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

Not Applicable

Recruiting

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

• Registration Number: NCT07188350
• Lead Sponsor: Hospital Moinhos de Vento

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.

Detailed Description

This randomized clinical trial will investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients undergoing invasive mechanical ventilation. Participants will be randomly assigned to two groups: a control group receiving conventional physical therapy alone and an intervention group receiving conventional physical therapy combined with NMES.

The control group will receive individualized conventional physical therapy, adjusted daily based on each patient's physiological status and following protocols supported by current literature. Interventions may include progressive mobility, such as bed exercises, rolling, sitting at the edge of the bed, standing, chair transfers, and ambulation, as well as respiratory physiotherapy techniques including bronchial hygiene, pulmonary re-expansion, and management of mechanical ventilation. Sessions will last approximately 20 minutes and continue throughout hospitalization, except in cases of clinical contraindications or refusal by the patient/family.

The NMES group will receive the same conventional physical therapy described above, plus NMES applied once or twice daily to both lower limbs for up to 20 consecutive days or until hospital discharge, whichever comes first.

Rectangular electrodes (90 × 50 mm) will be placed bilaterally on the vastus lateralis, vastus medialis, tibialis anterior, hamstrings, and gastrocnemius muscles. If hair interferes with electrode adhesion, the area will be shaved.

NMES will be delivered using the ReCARE® device (Visuri, MG, Brazil) with the following parameters:

Frequency: 60 Hz

Pulse duration: 500 µs

Intensity: adjusted to produce visible muscle contractions during the first two days and, from day three onward, contractions sufficient to generate movement against gravity.

Contraction (on) and relaxation (off) times and the number of contractions will be progressively adjusted according to the 20-day protocol:

Days 1-2: On = 9s, Off = 27s, 16 contractions, 2x/day

Days 3-6: On = 9s, Off = 25s, 26 contractions, 2x/day

Days 6-9: On = 9s, Off = 22s, 60 contractions, 1x/day

Days 10-15: On = 9s, Off = 20s, 70 contractions, 1x/day

Days 16-20: On = 12s, Off = 15s, 70 contractions, 1x/day

NMES sessions will be postponed if the participant exhibits any of the following clinical findings within three hours prior to the session:

Acidosis (arterial pH \< 7.25 or venous pH \< 7.20)

Hypotension or hypertension (mean arterial pressure \< 60 mmHg or \> 140 mmHg)

Use of a single vasopressor at \>50% of the ICU maximum dose (e.g., dopamine \>12.5 µg/kg/min, phenylephrine \>2 µg/kg/min, vasopressin ≥0.02 U/min, norepinephrine \>1 µg/kg/min)

Use of two vasopressors at ≥40% of the ICU maximum dose

New diagnosis of pulmonary embolism or deep vein thrombosis without anticoagulation for more than 48 hours

Other signs of physiological instability, including temperature \<34°C or \>41°C, lactate \>3.0 mmol/L, creatine kinase \>400 U/L, platelet count \<20,000/mm³, or suspected muscle inflammation (e.g., rhabdomyolysis, myositis, neuroleptic malignant syndrome, or serotonin syndrome).

This study aims to determine whether NMES, as an early adjunct therapy, can improve recovery and clinical outcomes in critically ill mechanically ventilated patients when combined with conventional physical therapy.

Study Timeline

• Study First Submitted: 2025-07-15
• Status Verified: 2025-09
• Study Start: 2025-09-04
• Study First Submitted QC: 2025-09-20
• Last Update Submitted: 2025-09-20
• Study First Posted: 2025-09-23
• Last Update Posted: 2025-09-23
• Primary Completion: 2026-09-05
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 independently from bed to chair before ICU 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Muscle strength assessed by the Medical Research Council (MRC) sum score at ICU discharge	Within 24 hours after 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.

