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

NCT07188350 | Recruiting

• 1 other identifier: MOVCARE2025-LB
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Neuromuscular Electrical Stimulation; Physiotherapy; Mechanical Ventilation; Muscle Strength; Randomized Controlled Trial; Critical Illness

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 24 hours after ICU discharge

Secondary Outcomes (24)

• Rectus femoris muscle thickness measured by ultrasound at initiation of invasive mechanical ventilation

  within 24 hours after enrollment

• Rectus femoris pennation angle measured by ultrasound at initiation of invasive mechanical ventilation

  within 24 hours after enrollment

• Rectus femoris pennation angle measured by ultrasound at sedation awakening

  Within 24 hours after awakening from sedation in the ICU

• Rectus femoris muscle thickness measured by ultrasound at sedation awakening

  Within 24 hours after awakening from sedation in the ICU

• Rectus femoris pennation angle measured by ultrasound at ICU discharge

  Within 24 hours after ICU discharge

Study Arms (2)

Conventional Physical Therapy

ACTIVE COMPARATOR

Participants in this group will receive individualized conventional physical therapy, including progressive mobility exercises, in-bed activities (e.g., rolling, sitting at the edge of the bed), standing, transferring to a chair, walking, and respiratory therapy as clinically indicated. Treatments will be adjusted daily based on each patient's physiological status.

Other: Conventional Physical Therapy

Conventional Physical Therapy + Neuromuscular Electrical Stimulation

EXPERIMENTAL

Participants in this group will receive the same conventional physical therapy as the control group, plus neuromuscular electrical stimulation (NMES) applied to both lower limbs once or twice daily for 14 consecutive days. NMES will be administered to the vastus lateralis, vastus medialis, tibialis anterior, hamstrings, and gastrocnemius muscles using specific parameters to produce effective muscle contractions, following a progressive stimulation protocol throughout the intervention period.

Other: Conventional Physical Therapy; Device: Neuromuscular Electrical Stimulation (NMES)

Interventions

Conventional Physical Therapy OTHER

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.

Conventional Physical Therapy; Conventional Physical Therapy + Neuromuscular Electrical Stimulation

Neuromuscular Electrical Stimulation (NMES) DEVICE

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.

Conventional Physical Therapy + Neuromuscular Electrical Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Moinhos de Vento: lead
• Federal University of Health Science of Porto Alegre: collaborator

Study Sites (1)

Hospital Moinhos de Vento

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

RECRUITING

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MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cassiano TEIXEIRA, PhD

  Hospital Moinhos de Vento

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Larissa Carolina Brandão da Cunha, MSc

CONTACT

+5551996285425; larissabran@yahoo.com.br

Cassiano Teixeira, Doctor

CONTACT

+5551999687062; cassiano.rush@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The outcomes assessor will be blinded to participant group assignment to minimize bias in outcome evaluation. Participants and care providers will be aware of group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doutor

Model Details: Participants will be randomly assigned to one of two groups in a parallel design: the control group receiving conventional physical therapy, and the intervention group receiving conventional physical therapy plus neuromuscular electrical stimulation. Both groups will be treated simultaneously during the study period.

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: September 23, 2025
• Study Start: September 4, 2025
• Primary Completion (Estimated): September 5, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Starting 6 months after study completion and available for 5 years
• Access Criteria: Qualified researchers affiliated with academic or research institutions will be eligible to access the de-identified individual participant data and supporting documents, including the study protocol and statistical analysis plan. Access will be granted after submission and approval of a research proposal by the study's data sharing committee. Researchers must agree to a data use agreement ensuring confidentiality and appropriate use of the data. Data and documents will be shared via secure data transfer methods.

Locations

BR (1)