The Role of NEMS for Post ICU Rehabilitation

National and Kapodistrian University of Athens

Status and phase: Unknown; Phase 2

Conditions: Critical Illness

Treatments: Procedure: NEMS; Procedure: Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT01717833

SN01032010

Details and patient eligibility

About

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

Full 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

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

NEMS group

Experimental group

Treatment:

Procedure: NEMS

Sham group

Sham Comparator group

Treatment:

Procedure: Sham