The Role of NEMS for Post ICU Rehabilitation

NCT ID: NCT01717833

Last Updated: 2015-06-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2015-12-31

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

Conditions

Critical Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

NEMS group

Group Type: EXPERIMENTAL

NEMS

Intervention Type: PROCEDURE

NEMS sessions on both lower extremities (quadriceps and peroneus longus) simultaneously

Sham group

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: PROCEDURE

Sham sessions of neuromuscular electrical stimulation

Interventions

NEMS

NEMS sessions on both lower extremities (quadriceps and peroneus longus) simultaneously

Intervention Type: PROCEDURE

Sham

Sham sessions of neuromuscular electrical stimulation

Intervention Type: PROCEDURE

Other Intervention Names

Neuromuscular Electrical stimulation; Sham neuromuscular electrical stimulation

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Athens

OTHER

Sponsor Role: lead

Responsible Party

Serafim Nanas

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Serafim Nanas, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Athens

Locations

First Critical Care Unit, Evaggelismos Hospital, School of Medicine

Athens, , Greece

Countries

Greece

References

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.

Reference Type: DERIVED

PMID: 28364678 (View on PubMed)

Other Identifiers

SN01032010

Identifier Type: -

Identifier Source: org_study_id