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The Role of NEMS for Post ICU Rehabilitation

Primary Purpose

Critical Illness

Status
Unknown status
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
NEMS
Sham
Sponsored by
University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring ICU acquired weakness, Critical illness polyneuromyopathy, post ICU rehabilitation, neuromuscular electrical rehabilitation, handgrip

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • First Critical Care Unit, Evaggelismos Hospital, School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

NEMS group

Sham group

Arm Description

Outcomes

Primary Outcome Measures

Muscle strength

Secondary Outcome Measures

Duration of hospital stay
Functional ability
Functional ability will be assessed with the FIM score
Quality of life

Full Information

First Posted
October 21, 2012
Last Updated
June 17, 2015
Sponsor
University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT01717833
Brief Title
The Role of NEMS for Post ICU Rehabilitation
Official Title
The Role of Neuromuscular Electrical Stimulation as a Tool for Post ICU Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Athens

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
ICU acquired weakness, Critical illness polyneuromyopathy, post ICU rehabilitation, neuromuscular electrical rehabilitation, handgrip

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NEMS group
Arm Type
Experimental
Arm Title
Sham group
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
NEMS
Other Intervention Name(s)
Neuromuscular Electrical stimulation
Intervention Description
NEMS sessions on both lower extremities (quadriceps and peroneus longus) simultaneously
Intervention Type
Procedure
Intervention Name(s)
Sham
Other Intervention Name(s)
Sham neuromuscular electrical stimulation
Intervention Description
Sham sessions of neuromuscular electrical stimulation
Primary Outcome Measure Information:
Title
Muscle strength
Time Frame
up to 2.5 years
Secondary Outcome Measure Information:
Title
Duration of hospital stay
Time Frame
up to 2.5 years
Title
Functional ability
Description
Functional ability will be assessed with the FIM score
Time Frame
up to 2.5 years
Title
Quality of life
Time Frame
up to 2.5 years
Other Pre-specified Outcome Measures:
Title
Muscle strength in patients with ICU acquired weakness (ICUAW) at ICU discharge
Description
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
Time Frame
up to 2.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serafim Nanas, Professor
Organizational Affiliation
University of Athens
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Critical Care Unit, Evaggelismos Hospital, School of Medicine
City
Athens
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
28364678
Citation
Patsaki I, Gerovasili V, Sidiras G, Karatzanos E, Mitsiou G, Papadopoulos E, Christakou A, Routsi C, Kotanidou A, Nanas S. Effect of neuromuscular stimulation and individualized rehabilitation on muscle strength in Intensive Care Unit survivors: A randomized trial. J Crit Care. 2017 Aug;40:76-82. doi: 10.1016/j.jcrc.2017.03.014. Epub 2017 Mar 22.
Results Reference
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The Role of NEMS for Post ICU Rehabilitation

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