The Role of NEMS for Post ICU Rehabilitation

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

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

Study Overview

• Status: Unknown
• Conditions: Critical Illness
• Intervention / Treatment: Procedure: NEMS; Procedure: Sham

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
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle strength in patients with ICU acquired weakness (ICUAW) at ICU discharge	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	up to 2.5 years

Collaborators and Investigators

• Sponsor: University of Athens
• Investigators: Principal Investigator: Serafim Nanas, Professor, University of Athens

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): December 1, 2014
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: October 21, 2012
• First Submitted That Met QC Criteria: October 28, 2012
• First Posted (Estimate): October 31, 2012

Study Record Updates

• Last Update Posted (Estimate): June 18, 2015
• Last Update Submitted That Met QC Criteria: June 17, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: handgrip; ICU acquired weakness; Critical illness polyneuromyopathy; post ICU rehabilitation; neuromuscular electrical rehabilitation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: SN01032010