The Role of NEMS for Post ICU Rehabilitation

Phase 2

• Conditions: Critical Illness
• Interventions: Procedure: NEMS; Procedure: Sham

• Registration Number: NCT01717833
• Lead Sponsor: 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

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 Timeline

• Study Start: 2010-11
• Study First Submitted: 2012-10-21
• Study First Submitted QC: 2012-10-28
• Study First Posted: 2012-10-31
• Primary Completion: 2014-12
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-17
• Last Update Posted: 2015-06-18
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NEMS group	NEMS	-
Sham group	Sham	-

Primary Outcome Measures

Name	Time	Method
Muscle strength	up to 2.5 years

Secondary Outcome Measures

Name	Time	Method
Functional ability	up to 2.5 years	Functional ability will be assessed with the FIM score
Quality of life	up to 2.5 years
Duration of hospital stay	up to 2.5 years

Trial Locations

Locations (1)

First Critical Care Unit, Evaggelismos Hospital, School of Medicine; 🇬🇷 Athens, Greece