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The Efficacy of Neuromuscular Electrical Stimulation to Attenuate Muscle Loss

Sponsor
Hasselt University (Other)
Overall Status
Completed
CT.gov ID
NCT01521637
Collaborator
(none)
15
Enrollment
1
Location
2
Arms

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Neuromuscular Electrical Stimulation of m. quadriceps femoris
  • Procedure: Sham-treatment: no NMES
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Efficacy of Neuromuscular Electrical Stimulation to Attenuate Skeletal Muscle Loss in ICU Patients
Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Apr 1, 2015

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in muscle fiber cross sectional area (CSA) [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 Outcome Measures

    1. Change in upper leg circumference [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jessa Hospital Hasselt Belgium

    Sponsors and Collaborators

    • Hasselt University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dominique Hansen, PhD, Hasselt University
    ClinicalTrials.gov Identifier:
    NCT01521637
    Other Study ID Numbers:
    • NMES2012
    First Posted:
    Jan 31, 2012
    Last Update Posted:
    Aug 19, 2015
    Last Verified:
    Aug 1, 2015
    Additional relevant MeSH terms:
    Critical Illness

    Study Results

    No Results Posted as of Aug 19, 2015