The Effect of Neuromuscular Electrical Stimulation

This study has been completed.
Sponsor:
Collaborator:
Katholieke Universiteit Leuven
Information provided by:
Provinciale Hogeschool Limburg
ClinicalTrials.gov Identifier:
NCT00442728
First received: February 11, 2007
Last updated: March 1, 2007
Last verified: March 2007

February 11, 2007
March 1, 2007
January 2003
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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
Same as current
Complete list of historical versions of study NCT00442728 on ClinicalTrials.gov Archive Site
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The Effect of Neuromuscular Electrical Stimulation
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.

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.

Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Postoperative Coronary Artery Bypass Grafting (CABG)
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Ventilatory Failure
Device: ELECTRICAL STIMULATION
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
June 2003
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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.
Both
50 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00442728
REVAL300107
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Provinciale Hogeschool Limburg
Katholieke Universiteit Leuven
Principal Investigator: RAf LJ Meesen, Phd PHL
Provinciale Hogeschool Limburg
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP