Effect of Electrostimulation in Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT01167283

Last Updated: 2010-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Electrostimulation

Neuromuscular electrical stimulation

Group Type ACTIVE_COMPARATOR

Electrostimulation

Intervention Type DEVICE

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

Sham stimulation

Sham stimulation

Group Type SHAM_COMPARATOR

Sham stimulation

Intervention Type DEVICE

Sham stimulation: 1 h; 5 times/week

Interventions

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Electrostimulation

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

Intervention Type DEVICE

Sham stimulation

Sham stimulation: 1 h; 5 times/week

Intervention Type DEVICE

Other Intervention Names

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NMES Sham

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Régional Universitaire Montpellier

OTHER

Sponsor Role collaborator

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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AEROBIE

Principal Investigators

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Olivier OJ Jonquet, PU-PH

Role: PRINCIPAL_INVESTIGATOR

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

Other Identifiers

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APARD

Identifier Type: -

Identifier Source: org_study_id

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