Back to resultsThe Efficacy of Neuromuscular Electrical Stimulation to Attenuate Muscle Loss
Primary Purpose
Muscle Disuse, Neuromuscular Electrical Stimulation (NMES), Critical Illness
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Neuromuscular Electrical Stimulation of m. quadriceps femoris
Sham-treatment: no NMES
Sponsored by
About this trial
This is an interventional prevention trial for Muscle Disuse
Eligibility 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
Sites / Locations
- Jessa Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
NMES
No NMES
Arm Description
The 'NMES' arm will be treated with NMES.
The 'No NMES' arm of the experiment will be sham-treated with NMES. The device will be installed, but not used.
Outcomes
Primary Outcome Measures
Change in muscle fiber cross sectional area (CSA)
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
Upper leg circumgerence will be measured; the change of upper leg circumference over time will be measured
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01521637
Brief Title
The Efficacy of Neuromuscular Electrical Stimulation to Attenuate Muscle Loss
Official Title
The Efficacy of Neuromuscular Electrical Stimulation to Attenuate Skeletal Muscle Loss in ICU Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Disuse, Neuromuscular Electrical Stimulation (NMES), Critical Illness
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NMES
Arm Type
Experimental
Arm Description
The 'NMES' arm will be treated with NMES.
Arm Title
No NMES
Arm Type
Sham Comparator
Arm Description
The 'No NMES' arm of the experiment will be sham-treated with NMES. The device will be installed, but not used.
Intervention Type
Procedure
Intervention Name(s)
Neuromuscular Electrical Stimulation of m. quadriceps femoris
Other Intervention Name(s)
Electrical stimulation
Intervention Description
Neuromuscular Electrical Stimulation of m. quadriceps femoris by using a commercially available muscle stimulator
Intervention Type
Procedure
Intervention Name(s)
Sham-treatment: no NMES
Other Intervention Name(s)
No electrical stimulation; the leg will be sham-treated
Intervention Description
Sham comparator
Primary Outcome Measure Information:
Title
Change in muscle fiber cross sectional area (CSA)
Description
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
Time Frame
3 hours before and 12 hours after 10 days of twice-daily NMES
Secondary Outcome Measure Information:
Title
Change in upper leg circumference
Description
Upper leg circumgerence will be measured; the change of upper leg circumference over time will be measured
Time Frame
3 hours before and 12 hours after 10 days of twice-daily NMES
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Jessa Hospital
City
Hasselt
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
The Efficacy of Neuromuscular Electrical Stimulation to Attenuate Muscle Loss
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