The Effect of Neuromuscular Electrical Stimulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00442728
Recruitment Status : Completed
First Posted : March 2, 2007
Last Update Posted : March 2, 2007
Katholieke Universiteit Leuven
Information provided by:
Provinciale Hogeschool Limburg

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.

Condition or disease Intervention/treatment Phase
Postoperative Coronary Artery Bypass Grafting (CABG) Chronic Obstructive Pulmonary Disease (COPD) Ventilatory Failure Device: ELECTRICAL STIMULATION Not Applicable

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  (Clinical Trial)
Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: on Muscle Wasting in Artificially Ventilated and Sedated Patients at the Intensive Care Unit: a Pilot Study
Study Start Date : January 2003
Study Completion Date : June 2003

Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00442728

Hasselt, Limburg, Belgium, 3500
Sponsors and Collaborators
Provinciale Hogeschool Limburg
Katholieke Universiteit Leuven
Principal Investigator: RAf LJ Meesen, Phd PHL Identifier: NCT00442728     History of Changes
Other Study ID Numbers: REVAL300107
First Posted: March 2, 2007    Key Record Dates
Last Update Posted: March 2, 2007
Last Verified: March 2007

Keywords provided by Provinciale Hogeschool Limburg:
Functional electrical stimulation
muscular atrophy
intensive care

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Respiratory Insufficiency
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms