Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-29 @ 5:03 AM
Study NCT ID:
NCT07188350
Status:
RECRUITING
Last Update Posted:
2025-09-23
First Post:
2025-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuromuscular Electrical Stimulation in a Patient on Invasive Mechanical Ventilation (MOVCARE)
Sponsor:
Hospital Moinhos de Vento
Organization:
Study Overview
Official Title:
Neuromuscular Electrical Stimulation of Lower Limbs in Patients Undergoing Invasive Mechanical Ventilation: Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MOVCARE
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: