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Completed

NCT Number: NCT01521637

The Efficacy of Neuromuscular Electrical Stimulation to Attenuate Muscle Loss

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.

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Key information

Conditions

Muscle Disuse Critical Illness Disease Attributes Neuromuscular Electrical Stimulation (NMES) Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Jessa Hospital

Hasselt, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuromuscular Electrical Stimulation of m. quadriceps femoris

Procedure

Neuromuscular Electrical Stimulation of m. quadriceps femoris by using a commercially available muscle stimulator

Other names: Electrical stimulation

Sham-treatment: no NMES

Procedure

Sham comparator

Other names: No electrical stimulation; the leg will be sham-treated

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
First posted
Jan 31, 2012
Registry last updated
Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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