Back to resultsThe Effect of Neuromuscular Electrical Stimulation
Primary Purpose
Postoperative Coronary Artery Bypass Grafting (CABG), Chronic Obstructive Pulmonary Disease (COPD), Ventilatory Failure
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
ELECTRICAL STIMULATION
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Coronary Artery Bypass Grafting (CABG) focused on measuring Functional electrical stimulation, muscular atrophy, intensive care
Eligibility Criteria
Inclusion Criteria:
- . Prior to inclusion in the study, an informed consent was given by the family of the patients which was approved by the local Ethics Committee of the Virga Jesse Hospital and was performed in accordance with the standards of the 1964 Declaration of Helsinki.
Exclusion Criteria:
- 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.
Sites / Locations
- REVAL
Outcomes
Primary Outcome Measures
Perimeter of the right and left thighs was measured in both groups every 3 days at 5 cm above the upp
Secondary Outcome Measures
Full Information
NCT ID
NCT00442728
First Posted
February 11, 2007
Last Updated
March 1, 2007
Sponsor
Provinciale Hogeschool Limburg
Collaborators
KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT00442728
Brief Title
The Effect of Neuromuscular Electrical Stimulation
Official Title
on Muscle Wasting in Artificially Ventilated and Sedated Patients at the Intensive Care Unit: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Provinciale Hogeschool Limburg
Collaborators
KU Leuven
4. Oversight
5. Study Description
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.
Detailed Description
Patients were included in the study one day after administration when prolonged sedation and ventilation were expected. They were divided into intervention (n=7) and control (n=14) groups. For the intervention group, an intermittent neuromuscular electrical stimulation was applied daily for 30 minutes on the right thigh whereas the left thigh was used as a control. Heart rate, respiration rate, systolic and diastolic blood pressure and oxygen saturation were monitored before, during and after the electrostimulation. Perimeter of the right and left thighs was measured in both groups every 3 days at 5 cm above the upper edge of the kneecap.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Coronary Artery Bypass Grafting (CABG), Chronic Obstructive Pulmonary Disease (COPD), Ventilatory Failure
Keywords
Functional electrical stimulation, muscular atrophy, intensive care
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
21 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
ELECTRICAL STIMULATION
Primary Outcome Measure Information:
Title
Perimeter of the right and left thighs was measured in both groups every 3 days at 5 cm above the upp
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
. Prior to inclusion in the study, an informed consent was given by the family of the patients which was approved by the local Ethics Committee of the Virga Jesse Hospital and was performed in accordance with the standards of the 1964 Declaration of Helsinki.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RAf LJ Meesen, Phd
Organizational Affiliation
PHL
Official's Role
Principal Investigator
Facility Information:
Facility Name
REVAL
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3500
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
The Effect of Neuromuscular Electrical Stimulation
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