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Use of Neuromuscular Electrostimulation (NMES) for Treatment or Prevention of ICU-Associated Weakness (NMES)

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ClinicalTrials.gov Identifier: NCT00709124
Recruitment Status : Completed
First Posted : July 3, 2008
Results First Posted : April 16, 2015
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE July 1, 2008
First Posted Date  ICMJE July 3, 2008
Results First Submitted Date  ICMJE March 30, 2015
Results First Posted Date  ICMJE April 16, 2015
Last Update Posted Date January 23, 2018
Study Start Date  ICMJE June 2008
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2015)
Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps) Measured Via MMT Using a Composite Medical Research Council (MRC) Score [ Time Frame: At hospital discharge ]
Range 0 to 30 with higher score better. The composite score is a simple sum of the individual scores from the 3 bilateral muscle groups
Original Primary Outcome Measures  ICMJE
 (submitted: July 2, 2008)
Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps) Measured Via MMT Using a Composite Medical Research Council (MRC) Score [ Time Frame: At hospital discharge ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2018)
  • Individual Muscle Strength Using Handheld Dynamometry: Tibialis Anterior, Gastrocnemius, and Quadriceps Muscle Strength [ Time Frame: ICU and hospital discharge ]
    Strength (in pounds) - measured via handheld dynamometry of tibialis anterior, gastrocnemius, and quadriceps
  • Overall Body Strength [ Time Frame: ICU and hospital discharge ]
    Measuring strength of 6 muscle groups in arms and legs using Medical Research Council composite score (each muscle group scored from scale of 0 [no visible or noticeable contraction] to 5 [maximum strength] and the sum of the scores for the 6 muscle groups equate to a composite score ranging from 0 to 60, higher score is better).
  • Hand Grip Strength [ Time Frame: ICU and hospital discharge ]
    Hand grip strength measured using a dynamometer (measured in kilograms, then compared to age- and sex-matched population norms to yield % predicted)
  • Respiratory Muscle Strength [ Time Frame: ICU and hospital discharge ]
    Measured using maximal inspiratory pressure (MIP) measurements that is then compared to predicted values for each participant (i.e., % predicted)
  • Functional Status Measured Using Functional Status Score for the Intensive Care Unit [ Time Frame: ICU and hospital discharge ]
    Evaluates a patient's physical function in the ICU setting. Each task is scored, ranging from 0 (unable to perform) to 7 (complete independence).The total score ranges from 0-35, with higher scores indicating better physical functioning.
  • Duration of Mechanical Ventilation [ Time Frame: Until hospital discharge ]
    The number of days the patient was on mechanical ventilation.
  • ICU and Hospital Length of Stay [ Time Frame: ICU and Hospital discharge ]
    The number of days that the patient was in the ICU and hospital, respectively.
  • ICU and In-hospital Mortality [ Time Frame: ICU discharge and Hospital discharge ]
    The number of patients who died in the ICU and those who died by hospital discharge.
  • Total Hospital Charges [ Time Frame: Hospital discharge ]
    The total dollar amount of charges from hospital stay
  • Hospital Discharge Destination (e.g., Home, Rehab Facility) [ Time Frame: Hospital discharge ]
    Discharge location after hospital stay.
  • Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps) [ Time Frame: At hospital discharge ]
    Measured via manual muscle strength test using a composite Medical Research Council (MRC) score with each muscle group rated with score ranging from 0 (no visible or noticeable contraction of the muscle) to 5 (maximum strength). The sum of the scores for the lower limb muscle groups can range from 0 to 30 (higher score is better)
  • Mean Change in Subject's Lower Extremity Muscle Strength Composite Score From Baseline [ Time Frame: At ICU and Hospital discharge ]
    The mean change of the sum of the lower limb strength scores between awakening and ICU discharge and between ICU discharge and hospital discharge. Three lower limb muscle groups are assessed bilaterally (each muscle group scored from scale of 0 [no visible or noticeable contraction] to 5 [maximum strength]). The scores are then summed for each patient at each time point (range 0 -30, higher score is better).
  • ICU Delirium [ Time Frame: During ICU stay - on days with study (NMES/Sham) session ]
    Proportion of ICU days the patient had delirium
  • Subgroup Analysis [ Time Frame: ICU and hospital discharge and change over time ]
    For patients with >= 7 days of mechanical ventilation, we will compare the 2 groups for the following outcomes: Lower extremity muscle strength, mean change in whole body muscle strength score from baseline to ICU discharge, mean change in whole body muscle strength score from baseline to hospital discharge, and whole body muscle strength score at ICU discharge and at hospital discharge. Each muscle group is assessed bilaterally (scale of 0 [no visible or noticeable contraction] to 5 [maximum strength]). There are three muscle groups assessed bilaterally for lower extremity (hip flexion, knee extension, and ankle dorsiflexion) (score range 0-30, higher score is better i.e. stronger); while for whole body strength assessment (score range 0-360, higher score is better), the following additional muscles are assessed: shoulder abduction, elbow flexion and wrist extension. The scores are then summed for each patient at each time point.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2008)
  • Individual Muscle Strength: Pretibial, Triceps Surae, and Quadriceps (MRC Score) Between Those Who Receive NMES vs. Sham Sessions [ Time Frame: ICU and hospital discharge ]
  • Overall Body Strength: 6 Bilateral Muscle Groups in Arms and Legs (MRC Composite Score) Between Those Who Receive NMES vs. Sham Sessions [ Time Frame: ICU and hospital discharge ]
  • Overall Body Strength: Hand Grip Between Those Who Receive NMES vs. Sham Sessions [ Time Frame: ICU and hospital discharge ]
