title: Neuromuscular electrical stimulation in mechanically ventilated patients: a randomized, sham-controlled pilot trial with blinded outcome assessment.
abstract: OBJECTIVE
  The purpose of the study is to compare neuromuscular electrical stimulation (NMES) vs sham on leg strength at hospital discharge in mechanically ventilated patients.
  
  
  METHODS
  We conducted a randomized pilot study of NMES vs sham applied to 3 bilateral lower extremity muscle groups for 60 minutes daily in the intensive care unit (ICU). Between June 2008 and March 2013, we enrolled adults who were receiving mechanical ventilation within the first week of ICU stay and who could transfer independently from bed to chair before hospital admission. The primary outcome was lower extremity muscle strength at hospital discharge using Medical Research Council score (maximum, 30). Secondary outcomes at hospital discharge included walking distance and change in lower extremity strength from ICU awakening. Clinicaltrials.gov: NCT00709124.
  
  
  RESULTS
  We stopped enrollment early after 36 patients due to slow patient accrual and the end of research funding. For NMES vs sham, mean (SD) lower extremity strength was 28 (2) vs 27 (3), P = .072. Among secondary outcomes, NMES vs sham patients had a greater mean (SD) walking distance (514 [389] vs 251 [210] ft, P = .050) and increase in muscle strength (5.7 [5.1] vs 1.8 [2.7], P = .019).
  
  
  CONCLUSIONS
  In this pilot randomized trial, NMES did not significantly improve leg strength at hospital discharge. Significant improvements in secondary outcomes require investigation in future research.
authors.affiliation: Department of Physical Medicine and Rehabilitation, Johns Hopkins University, Baltimore, MD 21287; School of Rehabilitation Science, McMaster University, Hamilton, ON, Canada L8S 1C7. Electronic address: khome@mcmaster.ca.
authors.forename: Michelle E
authors.initials: ME
authors.lastname: Kho
authors.affiliation: Pulmonary, Allergy, and Critical Care Medicine, Emory University, Atlanta, GA 30308.
authors.forename: Alexander D
authors.initials: AD
authors.lastname: Truong
authors.affiliation: Department of Physical Medicine and Rehabilitation, Johns Hopkins University, Baltimore, MD 21287; Department of Physical Medicine and Rehabilitation, Johns Hopkins Hospital, Baltimore, MD 21287; Outcomes After Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, MD 21287.
authors.forename: Jennifer M
authors.initials: JM
authors.lastname: Zanni
authors.affiliation: Division of Pulmonary and Critical Care Medicine, Johns Hopkins University, Baltimore, MD 21287; Outcomes After Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, MD 21287.
authors.forename: Nancy D
authors.initials: ND
authors.lastname: Ciesla
authors.affiliation: Division of Pulmonary and Critical Care Medicine, Johns Hopkins University, Baltimore, MD 21287.
authors.forename: Roy G
authors.initials: RG
authors.lastname: Brower
authors.affiliation: Department of Physical Medicine and Rehabilitation, Johns Hopkins University, Baltimore, MD 21287.
authors.forename: Jeffrey B
authors.initials: JB
authors.lastname: Palmer
authors.affiliation: Department of Physical Medicine and Rehabilitation, Johns Hopkins University, Baltimore, MD 21287; Division of Pulmonary and Critical Care Medicine, Johns Hopkins University, Baltimore, MD 21287; Outcomes After Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, MD 21287.
authors.forename: Dale M
authors.initials: DM
authors.lastname: Needham
mesh_terms: D000328:Adult; D000368:Aged; D057239:Early Termination of Clinical Trials; D004558:Electric Stimulation; D004599:Electric Stimulation Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D007362:Intensive Care Units; D035002:Lower Extremity / Q000502:physiology; D008297:Male; D008875:Middle Aged; D053580:Muscle Strength / Q000502:physiology*; D017063:Outcome Assessment, Health Care; D010351:Patient Discharge; D018579:Patient Selection; D010865:Pilot Projects; D012121:Respiration, Artificial; D013997:Time Factors; D016138:Walking
keywords: Critical illness; Electric stimulation; Intensive care units; Muscle; Randomized controlled trial; Respiration artificial