Antioxidants and Pulmonary Rehabilitation in COPD Patients

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

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-12-31

Brief Summary

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On the basis of published data and investigators results indicating that systemic redox in balance may contribute to the peripheral muscle dysfunction in COPD patients, the investigators propose a study testing the effects of antioxidants and exercise training in COPD patients. The results may have major implication in the improvement of pulmonary rehabilitation benefits

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Detailed Description

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COPD will constitute the third cause of mortality in 2012. This chronic respiratory disease is characterized by peripheral dysfunction of skeletal muscle which is associated with major clinical outcomes (prognostics, symptoms, and health related quality of life). Muscle and systemic oxidative stress has been incriminated in this peripheral muscle dysfunction.Exercise training constitute the main validated therapeutic intervention leading to significant muscle function and clinical improvement.Our preliminary results have shown that COPD patients experiment dietary and enzymatic antioxidants defects.Yet, generic antioxidant supplementation has not shown significant muscle function improvement.Therefore, we aim to test the effects of an antioxidant supplementation targeted on the antioxidant defects associated with exercise training on the peripheral muscle function, exercise tolerance and health quality of life in COPD patients.At the cellular level, this muscle dysfunction is related with a fiber atrophy and a metabolic switch (reduce proportion of oxidative fiber).This study will compare the effects of an antioxidant supplementation on the peripheral muscle function and skeletal muscle cellular properties in association with exercise training during a pulmonary rehabilitation course.Volunteers will be randomised in 2 groups: - 1 group treated with the antioxidant supplementation ( 28 days)- 1 group treated with the placeboIntervention will be allocated by chance and a double blind manner. Antioxidant supplementation will associate vitamins and trace elements that won't exceed the maximal nutritional dose recommended.

Conditions

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Chronic Obstructive Pulmonary Disease COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Antioxidant Supplementation

Vitamin antioxidant and trace elements combination that won't exceed the maximal nutritional dose recommended in France (Vit E, vit C, Selenomethionine, Zinc gluconate).

Group Type ACTIVE_COMPARATOR

Antioxidant Supplementation associated to Comprehensive respiratory Rehabilitation Program

Intervention Type DIETARY_SUPPLEMENT

Vit E, Vit C, Selenomethionine, Zinc gluconate

Placebo

Group Type PLACEBO_COMPARATOR

Antioxidant Supplementation associated to Comprehensive respiratory Rehabilitation Program

Intervention Type DIETARY_SUPPLEMENT

Vit E, Vit C, Selenomethionine, Zinc gluconate

Interventions

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Antioxidant Supplementation associated to Comprehensive respiratory Rehabilitation Program

Vit E, Vit C, Selenomethionine, Zinc gluconate

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* COPD patients, 40 years to 78 years, last exacerbation dating at least 4 weeks

Exclusion Criteria

* unstabilized primary pathologies (cardiovascular, renal, metabolic, psychiatric)
* nutritional supplementation in the 4 weeks preceding the study (antioxidant, vitamins…)

Minimum Eligible Age

40 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No