Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07188350

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

Led by Hospital Moinhos de Vento · Updated on 2026-03-25

150

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

Sponsors

H

Hospital Moinhos de Vento

Lead Sponsor

F

Federal University of Health Science of Porto Alegre

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of neuromuscular electrical stimulation (NMES) combined with conventional physical therapy in critically ill patients undergoing invasive mechanical ventilation in the intensive care unit (ICU). This randomized clinical trial aims to compare muscle function and recovery between patients receiving only physical therapy and those receiving physical therapy plus NMES. The study focuses on whether NMES can improve muscle strength and clinical outcomes in these patients. Participants will be randomly assigned to either a control group receiving individualized conventional physical therapy, including mobility and respiratory exercises, or an intervention group receiving the same physical therapy plus NMES applied to both lower limbs. NMES will be delivered once daily for up to 14 days or until hospital discharge, using electrodes placed on specific leg muscles and progressive stimulation parameters to induce effective muscle contractions. Safety criteria are in place to postpone NMES sessions if clinical instability is detected. During the study, participants will undergo regular assessments of muscle strength using the Medical Research Council (MRC) sum score at ICU discharge and other time points, along with ultrasound measurements of muscle thickness and pennation angle. Additional evaluations include handgrip strength, knee extension strength, functional capacity by the Six-Minute Walk Test, and monitoring of ventilation duration and hospital stay. The study will continue through hospitalization with follow-up assessments up to six months after discharge to monitor recovery and outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older
  • Under invasive mechanical ventilation
  • Expected to require invasive mechanical ventilation for more than 48 hours
Not Eligible

You will not qualify if you...

  • Body mass index (BMI) of 35 kg/m² or higher
  • ICU stay longer than 7 ICU-free days or more than 3 continuous days of invasive mechanical ventilation before enrollment
  • Known intracranial process such as stroke or intracranial hypertension
  • Neuromuscular diseases like Guillain-Barré syndrome or myasthenia gravis at ICU admission
  • Inability to speak Portuguese or pre-existing cognitive impairment before ICU admission
  • Conditions preventing NMES treatment or primary outcome assessment in both legs (e.g., skin lesions, fractures, amputation)
  • Inability to transfer from bed to chair with or without assistance before hospital admission
  • Cardiac arrest as cause of ICU admission or before screening
  • Deep vein thrombosis or pulmonary embolism treated for less than 48 hours
  • Pregnancy
  • Known or suspected leg malignancy
  • Any care limitation including do-not-resuscitate order

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Up to 14 days or until hospital discharge

Participants receive conventional physical therapy daily, including mobility and respiratory exercises. Those in the intervention group also receive neuromuscular electrical stimulation (NMES) to both lower limbs once daily for up to 14 days or until hospital discharge, whichever comes first.

Daily sessions throughout hospitalization

Follow-up

Duration - Up to 6 months after hospital discharge

Participants are assessed for muscle strength, muscle thickness, functional capacity, and other clinical outcomes at ICU discharge, hospital discharge, and up to 6 months after hospital discharge.

Assessments at ICU discharge, hospital discharge, and 6 months post-discharge

Trial Site Locations

Total: 1 location

1

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil, 90035-902

Actively Recruiting

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Research Team

L

Larissa Carolina Brandão da Cunha, MSc

C

Cassiano Teixeira, Doctor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Routine monitoring of isometric knee extension strength in patients with muscle impairments using a new portable device: cross-validation against a standard isokinetic dynamometer.

Jean-Yves Hogrel, Olivier Benveniste, Damien Bachasson

https://pubmed.ncbi.nlm.nih.gov/31935703

Neuromuscular electrical stimulation acutely mobilizes endothelial progenitor cells in critically ill patients with sepsis.

Christos Stefanou, Eleftherios Karatzanos, Georgios Mitsiou...

https://pubmed.ncbi.nlm.nih.gov/26969168

Safety and feasibility of a neuromuscular electrical stimulation chronaxie-based protocol in critical ill patients: A prospective observational study.

Paulo Eugênio Silva, Nicolas Babault, João Batista Mazullo...

https://pubmed.ncbi.nlm.nih.gov/27732921

Safety of neuromuscular electrical stimulation among critically ill patients: systematic review.

Amanda Sachetti, Marta Fiorvanti Carpes, Alexandre Simões Dias...

https://pubmed.ncbi.nlm.nih.gov/29995088

Muscle weakness in septic patients requiring mechanical ventilation: protective effect of transcutaneous neuromuscular electrical stimulation.

Pablo O Rodriguez, Mariano Setten, Luis P Maskin...

https://pubmed.ncbi.nlm.nih.gov/21715139