Neuromuscular electrical stimulation in mechanically ventilated patients: a randomized, sham-controlled pilot trial with blinded outcome assessment.
Michelle E Kho, Alexander D Truong, Jennifer M Zanni...
https://pubmed.ncbi.nlm.nih.gov/25307979/Actively Recruiting
Led by Hospital Moinhos de Vento · Updated on 2026-03-25
150
Participants Needed
1
Research Sites
25 weeks
Total Duration
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
Neuromuscular Electrical Stimulation in a Patient on Invasive Mechanical Ventilation (MOVCARE)
L
Larissa Carolina Brandão da Cunha, MSc
C
Cassiano Teixeira, Doctor
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Hospital Moinhos de Vento
Lead Sponsor
Federal University of Health Science of Porto Alegre
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/32897665/Hospital Moinhos de Vento
Lead Sponsor
Federal University of Health Science of Porto Alegre
Collaborating Sponsor