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

NCT ID: NCT00709124

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2013-04-30

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.

Conditions

Intensive Care Unit; Muscle Weakness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

NMES

60 minute daily NMES sessions every day for the duration of subject's ICU stay.

Group Type: EXPERIMENTAL

Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA)

Intervention Type: 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.

Sham

60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: 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. Sham groups will NOT have voltage applied.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Other Intervention Names

CareStim Muscle Stimulation Device (Care Rehab; McLean, VA); CareStim Muscle Stimulation Device (Care Rehab; McLean, VA)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dale Needham, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25307979 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22421734 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20046132 (View on PubMed)

Other Identifiers

NA_00017423

Identifier Type: -

Identifier Source: org_study_id