NCT01521637

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 31, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

3.2 years

First QC Date

January 18, 2012

Last Update Submit

August 17, 2015

Conditions

Muscle DisuseNeuromuscular Electrical Stimulation (NMES)Critical Illness

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Change in upper leg circumference

    3 hours before and 12 hours after 10 days of twice-daily NMES

Study Arms (2)

NMES

EXPERIMENTAL

The 'NMES' arm will be treated with NMES.

Procedure: Neuromuscular Electrical Stimulation of m. quadriceps femoris

No NMES

SHAM COMPARATOR

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

Procedure: Sham-treatment: no NMES

Interventions

Neuromuscular Electrical Stimulation of m. quadriceps femorisPROCEDURE

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

Also known as: Electrical stimulation
NMES
Sham-treatment: no NMESPROCEDURE

Sham comparator

Also known as: No electrical stimulation; the leg will be sham-treated
No NMES

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • Age between 18 and 80 years
  • Expected sedated time of \>24h

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jessa Hospital

Hasselt, Belgium

Location

MeSH Terms

Conditions

Critical Illness

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 18, 2012

First Posted

January 31, 2012

Study Start

January 1, 2012

Primary Completion

April 1, 2015

Last Updated

August 19, 2015

Record last verified: 2015-08

Locations

BE(1)