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

Muscle Weakness Clinical Trial

— NMES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00709124
• Other study ID #: NA_00017423
• Status: Completed
• Phase: N/A
• First received: July 1, 2008
• Last updated: January 12, 2018
• Start date: June 2008
• Est. completion date: April 2013

Study information

• Verified date: January 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intensive Care Unit
• Muscle Weakness
• Paresis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	At hospital discharge
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	ICU and hospital discharge
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).	ICU and hospital discharge
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)	ICU and hospital discharge
Secondary	Respiratory Muscle Strength	Measured using maximal inspiratory pressure (MIP) measurements that is then compared to predicted values for each participant (i.e., % predicted)	ICU and hospital discharge
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.	ICU and hospital discharge
Secondary	Duration of Mechanical Ventilation	The number of days the patient was on mechanical ventilation.	Until hospital discharge
Secondary	ICU and Hospital Length of Stay	The number of days that the patient was in the ICU and hospital, respectively.	ICU and Hospital discharge
Secondary	ICU and In-hospital Mortality	The number of patients who died in the ICU and those who died by hospital discharge.	ICU discharge and Hospital discharge
Secondary	Total Hospital Charges	The total dollar amount of charges from hospital stay	Hospital discharge
Secondary	Hospital Discharge Destination (e.g., Home, Rehab Facility)	Discharge location after hospital stay.	Hospital discharge
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)	At hospital discharge
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).	At ICU and Hospital discharge
Secondary	ICU Delirium	Proportion of ICU days the patient had delirium	During ICU stay - on days with study (NMES/Sham) session
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.	ICU and hospital discharge and change over time