title: Neuromuscular electrical stimulation for intensive care unit-acquired weakness: protocol and methodological implications for a randomized, sham-controlled, phase II trial.
abstract: BACKGROUND
  As the population ages and critical care advances, a growing number of survivors of critical illness will be at risk for intensive care unit (ICU)-acquired weakness. Bed rest, which is common in the ICU, causes adverse effects, including muscle weakness. Consequently, patients need ICU-based interventions focused on the muscular system. Although emerging evidence supports the benefits of early rehabilitation during mechanical ventilation, additional therapies may be beneficial. Neuromuscular electrical stimulation (NMES), which can provide some muscular activity even very early during critical illness, is a promising modality for patients in the ICU.
  
  
  OBJECTIVE
  The objectives of this article are to discuss the implications of bed rest for patients with critical illness, summarize recent studies of early rehabilitation and NMES in the ICU, and describe a protocol for a randomized, phase II pilot study of NMES in patients receiving mechanical ventilation.
  
  
  METHODS
  The study was a randomized, sham-controlled, concealed, phase II pilot study with caregivers and outcome assessors blinded to the treatment allocation.
  
  
  METHODS
  The study setting will be a medical ICU.
  
  
  METHODS
  The study participants will be patients who are receiving mechanical ventilation for 1 day or more, who are expected to stay in the ICU for an additional 2 days or more, and who meet no exclusion criteria.
  
  
  METHODS
  The intervention will be NMES (versus a sham [control] intervention) applied to the quadriceps, tibialis anterior, and gastrocnemius muscles for 60 minutes per day.
  
  
  METHODS
  Lower-extremity muscle strength at hospital discharge will be the primary outcome measure.
  
  
  CONCLUSIONS
  Muscle strength is a surrogate measure, not a patient-centered outcome. The assessments will not include laboratory, genetic, or histological measures aimed at a mechanistic understanding of NMES. The optimal duration or dose of NMES is unclear.
  
  
  CONCLUSIONS
  If NMES is beneficial, the results of the study will help advance research aimed at reducing the burden of muscular weakness and physical disability in survivors of critical illness.
authors.affiliation: Department of Physical Medicine and Rehabilitation, Johns Hopkins University, Phipps 197, 600 N Wolfe St, Baltimore, MD 21287, USA.
authors.forename: Michelle E
authors.initials: ME
authors.lastname: Kho
authors.forename: Alexander D
authors.initials: AD
authors.lastname: Truong
authors.forename: Roy G
authors.initials: RG
authors.lastname: Brower
authors.forename: Jeffrey B
authors.initials: JB
authors.lastname: Palmer
authors.forename: Eddy
authors.initials: E
authors.lastname: Fan
authors.forename: Jennifer M
authors.initials: JM
authors.lastname: Zanni
authors.forename: Nancy D
authors.initials: ND
authors.lastname: Ciesla
authors.forename: Dorianne R
authors.initials: DR
authors.lastname: Feldman
authors.forename: Radha
authors.initials: R
authors.lastname: Korupolu
authors.forename: Dale M
authors.initials: DM
authors.lastname: Needham
mesh_terms: D001510:Bed Rest / Q000009:adverse effects*; D016638:Critical Illness / Q000534:rehabilitation*; D004599:Electric Stimulation Therapy; D006801:Humans; D007362:Intensive Care Units; D035002:Lower Extremity / Q000503:physiopathology; D053580:Muscle Strength / Q000502:physiology; D053581:Muscle Strength Dynamometer; D018908:Muscle Weakness / Q000503:physiopathology / Q000628:therapy*; D010865:Pilot Projects; D012107:Research Design