Clinical trial NCT00709124: Use of Neuromuscular Electrostimulation (NMES) for Treatment or Prevention of ICU-Associated Weakness
Official title: Use of Neuromuscular Electrostimulation (NMES) for Treatment or Prevention of ICU-Associated Weakness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intensive Care Unit
Muscle Weakness
Keywords: Respiration, Artificial
Critical Illness
Intensive Care Units
Electric Stimulation Therapy
Muscle Weakness
Paresis
Mechanically
Ventilated
Patients
Admitted
Medical
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2008-07-03
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: At hospital discharge
Secondary outcomes:
measure: Individual Muscle Strength Using Handheld Dynamometry: Tibialis Anterior, Gastrocnemius, and Quadriceps Muscle Strength
timeFrame: ICU and hospital discharge
measure: Overall Body Strength
timeFrame: ICU and hospital discharge
measure: Hand Grip Strength
timeFrame: ICU and hospital discharge
measure: Respiratory Muscle Strength
timeFrame: ICU and hospital discharge
measure: Functional Status Measured Using Functional Status Score for the Intensive Care Unit
timeFrame: ICU and hospital discharge
measure: Duration of Mechanical Ventilation
timeFrame: Until hospital discharge
measure: ICU and Hospital Length of Stay
timeFrame: ICU and Hospital discharge
measure: ICU and In-hospital Mortality
timeFrame: ICU discharge and Hospital discharge
measure: Total Hospital Charges
timeFrame: Hospital discharge
measure: Hospital Discharge Destination (e.g., Home, Rehab Facility)
timeFrame: Hospital discharge
measure: Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps)
timeFrame: At hospital discharge
measure: Mean Change in Subject's Lower Extremity Muscle Strength Composite Score From Baseline
timeFrame: At ICU and Hospital discharge
measure: ICU Delirium
timeFrame: During ICU stay - on days with study (NMES/Sham) session
measure: Subgroup Analysis
timeFrame: ICU and hospital discharge and change over time
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Dale Needham, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Kho ME, Truong AD, Brower RG, Palmer JB, Fan E, Zanni JM, Ciesla ND, Feldman DR, Korupolu R, Needham DM. Neuromuscular electrical stimulation for intensive care unit-acquired weakness: protocol and methodological implications for a randomized, sham-controlled, phase II trial. Phys Ther. 2012 Dec;92(12):1564-79. doi: 10.2522/ptj.20110437. Epub 2012 Mar 15.
citation: Needham DM, Truong AD, Fan E. Technology to enhance physical rehabilitation of critically ill patients. Crit Care Med. 2009 Oct;37(10 Suppl):S436-41. doi: 10.1097/CCM.0b013e3181b6fa29.