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Clinical Trials/NCT03083652
NCT03083652
Recruiting
Not Applicable

Effects of Neuromuscular Electrical Stimulation on Exercise Capacity in Respiratory Critically Ill Patients

Hospital Clinic of Barcelona1 site in 1 country40 target enrollmentFebruary 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Critical Illness Myopathy
Sponsor
Hospital Clinic of Barcelona
Enrollment
40
Locations
1
Primary Endpoint
Exercise capacity
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Neuromuscular electrical stimulation (NMES) implemented during the intensive care unit(ICU) stay may improve exercise capacity and prevent muscular weakness in critically ill patients with respiratory disease. Main objective: To evaluate, in respiratory critically ill patients, the effects of a conventional physiotherapy program with or without additional NMES applied only during the ICU stay on exercise capacity. Design: Randomized, controlled, double-blind clinical trial on patients (>18yo) with diagnosis on admission of acute or acute on chronic respiratory disease, on mechanical ventilation (MV) > 72h and expected MV > 24h. Intervention: Conventional physiotherapy with or without 30-minutes (5days/week) on quadriceps femoris and gluteus maximus. Patients in the control group will follow the same protocol but the device will not be activated. Measures: Demographic data, body composition through bioelectrical impedance analysis (BIA), and functional capacity before admission through Barthel scale will be registered upon inclusion. Exercise capacity through test sit-to stand, muscular strength through Medical Research Council (MRC) score and dynamometry, body composition through BIA, and functional capacity through Barthel scale will be obtained at ICU and hospital discharge.

Registry
clinicaltrials.gov
Start Date
February 1, 2017
End Date
June 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joan-Daniel Martí Romeu

Principal Investigator

Hospital Clinic of Barcelona

Eligibility Criteria

Inclusion Criteria

  • Diagnosis at admission: acute or acute on chronic respiratory disease
  • Mechanical ventilation \> 72h at inclusion
  • Expected mechanical ventilation \> 24h
  • Informed consent

Exclusion Criteria

  • Patients re-admitted to ICU (no hospital discharge)
  • Exitus or transfer to another service/hospital
  • Respiratory instability \[Inspired fraction of oxygen (FIO2) \>60% or positive end-expiratory pressure (PEEP) \>10 cmH2O\] and/or hemodynamic instability \[Mean arterial pressure ( MAP)\<60mmHg although vasoactive drugs\] during \> 24h.
  • Pregnancy
  • Neuromuscular disease before admission
  • Skin lesions
  • Limitation of therapeutic effort
  • Mental and/or physical limitation to understand/realize tests for evaluation

Outcomes

Primary Outcomes

Exercise capacity

Time Frame: 24h before hospital discharge

Test sit-to-stand

Secondary Outcomes

  • Muscle strength(24h before hospital discharge)
  • Body composition (fat free mass)(24h before hospital discharge)
  • Functional Capacity(24h before hospital discharge)

Study Sites (1)

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