Text Size

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
History of Changes
  Purpose

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 Intervention
Postoperative Coronary Artery Bypass Grafting (CABG)
Chronic Obstructive Pulmonary Disease (COPD)
Ventilatory Failure
 Device: ELECTRICAL STIMULATION

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: on Muscle Wasting in Artificially Ventilated and Sedated Patients at the Intensive Care Unit: a Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Provinciale Hogeschool Limburg:

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

Estimated Enrollment: 21
Study Start Date: January 2003
Estimated Study Completion Date: June 2003
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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00442728

Locations
Belgium
REVAL
Hasselt, Limburg, Belgium, 3500
Sponsors and Collaborators
Provinciale Hogeschool Limburg
Katholieke Universiteit Leuven
Investigators
Principal Investigator: RAf LJ Meesen, Phd PHL
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00442728     History of Changes
Other Study ID Numbers: REVAL300107
Study First Received: February 11, 2007
Last Updated: March 1, 2007
Health Authority: Belgium: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013