The Effect of Neuromuscular Electrical Stimulation - Full Text View

Sponsors and Collaborators:	Provinciale Hogeschool Limburg KULeuven
Information provided by:	Provinciale Hogeschool Limburg
ClinicalTrials.gov Identifier:	NCT00442728

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

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	on Muscle Wasting in Artificially Ventilated and Sedated Patients at the Intensive Care Unit: a Pilot Study

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, LIMBURG
REVAL
HASSELT, LIMBURG, Belgium, 3500

Sponsors and Collaborators

Provinciale Hogeschool Limburg

KULeuven

Investigators

Principal Investigator:

RAf LJ Meesen, Phd

PHL

More Information

No publications provided

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

Keywords provided by Provinciale Hogeschool Limburg:

Functional electrical stimulation
muscular atrophy
intensive care

Study placed in the following topic categories:

Signs and Symptoms
Lung Diseases, Obstructive
Respiratory Insufficiency
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders

Hypoventilation
Signs and Symptoms, Respiratory
Atrophy
Muscular Atrophy
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Signs and Symptoms
Lung Diseases, Obstructive
Respiratory Insufficiency
Respiratory Tract Diseases
Lung Diseases

Respiration Disorders
Hypoventilation
Signs and Symptoms, Respiratory
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on May 07, 2009