NCT00442728

Brief Summary

The effect of neuromuscular electrical stimulation on muscle atrophy in sedated patients on intensive care was studied. The aim of this study was to explore if electrical stimulation could prevent muscle atrophy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2003

Shorter than 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2007

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 2, 2007

Completed
Last Updated

March 2, 2007

Status Verified

March 1, 2007

First QC Date

February 11, 2007

Last Update Submit

March 1, 2007

Conditions

Postoperative Coronary Artery Bypass Grafting (CABG)Chronic Obstructive Pulmonary Disease (COPD)Ventilatory Failure

Keywords

Functional electrical stimulationmuscular atrophyintensive care

Outcome Measures

Primary Outcomes (1)

  • Perimeter of the right and left thighs was measured in both groups every 3 days at 5 cm above the upp

Interventions

ELECTRICAL STIMULATIONDEVICE

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Patients were excluded from the study if they were still able to move their limb actively in spite of the sedation. Patients were also excluded if they had signs of recent ischemia or infarction for less then seven days. Patients with severe orthopaedic or vascular damage, i.e., fractures or oedema in the lower limbs were also excluded. Patients with an augmented risk for neuro electrical stimulation such as open wounds, hemodialysis or an arterial catheter at the stimulation area were also excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

REVAL

Hasselt, LIMBURG, 3500, Belgium

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveHypoventilationMuscular Atrophy

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory InsufficiencyRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative Techniques

Study Officials

  • RAf LJ Meesen, Phd

    PHL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 11, 2007

First Posted

March 2, 2007

Study Start

January 1, 2003

Study Completion

June 1, 2003

Last Updated

March 2, 2007

Record last verified: 2007-03

Locations

BE(1)