Effect of Electrostimulation in Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease Clinical Trial

— ExaEMS2005  

Official title:

Effect of Electromyostimulation in Severe Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01167283
• Other study ID #: APARD
• Status: Completed
• Phase: N/A
• First received: July 13, 2010
• Last updated: August 5, 2010
• Start date: July 2006
• Est. completion date: April 2010

Study information

• Verified date: July 2010
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

This study was designed to test the following hypothesis:

To investigate whether COPD muscles can respond to stimuli in terms of changes in fiber-type distribution.

Description:

Background: Muscle dysfunction is a major problem in chronic obstructive pulmonary disease (COPD). It is characterized by muscle fiber-type redistribution and oxidative stress. Classical training does not improve these features.

Objectives: To investigate whether electrostimulation program following exacerbation can modify muscle structure and function in COPD patients.

Method: We propose to conduct a controlled and randomized clinical trial comparing the efficacy of muscle electrostimulation training of the lower limbs to sham training in 15 patients with COPD. Patients are included in either 6 weeks of electrostimulation training (active treatment group) or 6 weeks of sham electrostimulation. Primary outcomes were changes in muscle structure, muscle oxidative stress and their relationship with quadriceps force and exercise tolerance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• COPD patients during or after exacerbation

Exclusion Criteria:

• Comorbidities that could limit exercise training

• Obesity (body mass index [BMI] > 30 kg/m²)

• Neuromuscular disease

• Pacemaker implantation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Electrostimulation
Electrostimulation: 35 Hz, 0.4 ms, 1 h; 5 times/week
• Sham stimulation
Sham stimulation: 1 h; 5 times/week

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France	Centre Hospitalier Régional Universitaire Montpellier

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fiber-type distribution	Typology was evaluated by immunohistochemistry	6 to 8 weeks	No
Secondary	Change in the strength of the quadriceps over the 6-week electrostimulation program		6 to 8 weeks	No