- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00442728
The Effect of Neuromuscular Electrical Stimulation
March 1, 2007 updated by: Provinciale Hogeschool Limburg
on Muscle Wasting in Artificially Ventilated and Sedated Patients at the Intensive Care Unit: a Pilot Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Limburg
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Hasselt, Limburg, Belgium, 3500
- REVAL
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Perimeter of the right and left thighs was measured in both groups every 3 days at 5 cm above the upp
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: RAf LJ Meesen, Phd, PHL
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2003
Study Completion
June 1, 2003
Study Registration Dates
First Submitted
February 11, 2007
First Submitted That Met QC Criteria
March 1, 2007
First Posted (Estimate)
March 2, 2007
Study Record Updates
Last Update Posted (Estimate)
March 2, 2007
Last Update Submitted That Met QC Criteria
March 1, 2007
Last Verified
March 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REVAL300107
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.