Intensive Care Unit, Muscle Weakness
Conditions
Keywords
Respiration, Artificial, Critical Illness, Intensive Care Units, Electric Stimulation Therapy, Muscle Weakness, Paresis, Mechanically, Ventilated, Patients, Admitted, Medical
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.
Interventions
DEVICENeuromuscular 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.
DEVICESham
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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Body Strength | 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 | 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 | 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 | 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 | Until hospital discharge | The number of days the patient was on mechanical ventilation. |
| ICU and Hospital Length of Stay | ICU and Hospital discharge | The number of days that the patient was in the ICU and hospital, respectively. |
| Individual Muscle Strength Using Handheld Dynamometry: Tibialis Anterior, Gastrocnemius, and Quadriceps Muscle Strength | ICU and hospital discharge | Strength (in pounds) - measured via handheld dynamometry of tibialis anterior, gastrocnemius, and quadriceps |
| Total Hospital Charges | Hospital discharge | The total dollar amount of charges from hospital stay |
| Hospital Discharge Destination (e.g., Home, Rehab Facility) | Hospital discharge | Discharge location after hospital stay. |
| Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps) | 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 | 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 | During ICU stay - on days with study (NMES/Sham) session | Proportion of ICU days the patient had delirium |
| Subgroup Analysis | 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. |
| ICU and In-hospital Mortality | ICU discharge and Hospital discharge | The number of patients who died in the ICU and those who died by hospital discharge. |
Countries
United States
Participant flow
Recruitment details
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
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| 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. | 18 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 1 |
| Overall Study | encephalopathy; can't do assessment | 1 | 0 |
Baseline characteristics
| Characteristic | NMES | Sham | Total |
|---|---|---|---|
| Age, Continuous | 54 years STANDARD_DEVIATION 16 | 56 years STANDARD_DEVIATION 18 | 55 years STANDARD_DEVIATION 16 |
| Region of Enrollment United States | 16 participants | 18 participants | 34 participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 17 Participants |
| Sex: Female, Male Male | 7 Participants | 10 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 18 |
| serious Total, serious adverse events | 0 / 16 | 0 / 18 |
Outcome results
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
Time frame: At hospital discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NMES | 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 | 28 units (range 0-30; higher is better) | Standard Deviation 2 |
| Sham | 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 | 27 units (range 0-30; higher is better) | Standard Deviation 3 |
Secondary
Duration of Mechanical Ventilation
The number of days the patient was on mechanical ventilation.
Time frame: Until hospital discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NMES | Duration of Mechanical Ventilation | 20 days | Standard Deviation 18 |
| Sham | Duration of Mechanical Ventilation | 16 days | Standard Deviation 15 |
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.
Time frame: ICU and hospital discharge
Population: Assessments can only be done on patients who were alive and were able to do participate in the assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NMES | Functional Status Measured Using Functional Status Score for the Intensive Care Unit | ICU Discharge | 20 FSS-ICU Score | Standard Deviation 10 |
| NMES | Functional Status Measured Using Functional Status Score for the Intensive Care Unit | Hospital Discharge | 30 FSS-ICU Score | Standard Deviation 7 |
| Sham | Functional Status Measured Using Functional Status Score for the Intensive Care Unit | ICU Discharge | 19 FSS-ICU Score | Standard Deviation 6 |
| Sham | Functional Status Measured Using Functional Status Score for the Intensive Care Unit | Hospital Discharge | 26 FSS-ICU Score | Standard Deviation 8 |
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)
Time frame: ICU and hospital discharge
Population: Assessments can only be done on patients who were alive and were able to do participate in the assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NMES | Hand Grip Strength | ICU Discharge | 34 % predicted | Standard Deviation 26 |
| NMES | Hand Grip Strength | Hospital Discharge | 46 % predicted | Standard Deviation 25 |
| Sham | Hand Grip Strength | Hospital Discharge | 40 % predicted | Standard Deviation 28 |
| Sham | Hand Grip Strength | ICU Discharge | 41 % predicted | Standard Deviation 42 |
Secondary
Hospital Discharge Destination (e.g., Home, Rehab Facility)
Discharge location after hospital stay.
Time frame: Hospital discharge
Population: Assessments can only be done on patients who were alive and were able to do participate in the assessment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NMES | Hospital Discharge Destination (e.g., Home, Rehab Facility) | Other | 4 Participants |
| NMES | Hospital Discharge Destination (e.g., Home, Rehab Facility) | Home | 5 Participants |
| NMES | Hospital Discharge Destination (e.g., Home, Rehab Facility) | Acute rehabilitation | 4 Participants |
| Sham | Hospital Discharge Destination (e.g., Home, Rehab Facility) | Other | 1 Participants |
| Sham | Hospital Discharge Destination (e.g., Home, Rehab Facility) | Home | 8 Participants |
| Sham | Hospital Discharge Destination (e.g., Home, Rehab Facility) | Acute rehabilitation | 6 Participants |
Secondary
ICU and Hospital Length of Stay
The number of days that the patient was in the ICU and hospital, respectively.
