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The Role of NEMS for Post ICU Rehabilitation

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Athens
Sponsor:
Information provided by (Responsible Party):
Serafim Nanas, University of Athens
ClinicalTrials.gov Identifier:
NCT01717833
First received: October 21, 2012
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Critical Illness
Procedure: NEMS
Procedure: Sham
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Neuromuscular Electrical Stimulation as a Tool for Post ICU Rehabilitation

Resource links provided by NLM:


Further study details as provided by University of Athens:

Primary Outcome Measures:
  • Muscle strength [ Time Frame: up to 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of hospital stay [ Time Frame: up to 2.5 years ] [ Designated as safety issue: No ]
  • Functional ability [ Time Frame: up to 2.5 years ] [ Designated as safety issue: No ]
    Functional ability will be assessed with the FIM score

  • Quality of life [ Time Frame: up to 2.5 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Muscle strength in patients with ICU acquired weakness (ICUAW) at ICU discharge [ Time Frame: up to 2.5 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 120
Study Start Date: November 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717833

Contacts
Contact: Serafim Nanas, Prof. 00306973036448 sernanas@gmail.com

Locations
Greece
First Critical Care Unit, Evaggelismos Hospital, School of Medicine Recruiting
Athens, Greece
Sub-Investigator: Vasiliki Gerovasili, MD         
Sub-Investigator: Irini Patsaki, MSc         
Sub-Investigator: George Sidiras, MSc         
Sub-Investigator: Anastasia Kotanidou, Assoc Prof         
Sub-Investigator: Christina Routsi, Assoc Prof         
Sub-Investigator: Georgios Strantzalis, Assoc Prof         
Sponsors and Collaborators
University of Athens
Investigators
Principal Investigator: Serafim Nanas, Professor University of Athens
  More Information

No publications provided

Responsible Party: Serafim Nanas, Professor, University of Athens
ClinicalTrials.gov Identifier: NCT01717833     History of Changes
Other Study ID Numbers: SN01032010
Study First Received: October 21, 2012
Last Updated: June 19, 2013
Health Authority: Greece: Ethics Committee

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

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014