The Role of NEMS for Post ICU Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01717833
Recruitment Status : Unknown
Verified June 2015 by Serafim Nanas, University of Athens.
Recruitment status was:  Active, not recruiting
First Posted : October 31, 2012
Last Update Posted : June 18, 2015
Information provided by (Responsible Party):
Serafim Nanas, University of Athens

Brief Summary:
The purpose of this study is to investigate the role of NEMS as a rehabilitation tool for muscle weakness following critical illness. The investigators hypothesized that NEMS combined with exercise rehabilitation will have a beneficial role in restoration of muscle strength

Condition or disease Intervention/treatment Phase
Critical Illness Procedure: NEMS Procedure: Sham Phase 2

Detailed Description:

Survivors of critical illness are presented with significant physical impairment that is associated with reduced functional ability and health -related quality of life both in the short and long-term.

Neuromuscular electrical stimulation (NEMS) has been proposed as an alternative exercise modality in patients with severe chronic obstructive pulmonary disease and chronic heart failure, who cannot perform active exercise. NEMS has also been used as a preventive tool for intensive care unit (ICU) acquired weakness (ICUAW). Its role as a tool for post ICU rehabilitation has not been evaluated so far.

A randomized intervention study was designed to assess the efficacy of NEMS, as a rehabilitative tool for critical illness survivors. The first day that patients are discharged from the ICU after stratified randomization are assigned to the NEMS group or to the control group. In the NEMS group, NEMS will be applied to both lower extremities of the NEMS -group simultaneously (quadriceps femoris muscle and peroneus longus) on a daily basis, along with a personalized exercise program. NEMS sessions will continue until patient discharge from hospital. In the control group, sham NEMS will be applied along with standard care when it comes to physiotherapy. At hospital discharge patients of both groups of will receive a rehabilitation booklet. Patients on the NEMS group that have significant muscle weakness will have NEMS sessions at home for a period of 2 months. Patients are evaluated at 3 and 6 months after hospital discharge

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Neuromuscular Electrical Stimulation as a Tool for Post ICU Rehabilitation
Study Start Date : November 2010
Actual Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: NEMS group Procedure: NEMS
NEMS sessions on both lower extremities (quadriceps and peroneus longus) simultaneously
Other Name: Neuromuscular Electrical stimulation

Sham Comparator: Sham group Procedure: Sham
Sham sessions of neuromuscular electrical stimulation
Other Name: Sham neuromuscular electrical stimulation

Primary Outcome Measures :
  1. Muscle strength [ Time Frame: up to 2.5 years ]

Secondary Outcome Measures :
  1. Duration of hospital stay [ Time Frame: up to 2.5 years ]
  2. Functional ability [ Time Frame: up to 2.5 years ]
    Functional ability will be assessed with the FIM score

  3. Quality of life [ Time Frame: up to 2.5 years ]

Other Outcome Measures:
  1. Muscle strength in patients with ICU acquired weakness (ICUAW) at ICU discharge [ Time Frame: up to 2.5 years ]
    In the subgroup of patients diagnosed with ICUAW improvement in muscle strength will be assessed in patients of the NEMS group as compared to the sham-NEMS group

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients under mechanical ventilation for> 72hours during ICU stay
  • Patients able to perform simple commands (able to be evaluated by MRC scale)

Exclusion Criteria:

  • age < 18 > 85 years
  • pregnancy
  • pre-existing neuromuscular disease (e.g. Gravis)
  • fractures or skin lesions that do not allow the implementation of NEMS
  • presence of pacemaker or defibrillator
  • fractures of spine that so not allow mobilization
  • BMI > 35 kg/m2
  • terminal disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01717833

First Critical Care Unit, Evaggelismos Hospital, School of Medicine
Athens, Greece
Sponsors and Collaborators
University of Athens
Principal Investigator: Serafim Nanas, Professor University of Athens

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Serafim Nanas, Professor, University of Athens Identifier: NCT01717833     History of Changes
Other Study ID Numbers: SN01032010
First Posted: October 31, 2012    Key Record Dates
Last Update Posted: June 18, 2015
Last Verified: June 2015

Keywords provided by Serafim Nanas, University of Athens:
ICU acquired weakness
Critical illness polyneuromyopathy
post ICU rehabilitation
neuromuscular electrical rehabilitation

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes