ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00709124
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (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

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2 patients (both randomized to the intervention group) were withdrawn PRIOR to any initiation of intervention due to new data arising after randomization (and before intervention initiation) that indicated the subject met the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

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) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      9  56.3%      8  44.4%      17  50.0% 
Male      7  43.8%      10  55.6%      17  50.0% 
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 Using Handheld Dynamometry: Tibialis Anterior, Gastrocnemius, and Quadriceps Muscle Strength   [ Time Frame: ICU and hospital discharge ]

3.  Secondary:   Overall Body Strength   [ Time Frame: ICU and hospital discharge ]

4.  Secondary:   Hand Grip Strength   [ Time Frame: ICU and hospital discharge ]

5.  Secondary:   Respiratory Muscle Strength   [ Time Frame: ICU and hospital discharge ]

6.  Secondary:   Functional Status Measured Using Functional Status Score for the Intensive Care Unit   [ Time Frame: ICU and hospital discharge ]

7.  Secondary:   Duration of Mechanical Ventilation   [ Time Frame: Until hospital discharge ]

8.  Secondary:   ICU and Hospital Length of Stay   [ Time Frame: ICU and Hospital discharge ]

9.  Secondary:   ICU and In-hospital Mortality   [ Time Frame: ICU discharge and Hospital discharge ]

10.  Secondary:   Total Hospital Charges   [ Time Frame: Hospital discharge ]

11.  Secondary:   Hospital Discharge Destination (e.g., Home, Rehab Facility)   [ Time Frame: Hospital discharge ]

12.  Secondary:   Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps)   [ Time Frame: At hospital discharge ]

13.  Secondary:   Mean Change in Subject’s Lower Extremity Muscle Strength Composite Score From Baseline   [ Time Frame: At ICU and Hospital discharge ]

14.  Secondary:   ICU Delirium   [ Time Frame: During ICU stay - on days with study (NMES/Sham) session ]

15.  Secondary:   Subgroup Analysis   [ Time Frame: ICU and hospital discharge and change over time ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00709124     History of Changes
Other Study ID Numbers: NA_00017423
First Submitted: July 1, 2008
First Posted: July 3, 2008
Results First Submitted: March 30, 2015
Results First Posted: April 16, 2015
Last Update Posted: January 23, 2018