Secondary Outcome Measures

Name	Time	Method
Rectus femoris muscle thickness measured by ultrasound at initiation of invasive mechanical ventilation	within 24 hours after enrollment	The thickness of the rectus femoris muscle will be measured in millimeters using ultrasound imaging performed by trained professionals, in order to assess muscle morphology.
Rectus femoris pennation angle measured by ultrasound at initiation of invasive mechanical ventilation	within 24 hours after enrollment	The quadriceps muscle (specifically the rectus femoris) will be evaluated using ultrasound imaging by trained professionals. The pennation angle of the rectus femoris will be measured in degrees to assess muscle architecture.
Rectus femoris pennation angle measured by ultrasound at sedation awakening	Within 24 hours after awakening from sedation in the ICU	The quadriceps muscle (specifically the rectus femoris) will be evaluated using ultrasound imaging by trained professionals. The pennation angle (in degrees) will be measured. Assessments will be performed when sedation is reduced or stopped to the point that the patient can respond to at least three motor commands (e.g., blink eyes, look at the examiner, stick out tongue, shake head, or raise eyebrows), in order to assess muscle architecture at sedation awakening.; Unit of Measure: degrees (°)
Rectus femoris muscle thickness measured by ultrasound at sedation awakening	Within 24 hours after awakening from sedation in the ICU	The quadriceps muscle (specifically the rectus femoris) will be evaluated using ultrasound imaging by trained professionals. Muscle thickness (in millimeters) will be measured. Assessments will be performed when sedation is reduced or stopped to the point that the patient can respond to at least three motor commands (e.g., blink eyes, look at the examiner, stick out tongue, shake head, or raise eyebrows), in order to assess muscle morphology at sedation awakening.; Unit of Measure: millimeters (mm)
Rectus femoris pennation angle measured by ultrasound at ICU discharge	Within 24 hours after ICU discharge	The quadriceps muscle (specifically the rectus femoris) will be evaluated using ultrasound imaging by trained professionals. The pennation angle (in degrees) will be measured to assess muscle architecture. Each value will be recorded individually at ICU discharge.; Unit of Measure: degrees (°)
Rectus femoris muscle thickness measured by ultrasound at ICU discharge	Within 24 hours after ICU discharge	The quadriceps muscle (specifically the rectus femoris) will be evaluated using ultrasound imaging by trained professionals. Muscle thickness (in millimeters) will be measured to assess muscle morphology. Each value will be recorded individually at ICU discharge.; Unit of Measure: millimeters (mm)
Rectus femoris pennation angle measured by ultrasound at hospital discharge	From 48 hours to 0 hours before hospital discharge	The quadriceps muscle (specifically the rectus femoris) will be evaluated using ultrasound imaging by trained professionals. The pennation angle (in degrees) will be measured to assess muscle architecture. Assessments will be performed at hospital discharge.; Unit of Measure: degrees (°)
Rectus femoris muscle thickness measured by ultrasound at hospital discharge	From 48 hours to 0 hours before hospital discharge	The quadriceps muscle (specifically the rectus femoris) will be evaluated using ultrasound imaging by trained professionals. Muscle thickness (in millimeters) will be measured to assess muscle morphology. Assessments will be performed at hospital discharge.; Unit of Measure: millimeters (mm)
Muscle strength assessed by the Medical Research Council (MRC) sum score at awakening from sedation	Within 24 hours after awakening from sedation in the ICU	Muscle strength will be evaluated by trained physiotherapists using the Medical Research Council (MRC) sum score, 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. Assessments will be performed when sedation is reduced or stopped so that the patient can respond to at least three motor commands (e.g., blink eyes, look at examiner, stick out tongue, shake head, raise eyebrows) to assess muscle strength at sedation awakening.
Muscle strength assessed by the Medical Research Council (MRC) sum score at hospital discharge	From 48 hours to 0 hours before hospital 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. Assessments will be performed at three time points: awakening from sedation, ICU discharge, and hospital discharge. This scale provides a standardized method to evaluate muscular recovery during critical illness and hospitalization.
Handgrip strength measured at awakening from sedation in the ICU	Within 24 hours after awakening from sedation in the ICU	Handgrip strength will be assessed using a handheld hydraulic dynamometer, which measures the maximum force the participant can apply by squeezing the device with their hand. The participant will remain seated with their feet flat on the floor and the arm positioned in a standardized manner to ensure measurement accuracy. Assessments will be performed when sedation is reduced or stopped so that the patient can respond to at least three motor commands (e.g., blink eyes, look at examiner, stick out tongue, shake head, raise eyebrows) to assess muscle.
Handgrip strength measured at ICU discharge	Within 24 hours after ICU discharge	Handgrip strength will be assessed using a handheld hydraulic dynamometer, which measures the maximum force the participant can apply by squeezing the device with their hand. The participant will remain seated with their feet flat on the floor and the arm positioned in a standardized manner to ensure measurement accuracy.
