The Role of NEMS for Post ICU Rehabilitation

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01717833
• Other study ID #: SN01032010
• Status: Active, not recruiting
• Phase: Phase 2
• First received: October 21, 2012
• Last updated: June 17, 2015
• Start date: November 2010
• Est. completion date: December 2015

Study information

• Verified date: June 2015
• Source: University of Athens
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness

Intervention

Procedure:
• NEMS
NEMS sessions on both lower extremities (quadriceps and peroneus longus) simultaneously
• Sham
Sham sessions of neuromuscular electrical stimulation

Locations

Country	Name	City	State
Greece	First Critical Care Unit, Evaggelismos Hospital, School of Medicine	Athens

Sponsors (1)

Lead Sponsor	Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	Muscle strength		up to 2.5 years	No
Secondary	Duration of hospital stay		up to 2.5 years	No
Secondary	Functional ability	Functional ability will be assessed with the FIM score	up to 2.5 years	No
Secondary	Quality of life		up to 2.5 years	No