Overview

This trial is active, not recruiting.

Condition critical illness
Treatments nems, sham
Phase phase 2
Sponsor University of Athens
Start date November 2010
End date December 2014
Trial size 120 participants
Trial identifier NCT01717833, SN01032010

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
nems Neuromuscular Electrical stimulation
NEMS sessions on both lower extremities (quadriceps and peroneus longus) simultaneously
(Sham Comparator)
sham Sham neuromuscular electrical stimulation
Sham sessions of neuromuscular electrical stimulation

Primary Outcomes

Measure
Muscle strength
time frame: up to 2.5 years

Secondary Outcomes

Measure
Duration of hospital stay
time frame: up to 2.5 years
Functional ability
time frame: up to 2.5 years
Quality of life
time frame: up to 2.5 years

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title The Role of Neuromuscular Electrical Stimulation as a Tool for Post ICU Rehabilitation
Principal investigator Serafim Nanas, Professor
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
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by University of Athens.