Trial record 1 of 1 for:    NCT00709124
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Use of Neuromuscular Electrostimulation (NMES) for Treatment or Prevention of ICU-Associated Weakness

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00709124
First received: July 1, 2008
Last updated: March 20, 2012
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Intensive Care Unit
Muscle Weakness
Device: Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA)
Device: Sham
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Use of Neuromuscular Electrostimulation (NMES) for Treatment or Prevention of ICU-Associated Weakness

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Individual muscle strength: Pretibial, triceps surae, and quadriceps (MRC score) between those who receive NMES vs. sham sessions [ Time Frame: ICU and hospital discharge ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Overall body strength: Hand grip between those who receive NMES vs. sham sessions [ Time Frame: ICU and hospital discharge ] [ Designated as safety issue: No ]
  • Respiratory muscle strength: Maximum Inspiratory Pressure (MIP) between those who receive NMES vs. sham sessions [ Time Frame: ICU and hospital discharge ] [ Designated as safety issue: No ]
  • Functional status as measured by modified Functional Independence Measurement (FIM) score between those receiving NMES vs. sham sessions [ Time Frame: ICU and hospital discharge ] [ Designated as safety issue: No ]
  • Duration of mechanical ventilation [ Time Frame: At hospital discharge ] [ Designated as safety issue: No ]
  • ICU and hospital length of stay [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]
  • ICU and in-hospital mortality [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]
  • Total hospital charges [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]
  • Hospital discharge destination (e.g., home, rehab facility) [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Mean change in subject's lower extremity MRC composite score from baseline [ Time Frame: At ICU and Hospital discharge ] [ Designated as safety issue: No ]
  • ICU Delirium [ Time Frame: Number of days with delirium in the ICU ] [ Designated as safety issue: No ]
  • Subgroup analysis [ Time Frame: See description ] [ Designated as safety issue: No ]
    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 MRC score from baseline to ICU discharge, mean change in MRC score from baseline to hospital discharge, and composite whole body MRC score at ICU dischare and at hospital discharge.


Estimated Enrollment: 82
Study Start Date: June 2008
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NMES
60 minute daily NMES sessions every day for the duration of subject's ICU stay.
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)
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.
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)

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. We 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, we 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00709124

Contacts
Contact: Michelle Kho, PT, PhD (410) 502-2432 michelle.kho@jhmi.edu
Contact: Dale Needham, MD, PhD (410) 955-3467

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Michelle Kho, PT, PhD    410-502-2432    michelle.kho@jhmi.edu   
Sub-Investigator: Michelle Kho, PT, PhD         
Principal Investigator: Dale Needham, MD, PhD         
Sub-Investigator: Alex Truong, MD, MPH         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Dale Needham, MD, PhD Johns Hopkins University
  More Information

No publications provided by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dale Needham, MD, PhD / Associate Professor of Medicine, Johns Hopkins Hospital
ClinicalTrials.gov Identifier: NCT00709124     History of Changes
Other Study ID Numbers: NA_00017423
Study First Received: July 1, 2008
Last Updated: March 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Respiration, Artificial
Critical Illness
Intensive Care Units
Electric Stimulation Therapy
Muscle Weakness
Paresis
Mechanically
Ventilated
Patients
Admitted
Medical

Additional relevant MeSH terms:
Asthenia
Muscle Weakness
Paresis
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014