Time frame: ICU and Hospital discharge
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NMES | ICU and Hospital Length of Stay | ICU Length of Stay | 22 days | Standard Deviation 17 |
| NMES | ICU and Hospital Length of Stay | Hospital Length of Stay | 36 days | Standard Deviation 22 |
| Sham | ICU and Hospital Length of Stay | ICU Length of Stay | 20 days | Standard Deviation 17 |
| Sham | ICU and Hospital Length of Stay | Hospital Length of Stay | 35 days | Standard Deviation 20 |
Secondary
ICU and In-hospital Mortality
The number of patients who died in the ICU and those who died by hospital discharge.
Time frame: ICU discharge and Hospital discharge
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NMES | ICU and In-hospital Mortality | ICU Mortality | 3 Participants |
| NMES | ICU and In-hospital Mortality | Hospital Mortality | 3 Participants |
| Sham | ICU and In-hospital Mortality | ICU Mortality | 1 Participants |
| Sham | ICU and In-hospital Mortality | Hospital Mortality | 3 Participants |
Secondary
ICU Delirium
Proportion of ICU days the patient had delirium
Time frame: During ICU stay - on days with study (NMES/Sham) session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NMES | ICU Delirium | 67 Mean % delirious days | Standard Deviation 34 |
| Sham | ICU Delirium | 66 Mean % delirious days | Standard Deviation 32 |
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
Time frame: ICU and hospital discharge
Population: Assessments can only be done on patients who were alive and were able to do participate in the assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NMES | Individual Muscle Strength Using Handheld Dynamometry: Tibialis Anterior, Gastrocnemius, and Quadriceps Muscle Strength | ICU Discharge-tibialis anterior | 19 pounds | Standard Deviation 9 |
| NMES | Individual Muscle Strength Using Handheld Dynamometry: Tibialis Anterior, Gastrocnemius, and Quadriceps Muscle Strength | Hospital Discharge-tibialis anterior | 19 pounds | Standard Deviation 16 |
| NMES | Individual Muscle Strength Using Handheld Dynamometry: Tibialis Anterior, Gastrocnemius, and Quadriceps Muscle Strength | ICU Discharge-gastrocnemius | 39 pounds | Standard Deviation 10 |
| NMES | Individual Muscle Strength Using Handheld Dynamometry: Tibialis Anterior, Gastrocnemius, and Quadriceps Muscle Strength | Hospital Discharge - gastrocnemius | 31 pounds | Standard Deviation 14 |
| NMES | Individual Muscle Strength Using Handheld Dynamometry: Tibialis Anterior, Gastrocnemius, and Quadriceps Muscle Strength | ICU Discharge - quadriceps | 33 pounds | Standard Deviation 14 |
| NMES | Individual Muscle Strength Using Handheld Dynamometry: Tibialis Anterior, Gastrocnemius, and Quadriceps Muscle Strength | Hospital discharge - quadriceps | 30 pounds | Standard Deviation 16 |
| Sham | Individual Muscle Strength Using Handheld Dynamometry: Tibialis Anterior, Gastrocnemius, and Quadriceps Muscle Strength | ICU Discharge - quadriceps | 28 pounds | Standard Deviation 14 |
| Sham | Individual Muscle Strength Using Handheld Dynamometry: Tibialis Anterior, Gastrocnemius, and Quadriceps Muscle Strength | ICU Discharge-tibialis anterior | 21 pounds | Standard Deviation 10 |
| Sham | Individual Muscle Strength Using Handheld Dynamometry: Tibialis Anterior, Gastrocnemius, and Quadriceps Muscle Strength | Hospital Discharge - gastrocnemius | 36 pounds | Standard Deviation 17 |
| Sham | Individual Muscle Strength Using Handheld Dynamometry: Tibialis Anterior, Gastrocnemius, and Quadriceps Muscle Strength | Hospital Discharge-tibialis anterior | 20 pounds | Standard Deviation 8 |
| Sham | Individual Muscle Strength Using Handheld Dynamometry: Tibialis Anterior, Gastrocnemius, and Quadriceps Muscle Strength | Hospital discharge - quadriceps | 33 pounds | Standard Deviation 14 |
| Sham | Individual Muscle Strength Using Handheld Dynamometry: Tibialis Anterior, Gastrocnemius, and Quadriceps Muscle Strength | ICU Discharge-gastrocnemius | 31 pounds | Standard Deviation 17 |
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)
Time frame: At hospital discharge
Population: Assessments can only be done on patients who were alive and were able to do participate in the assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NMES | Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps) | 27 MRC Score | Standard Deviation 23 |
| Sham | Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps) | 25 MRC Score | Standard Deviation 4 |
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).
