Use of Neuromuscular Electrostimulation (NMES) for Treatm... | NCT00709124

NCT00709124

Status Module

Sponsor/Collaborators Module

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Oversight Module

Description Module

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.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NMES	Experimental	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)
Sham	Sham Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA)	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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	At hospital discharge

Secondary Outcomes

Measure	Description	Time Frame
Individual Muscle Strength Using Handheld Dynamometry: Tibialis Anterior, Gastrocnemius, and Quadriceps Muscle Strength	Strength (in pounds) - measured via handheld dynamometry of tibialis anterior, gastrocnemius, and quadriceps	ICU and hospital discharge
Overall Body Strength

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Dale Needham, MD, PhD	Johns Hopkins University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins Hospital		Baltimore	Maryland	21287	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25307979	Derived	Kho ME, Truong AD, Zanni JM, Ciesla ND, Brower RG, Palmer JB, Needham DM. Neuromuscular electrical stimulation in mechanically ventilated patients: a randomized, sham-controlled pilot trial with blinded outcome assessment. J Crit Care. 2015 Feb;30(1):32-9. doi: 10.1016/j.jcrc.2014.09.014. Epub 2014 Sep 22.
22421734	Derived

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00016 BG00118 BG00234

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00054± 16 BG00156± 18 BG00255± 16

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0009 BG0018 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00016 BG00118 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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

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

Posted

Mean

Standard Deviation

units (range 0-30; higher is better)

At hospital discharge

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG00012 OG00117

Title

Denominators

Categories

Title	Measurements
	OG00028± 2 OG00127± 3

Secondary

Individual Muscle Strength Using Handheld Dynamometry: Tibialis Anterior, Gastrocnemius, and Quadriceps Muscle Strength

Strength (in pounds) - measured via handheld dynamometry of tibialis anterior, gastrocnemius, and quadriceps

Assessments can only be done on patients who were alive and were able to do participate in the assessment

Posted

Mean

Standard Deviation

pounds

ICU and hospital discharge

ID	Title	Description
OG000	Sham	60 minute sham sessions every day for the duration of subject's 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.
OG001	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.

Secondary

Overall Body Strength

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).

Assessments can only be done on patients who were alive and were able to do participate in the assessment

Posted

Mean

Standard Deviation

MRC Composite Score

ICU and hospital discharge

ID	Title	Description
OG000	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.
OG001	Sham	60 minute sham sessions every day for the duration of subject's 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.

Secondary

Hand Grip Strength

Hand grip strength measured using a dynamometer (measured in kilograms, then compared to age- and sex-matched population norms to yield % predicted)

Assessments can only be done on patients who were alive and were able to do participate in the assessment

Posted

Mean

Standard Deviation

% predicted

ICU and hospital discharge

ID	Title	Description
OG000	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.
OG001	Sham	60 minute sham sessions every day for the duration of subject's 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.

Secondary

Respiratory Muscle Strength

Measured using maximal inspiratory pressure (MIP) measurements that is then compared to predicted values for each participant (i.e., % predicted)

Assessments can only be done on patients who were alive and were able to do participate in the assessment

Posted

Mean

Standard Deviation

% predicted

ICU and hospital discharge

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Functional Status Measured Using Functional Status Score for the Intensive Care Unit

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.

Assessments can only be done on patients who were alive and were able to do participate in the assessment

Posted

Mean

Standard Deviation

FSS-ICU Score

ICU and hospital discharge

ID	Title	Description
OG000	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.
OG001	Sham	60 minute sham sessions every day for the duration of subject's 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.

Secondary

Duration of Mechanical Ventilation

The number of days the patient was on mechanical ventilation.

Posted

Mean

Standard Deviation

days

Until hospital discharge

ID	Title	Description
OG000	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.
OG001	Sham	60 minute sham sessions every day for the duration of subject's 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.

Units	Counts
Participants

Secondary

ICU and Hospital Length of Stay

The number of days that the patient was in the ICU and hospital, respectively.

Posted

Mean

Standard Deviation

days

ICU and Hospital discharge

ID	Title	Description
OG000	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.
OG001	Sham	60 minute sham sessions every day for the duration of subject's 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.

Units	Counts
Participants

Secondary

ICU and In-hospital Mortality

The number of patients who died in the ICU and those who died by hospital discharge.

Posted

Count of Participants

Participants

ICU discharge and Hospital discharge

ID	Title	Description
OG000	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.
OG001	Sham	60 minute sham sessions every day for the duration of subject's 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.

Units	Counts
Participants

Secondary

Total Hospital Charges

The total dollar amount of charges from hospital stay

Posted

Mean

Standard Deviation

US dollars

Hospital discharge

ID	Title	Description
OG000	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.
OG001	Sham	60 minute sham sessions every day for the duration of subject's 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.

Units	Counts
Participants

Secondary

Hospital Discharge Destination (e.g., Home, Rehab Facility)

Discharge location after hospital stay.

Assessments can only be done on patients who were alive and were able to do participate in the assessment

Posted

Count of Participants

Participants

Hospital discharge

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

Secondary

Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps)

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)

Assessments can only be done on patients who were alive and were able to do participate in the assessment

Posted

Mean

Standard Deviation

MRC Score

At hospital discharge

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Mean Change in Subject's Lower Extremity Muscle Strength Composite Score From Baseline

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).

Assessments can only be done on patients who were alive and were able to do participate in the assessment

Posted

Mean

Standard Deviation

MRC Score

At ICU and Hospital discharge

ID	Title	Description
OG000	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.
OG001	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.

Secondary

ICU Delirium

Proportion of ICU days the patient had delirium

Posted

Mean

Standard Deviation

Mean % delirious days

During ICU stay - on days with study (NMES/Sham) session

Days of session

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Subgroup Analysis

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.

This was an a priori subgroup analyses of patients who had mechanical ventilation duration >=7 days. Not all participants could be evaluated at each time point (e.g. cognitive status) and this explains the different sample sizes for each outcome.

Posted

Mean

Standard Deviation

muscle strength score (higher is better)

ICU and hospital discharge and change over time

ID	Title	Description
OG000	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.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.			0	16	0	16
EG001	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.			0	18	0	18

ID	Term
D018908	Muscle Weakness
D053120	Respiratory Aspiration
D016638	Critical Illness
D010291	Paresis

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012816	Signs and Symptoms
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020969	Disease Attributes

Units	Counts
Participants	OG00012 OG00117