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

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Dale Needham, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00709124
First received: July 1, 2008
Last updated: April 13, 2015
Last verified: April 2015
Results First Received: March 30, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Intensive Care Unit
Muscle Weakness
Interventions: Device: Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA)
Device: Sham

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
3 medical and surgical ICUs at Johns Hopkins Hospitals screened for recruitment from 2008-2009 and 2010-2013 (39 months in total). Recruitment suspended for 17 consecutive months between 2009-2010 due to lack of staffing

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
2 patients (both randomized to the intervention group) were withdrawn PRIOR to any initiation of intervention due to new data arising after randomization (and before intervention initiation) that indicated the subject met the pre-existing exclusion criteria.

Reporting Groups
  Description
NMES

60 minute daily NMES sessions every day for the duration of subject's ICU stay.

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.

Sham

60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.

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.


Participant Flow:   Overall Study
    NMES   Sham
STARTED   16   18 
COMPLETED   12   17 
NOT COMPLETED   4   1 
Death                3                1 
encephalopathy; can't do assessment                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
NMES

60 minute daily NMES sessions every day for the duration of subject's ICU stay.

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.

Sham

60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.

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.

Total Total of all reporting groups

Baseline Measures
   NMES   Sham   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   18   34 
Age 
[Units: Years]
Mean (Standard Deviation)
 54  (16)   56  (18)   55  (16) 
Gender 
[Units: Participants]
     
Female   9   8   17 
Male   7   10   17 
Region of Enrollment 
[Units: Participants]
     
United States   16   18   34 


  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Individual Muscle Strength: Pretibial, Triceps Surae, and Quadriceps (MRC Score) Between Those Who Receive NMES vs. Sham Sessions   [ Time Frame: ICU and hospital discharge ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Overall Body Strength: Hand Grip Between Those Who Receive NMES vs. Sham Sessions   [ Time Frame: ICU and hospital discharge ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Respiratory Muscle Strength: Maximum Inspiratory Pressure (MIP) Between Those Who Receive NMES vs. Sham Sessions   [ Time Frame: ICU and hospital discharge ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Functional Status as Measured by Modified Functional Independence Measurement (FIM) Score Between Those Receiving NMES vs. Sham Sessions   [ Time Frame: ICU and hospital discharge ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Duration of Mechanical Ventilation   [ Time Frame: At hospital discharge ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   ICU and Hospital Length of Stay   [ Time Frame: Hospital discharge ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   ICU and In-hospital Mortality   [ Time Frame: Hospital discharge ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Total Hospital Charges   [ Time Frame: Hospital discharge ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Hospital Discharge Destination (e.g., Home, Rehab Facility)   [ Time Frame: Hospital discharge ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

12.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

13.  Secondary:   Mean Change in Subject’s Lower Extremity MRC Composite Score From Baseline   [ Time Frame: At ICU and Hospital discharge ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

14.  Secondary:   ICU Delirium   [ Time Frame: Number of days with delirium in the ICU ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

15.  Secondary:   Subgroup Analysis   [ Time Frame: See description ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Dale Needham
Organization: Johns Hopkins University School of Medicine
phone: (410) 955-3467
e-mail: dale.needham@jhmi.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dale Needham, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00709124     History of Changes
Other Study ID Numbers: NA_00017423
Study First Received: July 1, 2008
Results First Received: March 30, 2015
Last Updated: April 13, 2015
Health Authority: United States: Institutional Review Board