  • Respiratory Muscle Strength: Maximum Inspiratory Pressure (MIP) Between Those Who Receive NMES vs. Sham Sessions [ Time Frame: ICU and hospital discharge ]
  • Functional Status as Measured by Modified Functional Independence Measurement (FIM) Score Between Those Receiving NMES vs. Sham Sessions [ Time Frame: ICU and hospital discharge ]
  • Duration of Mechanical Ventilation [ Time Frame: At hospital discharge ]
  • ICU and Hospital Length of Stay [ Time Frame: Hospital discharge ]
  • ICU and In-hospital Mortality [ Time Frame: Hospital discharge ]
  • Total Hospital Charges [ Time Frame: Hospital discharge ]
  • Hospital Discharge Destination (e.g., Home, Rehab Facility) [ Time Frame: Hospital discharge ]
  • Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps) Measured Via MMT Using a Composite Medical Research Council (MRC) Score [ Time Frame: At ICU discharge ]
  • Mean Change in Subject's Lower Extremity MRC Composite Score From Baseline [ Time Frame: At ICU and Hospital discharge ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Neuromuscular Electrostimulation (NMES) for Treatment or Prevention of ICU-Associated Weakness
Official Title  ICMJE Use of Neuromuscular Electrostimulation (NMES) for Treatment or Prevention of ICU-Associated Weakness
Brief Summary The purpose of this study is to investigate whether neuromuscular electrostimulation (NMES) will decrease ICU-associated weakness. The investigators believe that 60 minutes of daily NMES will improve strength and function in those who have had extended ICU stays, as well as decrease critical illness myopathy as an etiology of weakness in the critically ill.
Detailed Description Survivors of critical illness frequently have significant, debilitating and persistent weakness after discharge from the intensive care unit (ICU). This weakness can persist for up to 4 years after ICU discharge. There are few interventions that have been successful in reducing or preventing weakness. Neuromuscular electrostimulation (NMES) therapy is beneficial in other populations of weak and functionally limited patients, such as those with chronic respiratory failure requiring mechanical ventilation, severe chronic obstructive pulmonary disease and end-stage congestive heart failure. We propose a randomized clinical trial to evaluate the efficacy of 60 minutes of NMES versus sham therapy, applied to the bilateral lower extremities, to reduce ICU-associated weakness in patients with acute respiratory failure. Our specific aims are to determine if NMES therapy will: 1) increase strength of the 3 treated lower extremity muscle groups (i.e., pretibial, triceps surae, and quadriceps), 2) improve important clinical outcomes (i.e., functional status, duration of mechanical ventilation, length of ICU and hospital stay, in-hospital mortality, and total hospital charges), 3) reduce critical illness myopathy as an etiology of weakness in clinically weak ICU patients. The investigators hypothesize that NMES therapy will reduce ICU-associated weakness, and improve clinical and functional outcomes. Additionally, the rates of critical illness myopathy as an etiology of weakness in clinically weak ICU patients will be lower in those receiving NMES versus sham therapy. Since there is no single test that is optimal for measuring muscle strength in the critically ill, the investigators will employ four non-invasive measures: manual muscle testing (MMT), hand held dynamometry (HHD), handgrip dynamometry (HGD), and maximal inspiratory pressure (MIP). With no existing therapeutic options available, our study explores the potential of NMES as a feasible intervention to reduce ICU-associated weakness.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Intensive Care Unit
  • Muscle Weakness
Intervention  ICMJE
  • Device: Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA)
    60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay.
    Other Name: CareStim Muscle Stimulation Device (Care Rehab; McLean, VA)
  • Device: Sham
    60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied.
    Other Name: CareStim Muscle Stimulation Device (Care Rehab; McLean, VA)
Study Arms  ICMJE
  • Experimental: NMES
    60 minute daily NMES sessions every day for the duration of subject's ICU stay.
    Intervention: Device: Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA)
  • Sham Comparator: Sham
    60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.
    Intervention: Device: Sham
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 13, 2015)
36
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2008)
82
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1 day of mechanical ventilation with an expectation of requiring ≥2 additional days of ICU stay in a Johns Hopkins Intensive Care Unit (ICU)

Exclusion Criteria:

  • Unable to understand or speak English due to language barrier or cognitive impairment prior to admission
  • Unable to independently transfer from bed to chair at baseline prior to hospital admission
  • Known primary systemic neuromuscular disease (e.g. Guillian-Barre) at ICU admission
  • Known intracranial process that is associated with localizing weakness (e.g. cerebral vascular accident) at ICU admission
  • Transferred from another ICU outside of the Johns Hopkins system after >4 consecutive days of mechanical ventilation
  • Moribund (i.e. >90% probability of patient mortality in the next 96 hours)
  • Anticipated transfer to another ICU for care (e.g. awaiting organ transplantation and transfer to surgical ICU)
  • Any pacemaker (e.g., cardiac, diaphragm) or implanted cardiac defibrillator
  • Pregnancy
  • Body mass index ≥35 kg/m2
  • Any limitation in life support other than a sole no-CPR order
  • Known or suspected malignancy in the legs
  • Unable to treat or evaluate both lower extremities (e.g., bilateral amputation, bilateral skin lesions)
  • ICU length of stay >7 days prior to enrollment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00709124
Other Study ID Numbers  ICMJE NA_00017423
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Dale Needham, MD, PhD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP