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Completed

NCT Number: NCT01167283

Effect of Electrostimulation in Chronic Obstructive Pulmonary Disease (COPD)

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrostimulation

Device

Electrostimulation: 35 Hz, 0.4 ms, 1 h; 5 times/week

Other names: NMES

Sham stimulation

Device

Sham stimulation: 1 h; 5 times/week

Other names: Sham

Primary outcomes

  1. Fiber-type distribution

    Time frame: 6 to 8 weeks

    Typology was evaluated by immunohistochemistry

Secondary outcomes

  1. Change in the strength of the quadriceps over the 6-week electrostimulation program

    Time frame: 6 to 8 weeks

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Collaborators

  • Centre Hospitalier Régional Universitaire Montpellier

Registry information

Official study title

Effect of Electromyostimulation in Severe Chronic Obstructive Pulmonary Disease

Acronym: ExaEMS2005

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Jul 22, 2010
Registry last updated
Aug 6, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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