The Efficacy of Neuromuscular Electrical Stimulation to Attenuate Muscle Loss

August 17, 2015 updated by: Dominique Hansen, Hasselt University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Hasselt, Belgium
        • Jessa Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: NMES
The 'NMES' arm will be treated with NMES.
Procedure: Neuromuscular Electrical Stimulation of m. quadriceps femoris
Neuromuscular Electrical Stimulation of m. quadriceps femoris by using a commercially available muscle stimulator
Other Names:
  • Electrical stimulation
SHAM_COMPARATOR: No NMES
The 'No NMES' arm of the experiment will be sham-treated with NMES. The device will be installed, but not used.
Procedure: Sham-treatment: no NMES
Sham comparator
Other Names:
  • No electrical stimulation; the leg will be sham-treated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 hours before and 12 hours after 10 days of twice-daily NMES

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in upper leg circumference
Time Frame: 3 hours before and 12 hours after 10 days of twice-daily NMES
Upper leg circumgerence will be measured; the change of upper leg circumference over time will be measured
3 hours before and 12 hours after 10 days of twice-daily NMES

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasselt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

January 18, 2012

First Submitted That Met QC Criteria

January 26, 2012

First Posted (ESTIMATE)

January 31, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 17, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMES2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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