Time frame: At ICU and Hospital discharge
Population: Assessments can only be done on patients who were alive and were able to do participate in the assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NMES | Mean Change in Subject's Lower Extremity Muscle Strength Composite Score From Baseline | Awakening to ICU Discharge | 5.3 MRC Score | Standard Deviation 5.9 |
| NMES | Mean Change in Subject's Lower Extremity Muscle Strength Composite Score From Baseline | ICU Discharge to Hospital Discharge | 5.7 MRC Score | Standard Deviation 5.1 |
| Sham | Mean Change in Subject's Lower Extremity Muscle Strength Composite Score From Baseline | ICU Discharge to Hospital Discharge | 1.8 MRC Score | Standard Deviation 2.7 |
| Sham | Mean Change in Subject's Lower Extremity Muscle Strength Composite Score From Baseline | Awakening to ICU Discharge | 0.8 MRC Score | Standard Deviation 3.8 |
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).
Time frame: ICU and hospital discharge
Population: Assessments can only be done on patients who were alive and were able to do participate in the assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NMES | Overall Body Strength | ICU Discharge | 49 MRC Composite Score | Standard Deviation 6 |
| NMES | Overall Body Strength | Hospital Discharge | 53 MRC Composite Score | Standard Deviation 4 |
| Sham | Overall Body Strength | ICU Discharge | 48 MRC Composite Score | Standard Deviation 8 |
| Sham | Overall Body Strength | Hospital Discharge | 50 MRC Composite Score | Standard Deviation 7 |
Secondary
Respiratory Muscle Strength
Measured using maximal inspiratory pressure (MIP) measurements that is then compared to predicted values for each participant (i.e., % predicted)
Time frame: ICU and hospital discharge
Population: Assessments can only be done on patients who were alive and were able to do participate in the assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NMES | Respiratory Muscle Strength | ICU Discharge | 61 % predicted | Standard Deviation 16 |
| NMES | Respiratory Muscle Strength | Hospital Discharge | 61 % predicted | Standard Deviation 16 |
| Sham | Respiratory Muscle Strength | ICU Discharge | 51 % predicted | Standard Deviation 37 |
| Sham | Respiratory Muscle Strength | Hospital Discharge | 51 % predicted | Standard Deviation 37 |
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.
Time frame: ICU and hospital discharge and change over time
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NMES | Subgroup Analysis | Whole body muscle strength score at hospital disch | 53 muscle strength score (higher is better) | Standard Deviation 4 |
| NMES | Subgroup Analysis | Lower extremity muscle strength at hospital discha | 28 muscle strength score (higher is better) | Standard Deviation 2 |
| NMES | Subgroup Analysis | Mean change in whole body strength (bsln to ICU) | 7.9 muscle strength score (higher is better) | Standard Deviation 8.8 |
| NMES | Subgroup Analysis | Lower extremity muscle strength at ICU discharge | 27 muscle strength score (higher is better) | Standard Deviation 2 |
| NMES | Subgroup Analysis | Mean change-whole body strength (bsln to hosp. dc) | 11.6 muscle strength score (higher is better) | Standard Deviation 8.9 |
| NMES | Subgroup Analysis | Whole body muscle strength score at ICU discharge | 48 muscle strength score (higher is better) | Standard Deviation 6 |
| Sham | Subgroup Analysis | Mean change-whole body strength (bsln to hosp. dc) | 5.8 muscle strength score (higher is better) | Standard Deviation 5.4 |
| Sham | Subgroup Analysis | Lower extremity muscle strength at ICU discharge | 25 muscle strength score (higher is better) | Standard Deviation 4 |
| Sham | Subgroup Analysis | Lower extremity muscle strength at hospital discha | 27 muscle strength score (higher is better) | Standard Deviation 3 |
| Sham | Subgroup Analysis | Whole body muscle strength score at hospital disch | 50 muscle strength score (higher is better) | Standard Deviation 7 |
| Sham | Subgroup Analysis | Mean change in whole body strength (bsln to ICU) | 3.4 muscle strength score (higher is better) | Standard Deviation 5.7 |
| Sham | Subgroup Analysis | Whole body muscle strength score at ICU discharge | 48 muscle strength score (higher is better) | Standard Deviation 8 |
Secondary
Total Hospital Charges
The total dollar amount of charges from hospital stay
Time frame: Hospital discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NMES | Total Hospital Charges | 163159 US dollars | Standard Deviation 117730 |
| Sham | Total Hospital Charges | 152968 US dollars | Standard Deviation 88683 |