The Efficacy of Neuromuscular Electrical Stimulation to Attenuate Muscle Loss

NCT ID: NCT01521637

Last Updated: 2015-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Muscle Disuse Neuromuscular Electrical Stimulation (NMES) Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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NMES

The 'NMES' arm will be treated with NMES.

Group Type EXPERIMENTAL

Neuromuscular Electrical Stimulation of m. quadriceps femoris

Intervention Type PROCEDURE

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

No NMES

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

Group Type SHAM_COMPARATOR

Sham-treatment: no NMES

Intervention Type PROCEDURE

Sham comparator

Interventions

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Neuromuscular Electrical Stimulation of m. quadriceps femoris

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

Intervention Type PROCEDURE

Sham-treatment: no NMES

Sham comparator

Intervention Type PROCEDURE

Other Intervention Names

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Electrical stimulation No electrical stimulation; the leg will be sham-treated

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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Dominique Hansen

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jessa Hospital

Hasselt, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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NMES2012

Identifier Type: -

Identifier Source: org_study_id

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