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Neuromuscular Electrical Stimulation in Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT00677690

Last Updated: 2011-11-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-01-31

Brief Summary

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The purpose of this study is to elucidate whether combination of usual pulmonary rehabilitation and neuromuscular electrical stimulation of quadriceps may improve exercise capacity in patients affected by chronic obstructive pulmonary disease (COPD).

Detailed Description

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Neuromuscular electrical stimulation (NMES) has been extensively used as technique to improve muscle function in different areas of rehabilitation, however it seems to be more appropriate in critical care situation, while its use in more able patients is of uncertain benefit. In other words, NMES seems to be particularly effective in severely deconditioned and bed ridden patients. We therefore carried out a randomised trial to compare the efficacy of combination of NMES and PR (NM+PR) with combination of sham stimulation and PR (SS+PR) in a large population of moderately impaired COPD patients. Primary outcome was evaluation of effect of NMES on quadriceps strength and on exercise capacity. Secondary outcome was evaluation of effect of NMES on symptoms (dyspnoea) and quality of life.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NM+PR

Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation (NM+PR)

Group Type ACTIVE_COMPARATOR

neuromuscular electrical stimulation (NMES)

Intervention Type OTHER

NMES was applied by means of a commercially available four channel electrostimulator which generated a symmetrical biphasic pulsed current. Each session lasted 30 minutes and was performed 5 days/week for 5 weeks.

SS+PR

Patients undergone to pulmonary rehabilitation

Group Type PLACEBO_COMPARATOR

Sham electrical stimulation

Intervention Type OTHER

Sham stimulation was performed with the same modality and time, but the stimulus was set up at 5 Hz.

Interventions

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neuromuscular electrical stimulation (NMES)

NMES was applied by means of a commercially available four channel electrostimulator which generated a symmetrical biphasic pulsed current. Each session lasted 30 minutes and was performed 5 days/week for 5 weeks.

Intervention Type OTHER

Sham electrical stimulation

Sham stimulation was performed with the same modality and time, but the stimulus was set up at 5 Hz.

Intervention Type OTHER

Other Intervention Names

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pulmonary rehabilitation pulmonary rehabilitation

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of COPD
* Must be able to walk

Exclusion Criteria

* Previous or current diagnosis of chronic respiratory failure
* A history of diseases other than COPD, in particular neurological disease
* Need for treatment with systemic steroids during the rehabilitation period
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Salvatore Maugeri

OTHER

Sponsor Role lead

Responsible Party

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Ercole Zanotti

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ercole zanotti, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Maugeri

Locations

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Fondazione Salvatore Maugeri

Montescano, Pavia, Italy

Site Status

Countries

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Italy

Other Identifiers

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05/2008

Identifier Type: -

Identifier Source: org_study_id