Neuromuscular electrical stimulation for patients on invasive mechanical ventilation (MOVCARE)

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

We will test whether adding neuromuscular electrical stimulation to usual physical therapy helps adults on invasive mechanical ventilation regain leg muscle strength faster.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hospital Moinhos de Vento (Academic / other)
• Locations: 1 site (Porto Alegre, Rio Grande do Sul)
• Trial ID: NCT07188350 on ClinicalTrials.gov

What this trial studies

This randomized study will compare conventional physical therapy alone versus the same therapy combined with neuromuscular electrical stimulation (NMES) in critically ill adults receiving invasive mechanical ventilation. Participants are randomly assigned to a control group receiving individualized physiotherapy or an intervention group receiving the same physiotherapy plus NMES applied to multiple lower-limb muscles once or twice daily for up to 14 days or until discharge. NMES uses rectangular electrodes on the quadriceps, tibialis anterior, hamstrings, and gastrocnemius with session timing and safety rules that postpone stimulation during clinical instability. The trial is conducted at Hospital Moinhos de Vento and includes predefined inclusion and exclusion criteria to ensure safety and assess muscle function outcomes.

Who should consider this trial

Good fit: Adults (18+) who are receiving invasive mechanical ventilation and are expected to need ventilation for more than 48 hours, without exclusions that prevent NMES or outcome assessment, are ideal candidates.

Not a fit: Patients with high BMI (≥35), preexisting neuromuscular disease, intracranial processes, skin lesions or amputations preventing NMES, long prior ICU ventilation, or other listed exclusions are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, adding NMES could reduce ICU-acquired muscle weakness and help patients recover mobility and independence faster.

How similar studies have performed: Previous clinical trials of NMES in critically ill patients have shown mixed results, with some small studies reporting improved muscle mass or strength but inconsistent effects on functional recovery.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Porto Alegre, Rio Grande do Sul

• Hospital Moinhos de Vento — Porto Alegre, Rio Grande do Sul, Brazil (Recruiting)

Study contacts

• Principal investigator: Cassiano TEIXEIRA, PhD — Hospital Moinhos de Vento
• Study coordinator: Larissa Carolina Brandão da Cunha, MSc

Conditions Mechanical Ventilation; Critical Illness; Intensive Care Unit Patients; Muscle Weakness Condition; Neuromuscular Electrical Stimulation; Physiotherapy; Muscle Strength; Randomized Controlled Trial