Handgrip strength measured at hospital discharge	From 48 hours to 0 hours before hospital discharge	Handgrip strength will be assessed using a handheld hydraulic dynamometer, which measures the maximum force the participant can apply by squeezing the device with their hand. The participant will remain seated with their feet flat on the floor and the arm positioned in a standardized manner to ensure measurement accuracy.
Isometric Knee Extension Strength Assessed at Awakening From Sedation in the ICU	Within 24 hours after awakening from sedation in the ICU	Isometric knee extension strength will be assessed using a portable dynamometer. Participants will be seated with the knee at a 60-degree angle of flexion and instructed to push the leg forward against the device without moving the joint. This test measures the force generated by the quadriceps while the joint remains still. Assessments will be conducted by trained professionals using standardized procedures. Measurements will be performed when sedation is reduced or stopped so that the patient can respond to at least three motor commands (e.g., blink eyes, look at examiner, stick out tongue, shake head, raise eyebrows) to assess muscle strength at sedation awakening.
Isometric Knee Extension Strength Assessed at ICU Discharge	Within 24 hours after ICU discharge	Isometric knee extension strength will be assessed using a portable dynamometer. The participant will be seated with the knee positioned at a 60 degree angle of flexion and instructed to push the leg forward against the device without moving the joint. This test measures the force the quadriceps can generate while the joint remains still. The assessment will be conducted by trained professionals using standardized procedures.
Isometric Knee Extension Strength Assessed at Hospital Discharge	From 48 hours to 0 hours before hospital discharge	Isometric knee extension strength will be assessed using a portable dynamometer. The participant will be seated with the knee positioned at a 60 degree angle of flexion and instructed to push the leg forward against the device without moving the joint. This test measures the force the quadriceps can generate while the joint remains still. The assessment will be conducted by trained professionals using standardized procedures.
Functional capacity assessed by the Six-Minute Walk Test (6MWT)	From 48 hours to 0 hours before hospital discharge	The six-minute walk test (6MWT) will be conducted by trained physiotherapists to assess functional exercise capacity. The total distance walked in six minutes will be recorded following standardized procedures.
Barthel Index Assessed at Study Enrollment	At baseline (study enrollment)	Functional independence will be evaluated using the Barthel Index, a questionnaire that measures a patient's ability to perform activities of daily living (ADLs). At study enrollment, the questionnaire will be answered by the patient's family member or primary caregiver to provide a baseline assessment of the patient's functional status prior to ICU admission. The Barthel Index assesses independence in areas such as personal care, mobility, locomotion, and elimination. Each activity is scored based on the patient's level of independence, assistance needed, or dependence. Scores range from 0 to 100 in increments of five, with higher scores indicating greater functional independence.
Barthel Index Assessed at Hospital Discharge	From 48 hours to 0 hours before hospital discharge	Functional independence will be evaluated using the Barthel Index, a questionnaire that measures a patient's ability to perform activities of daily living (ADLs). The questionnaire assesses independence in areas such as personal care, mobility, locomotion, and elimination. Each activity is scored based on the patient's level of independence, assistance needed, or dependence. Scores range from 0 to 100 in increments of five, with higher scores indicating greater functional independence.
Barthel Index Assessed at 6 Months Post Hospital Discharge	6 months after hospital discharge	Functional independence will be evaluated using the Barthel Index, a questionnaire that measures a patient's ability to perform activities of daily living (ADLs). At 6 months post hospital discharge, the patient will be contacted by telephone to complete the questionnaire. The Barthel Index assesses independence in areas such as personal care, mobility, locomotion, and elimination. Each activity is scored based on the patient's level of independence, assistance needed, or dependence. Scores range from 0 to 100 in increments of five, with higher scores indicating greater functional independence.
Duration of invasive mechanical ventilation (IMV)	Within 24 hours after ICU discharge	The duration of invasive mechanical ventilation (IMV) will be measured from the initiation of IMV until the day of extubation. This duration will be verified and confirmed through review of the patient's medical records.
Ventilator-free days	Within 24 hours after ICU discharge	The number of days during which the patient was alive and free from invasive mechanical ventilation (IMV) during the ICU stay. This information will be collected from the patient's medical records at hospital discharge.
Length of stay in ICU and hospital	Within 24 hours after hospital discharge	The total number of days the patient remains admitted in the Intensive Care Unit (ICU) and the hospital during their treatment period. This includes the time from ICU admission until discharge from the hospital. This information will be collected from the patient's medical records at hospital discharge.
Mortality	From hospital admission until death or up to 180 days (6 months) after hospital discharge, whichever occurs first	The number of deaths occurring among study participants during the hospital stay and within six months after hospital discharge.

Trial Locations

Locations (1)

Hospital Moinhos de Vento; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil