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Studies

Interventional Recruiting

NCT07188350 on ClinicalTrials.gov

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

Official title: Neuromuscular Electrical Stimulation of Lower Limbs in Patients Undergoing Invasive Mechanical Ventilation: Randomized Clinical Trial

  • Sponsor: Hospital Moinhos de Vento
  • Collaborators: Federal University of Health Science of Porto Alegre
  • Enrollment: 150 (Estimated)
  • Study start: 2025-09-04 (Actual)
  • Primary completion: 2026-09-05 (Estimated)
  • Study completion: 2027-03-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: 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.
  • Masking: None
  • PrimaryPurpose: Treatment

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)

Intervention / Treatment

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

Primary Outcome Measures

  • 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.

Countries

Brazil

Locations and Investigators

Study Officials