N/A
N=34
Use of Neuromuscular Electrostimulation (NMES) for Treatment or Prevention of ICU-Associated Weakness
Intensive Care Unit · Muscle Weakness
Bottom Line
View on ClinicalTrials.gov: NCT00709124 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: 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 — 28; 27 units (range 0-30; higher is better)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA) (Device); Sham (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
28; 27 | — |
| SECONDARY Individual Muscle Strength Using Handheld Dynamometry: Tibialis Anterior, Gastrocnemius, and Quadriceps Muscle Strength |
19; 21; 19; 20; 39; 31 | — |
| SECONDARY Overall Body Strength |
49; 48; 53; 50 | — |
| SECONDARY Hand Grip Strength |
34; 41; 46; 40 | — |
| SECONDARY Respiratory Muscle Strength |
61; 51; 61; 51 | — |
| SECONDARY Functional Status Measured Using Functional Status Score for the Intensive Care Unit |
20; 19; 30; 26 | — |
| SECONDARY Duration of Mechanical Ventilation |
20; 16 | — |
| SECONDARY ICU and Hospital Length of Stay |
22; 20; 36; 35 | — |
| SECONDARY ICU and In-hospital Mortality |
3; 1; 3; 3 | — |
| SECONDARY Total Hospital Charges |
163159; 152968 | — |
| SECONDARY Hospital Discharge Destination (e.g., Home, Rehab Facility) |
5; 8; 4; 6; 4; 1 | — |
| SECONDARY Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps) |
27; 25 | — |
| SECONDARY Mean Change in Subject's Lower Extremity Muscle Strength Composite Score From Baseline |
5.3; 0.8; 5.7; 1.8 | — |
| SECONDARY ICU Delirium |
67; 66 | — |
| SECONDARY Subgroup Analysis |
27; 25; 28; 27; 48; 48 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00709124). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.