The Role of NEMS for Post ICU Rehabilitation

Study Overview
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Brief Summary
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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
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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

Official Title
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The Role of Neuromuscular Electrical Stimulation as a Tool for Post ICU Rehabilitation

Conditions
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Critical Illness

Intervention / Treatment
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* Procedure: NEMS
* Procedure: Sham


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NEMS group<br> | Procedure: NEMS<br>* NEMS sessions on both lower extremities (quadriceps and peroneus longus) simultaneously<br>* Other names: Neuromuscular Electrical stimulation;|
| Sham Comparator: Sham group<br> | Procedure: Sham<br>* Sham sessions of neuromuscular electrical stimulation<br>* Other names: Sham neuromuscular electrical stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength |  | up to 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospital stay |  | up to 2.5 years | 
| Functional ability | Functional ability will be assessed with the FIM score | up to 2.5 years | 
| Quality of life |  | up to 2.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICU acquired weakness, Critical illness polyneuromyopathy, post ICU rehabilitation, neuromuscular electrical rehabilitation, handgrip