We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Efficacy of Neuromuscular Electrical Stimulation to Attenuate Muscle Loss

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01521637
First Posted: January 31, 2012
Last Update Posted: August 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dominique Hansen, Hasselt University
  Purpose
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 Intervention
Muscle Disuse Neuromuscular Electrical Stimulation (NMES) Critical Illness Procedure: Neuromuscular Electrical Stimulation of m. quadriceps femoris Procedure: Sham-treatment: no NMES

Study Type: Interventional
Study Design: 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

Further study details as provided by Dominique Hansen, Hasselt University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


Estimated Enrollment: 15
Study Start Date: January 2012
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: No electrical stimulation; the leg will be sham-treated

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521637


Locations
Belgium
Jessa Hospital
Hasselt, Belgium
Sponsors and Collaborators
Hasselt University
  More Information

Responsible Party: Dominique Hansen, PhD, Hasselt University
ClinicalTrials.gov Identifier: NCT01521637     History of Changes
Other Study ID Numbers: NMES2012
First Submitted: January 18, 2012
First Posted: January 31, 2012
Last Update Posted: August 19, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes