Clinical Trials Directory

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UnknownNCT01717833

The Role of NEMS for Post ICU Rehabilitation

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

Status
Unknown
Phase
Phase 2
Study type
Interventional
Enrollment
120 (estimated)
Sponsor
University of Athens · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDURENEMSNEMS sessions on both lower extremities (quadriceps and peroneus longus) simultaneously
PROCEDUREShamSham sessions of neuromuscular electrical stimulation

Timeline

Start date
2010-11-01
Primary completion
2014-12-01
Completion
2015-12-01
First posted
2012-10-31
Last updated
2015-06-18

Locations

1 site across 1 country: Greece

Source: ClinicalTrials.gov record NCT01717833. Inclusion in this directory is not an endorsement.