RecruitingNot ApplicableNCT07188350

Neuromuscular Electrical Stimulation in a Patient on Invasive Mechanical Ventilation (MOVCARE)

Neuromuscular Electrical Stimulation of Lower Limbs in Patients Undergoing Invasive Mechanical Ventilation: Randomized Clinical Trial

Sponsor

Hospital Moinhos de Vento

Enrollment

150 participants

Start Date

Sep 4, 2025

Study Type

INTERVENTIONAL

Conditions

Mechanical Ventilation Critical Illness Neuromuscular Electrical Stimulation (NMES)Intensive Care Unit Patients Muscle Weakness Condition

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria1

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.

Exclusion Criteria12

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;
Inability to speak Portuguese or pre-existing cognitive impairment prior to ICU admission;
Any condition that prevents neuromuscular electrical stimulation (NMES) treatment or assessment of the primary outcome in both legs (e.g., skin lesions, fractures, or amputation);
inability to transfer from bed to chair with or without assistance prior to hospital admission;
Cardiac arrest as the cause of ICU admission or cardiac arrest before screening;
Deep vein thrombosis (DVT) or pulmonary embolism (PE) treated for less than 48 hours;
Pregnant patients;
Known or suspected malignancy in the legs;
Any care limitation including a do-not-resuscitate order.

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Interventions

OTHERConventional Physical Therapy

Individualized 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.

DEVICENeuromuscular Electrical Stimulation (NMES)

NMES 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.