The Efficacy of Neuromuscular Electrical Stimulation to Attenuate Muscle Loss

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Hasselt University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dominique Hansen, Hasselt University
ClinicalTrials.gov Identifier:
NCT01521637
First received: January 18, 2012
Last updated: February 28, 2012
Last verified: February 2012
  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: Open Label
Primary Purpose: Prevention
Official Title: The Efficacy of Neuromuscular Electrical Stimulation to Attenuate Skeletal Muscle Loss in ICU Patients

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
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

Ages Eligible for Study:   18 Years to 80 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01521637

Contacts
Contact: Marlou Dirks, MSc 0031433882215 marlou.dirks@maastrichtuniversity.nl
Contact: Dominique Hansen, PhD

Locations
Belgium
Jessa Hospital Recruiting
Hasselt, Belgium
Contact: Marlou Dirks         
Sponsors and Collaborators
Hasselt University
  More Information

No publications provided

Responsible Party: Dominique Hansen, PhD, Hasselt University
ClinicalTrials.gov Identifier: NCT01521637     History of Changes
Other Study ID Numbers: NMES2012
Study First Received: January 18, 2012
Last Updated: February 28, 2012
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2014