admitted to the ICU and undergoing invasive mechanical ventilation. Participants will be randomly assigned to receive either conventional physical therapy or the same therapy plus NMES applied to the lower limbs. The protocol includes muscle-specific stimulation parameters and safety criteria to postpone sessions in cases of clinical instability. The primary goal is to assess whether NMES improves muscle function and recovery in critically ill patients.
Patients will be eligible if they are 18 years or older, are under invasive mechanical ventilation (IMV), and are expected to require IMV for more than 48 hours.
Body mass index (BMI) greater than or equal to 35 kg/m²;
Length of ICU stay longer than 7 ICU-free days or more than 3 continuous days of invasive mechanical ventilation (IMV) before enrollment;
Known intracranial process (e.g., stroke, intracranial hypertension);
Neuromuscular disease (e.g., Guillain-Barré syndrome, myasthenia gravis) at ICU admission;
Parallel
Conventional Physical Therapy
Other interventionIndividualized physical therapy including progressive mobility (e.g., bed exercises, sitting on the edge of the bed, standing, transfers, and ambulation) and respiratory therapy tailored to the patient's clinical condition. Delivered daily by trained professionals.
Neuromuscular Electrical Stimulation (NMES)
DeviceNMES will be applied to both lower limbs once or twice daily for 20 consecutive days. Electrodes will be positioned on the vastus lateralis, vastus medialis, tibialis anterior, hamstrings, and gastrocnemius muscles. The stimulation protocol includes progressive parameters to induce visible and effective muscle contractions.
Muscle strength assessed by the Medical Research Council (MRC) sum score at ICU discharge
Muscle strength will be evaluated by trained physiotherapists using the Medical Research Council (MRC) scale, which grades muscle strength from 0 (no contraction) to 5 (normal strength) in key muscle groups, with a maximum total score of 60 points. Muscle weakness is defined as a score below 48 points. This scale provides a standardized method to evaluate muscular recovery during critical illness and hospitalization.
Rectus femoris muscle thickness measured by ultrasound at initiation of invasive mechanical ventilation
The thickness of the rectus femoris muscle will be measured in millimeters using ultrasound imaging performed by trained professionals, in order to assess muscle morphology.
Rectus femoris pennation angle measured by ultrasound at initiation of invasive mechanical ventilation
The quadriceps muscle (specifically the rectus femoris) will be evaluated using ultrasound imaging by trained professionals. The pennation angle of the rectus femoris will be measured in degrees to assess muscle architecture.
Rectus femoris pennation angle measured by ultrasound at sedation awakening
The quadriceps muscle (specifically the rectus femoris) will be evaluated using ultrasound imaging by trained professionals. The pennation angle (in degrees) will be measured. Assessments will be performed when sedation is reduced or stopped to the point that the patient can respond to at least three motor commands (e.g., blink eyes, look at the examiner, stick out tongue, shake head, or raise eyebrows), in order to assess muscle architecture at sedation awakening. Unit of Measure: degrees (°)
Rectus femoris muscle thickness measured by ultrasound at sedation awakening
The quadriceps muscle (specifically the rectus femoris) will be evaluated using ultrasound imaging by trained professionals. Muscle thickness (in millimeters) will be measured. Assessments will be performed when sedation is reduced or stopped to the point that the patient can respond to at least three motor commands (e.g., blink eyes, look at the examiner, stick out tongue, shake head, or raise eyebrows), in order to assess muscle morphology at sedation awakening. Unit of Measure: millimeters (mm)
Click on the lead sponsor to view all of their trials.
Hospital Moinhos de Vento
Lead sponsor
Federal University of Health Science of Porto Alegre
Collaborator
