The Efficacy of Neuromuscular Electrical Stimulation to Attenuate Muscle Loss

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01521637
• Other study ID #: NMES2012
• Status: Completed
• Phase: N/A
• First received: January 18, 2012
• Last updated: August 17, 2015
• Start date: January 2012

Study information

• Verified date: August 2015
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Critical Illness
• Muscle Disuse
• Neuromuscular Electrical Stimulation (NMES)

Intervention

Procedure:
• Neuromuscular Electrical Stimulation of m. quadriceps femoris
Neuromuscular Electrical Stimulation of m. quadriceps femoris by using a commercially available muscle stimulator
• Sham-treatment: no NMES
Sham comparator

Locations

Country	Name	City	State
Belgium	Jessa Hospital	Hasselt

Sponsors (1)

Lead Sponsor	Collaborator
Hasselt University

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 hours before and 12 hours after 10 days of twice-daily NMES	No
Secondary	Change in upper leg circumference	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	No