Neuromuscular Electrical Stimulation in a Patient on Invasive Mechanical Ventilation (MOVCARE)
NCT ID: NCT07188350
Last Updated: 2025-09-23
Study Results
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Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2025-09-04
2027-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Conventional Physical Therapy
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.
Conventional Physical Therapy
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 + Neuromuscular Electrical Stimulation
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 20 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.
Conventional Physical Therapy
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.
Neuromuscular Electrical Stimulation (NMES)
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.
Interventions
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Conventional Physical Therapy
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.
Neuromuscular Electrical Stimulation (NMES)
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Federal University of Health Science of Porto Alegre
OTHER
Hospital Moinhos de Vento
OTHER
Responsible Party
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Cassiano Teixeira
Professor Doutor
Principal Investigators
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Cassiano TEIXEIRA, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Moinhos de Vento
Locations
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Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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MOVCARE2025-LB
Identifier Type: -
Identifier Source: org_study_id
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