The Efficacy of Neuromuscular Electrical Stimulation to Attenuate Muscle Loss

Hasselt University

Status: Completed

Conditions: Critical Illness; Neuromuscular Electrical Stimulation (NMES); Muscle Disuse

Treatments: Procedure: Neuromuscular Electrical Stimulation of m. quadriceps femoris; Procedure: Sham-treatment: no NMES

Study type: Interventional

Funder types: Other

Identifiers

NCT01521637

NMES2012

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

NMES

Experimental group

Description:

The 'NMES' arm will be treated with NMES.

Treatment:

Procedure: Neuromuscular Electrical Stimulation of m. quadriceps femoris

No NMES

Sham Comparator group

Description:

The 'No NMES' arm of the experiment will be sham-treated with NMES. The device will be installed, but not used.

Treatment:

Procedure: Sham-treatment: no NMES