The Effect of Neuromuscular Electrical Stimulation

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

on Muscle Wasting in Artificially Ventilated and Sedated Patients at the Intensive Care Unit: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00442728
• Other study ID #: REVAL300107
• Status: Completed
• Phase: N/A
• First received: February 11, 2007
• Last updated: March 1, 2007
• Start date: January 2003
• Est. completion date: June 2003

Study information

• Verified date: March 2007
• Source: Provinciale Hogeschool Limburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Hypoventilation
• Lung Diseases, Obstructive
• Postoperative Coronary Artery Bypass Grafting (CABG)
• Pulmonary Disease, Chronic Obstructive
• Ventilatory Failure

Intervention

Device:
• ELECTRICAL STIMULATION

Locations

Country	Name	City	State
Belgium	REVAL	Hasselt	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Provinciale Hogeschool Limburg	Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perimeter of the right and left thighs was measured in both groups every 3 days at 5 cm above the upp