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Clinical Trials/NCT01521637
NCT01521637
Completed
Not Applicable

The Efficacy of Neuromuscular Electrical Stimulation to Attenuate Skeletal Muscle Loss in ICU Patients

Hasselt University1 site in 1 country15 target enrollmentJanuary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Muscle Disuse
Sponsor
Hasselt University
Enrollment
15
Locations
1
Primary Endpoint
Change in muscle fiber cross sectional area (CSA)
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Subjects who are hospitalized in the ICU will be included after 24 hours of intubation during their ICU stay. Twice-daily Neuromuscular Electrical Stimulation (NMES) will be performed on one leg for 2x40 min per day to assess muscle fiber size. The investigators hypothesize an attenuated loss in muscle fiber size.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
April 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Sponsor
Hasselt University
Responsible Party
Principal Investigator
Principal Investigator

Dominique Hansen

PhD

Hasselt University

Eligibility Criteria

Inclusion Criteria

  • Age between 18 and 80 years
  • Expected sedated time of \>24h

Exclusion Criteria

  • Spinal Cord Injury
  • Arterial operaties on the legs
  • Local wounds that prohibit NMES
  • Chronic use of corticosteroids
  • Intake of certain antithrombotic drugs
  • Presence of implantable cardioverter defibrillator and/or pacemaker

Outcomes

Primary Outcomes

Change in muscle fiber cross sectional area (CSA)

Time Frame: 3 hours before and 12 hours after 10 days of twice-daily NMES

Muscle fiber cross sectional area (in um2) for type I and II fibers will be analyzed by using immunohistochemistry; the change of muscle fiber CSA over time will be measured

Secondary Outcomes

  • Change in upper leg circumference(3 hours before and 12 hours after 10 days of twice-daily NMES)

Study Sites (1)

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