Antioxidants and Pulmonary Rehabilitation in COPD Patients (AREB-1)

August 14, 2018 updated by: University Hospital, Montpellier

Antioxidants Supplementation Associated With Pulmonary Rehabilitation is it Effective on Muscle Dysfunction and Signaling Pathways Involved in the Myopathy of COPD?

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

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lodève, France, 34700
        • Clinique du Souffle la Vallonie
      • Montpellier, France, 34295
        • University Hospital of Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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…)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Vit E, Vit C, Selenomethionine, Zinc gluconate
Active Comparator: 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).
Vit E, Vit C, Selenomethionine, Zinc gluconate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quadriceps endurance time.Time frame: at the start and the end of the study
Time Frame: up to day 37
sitting on a bench, starting from a 90° knee flexion of the dominant leg, the subjects should perform knee extensions (6 movements per minute) with a workload to 30% of the isometric maximal voluntary contraction until exhaustion. The duration of the test (in seconds) characterizes the quadriceps endurance.
up to day 37

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
muscle and /or serum oxidative stress level
Time Frame: up to day 37
Description: oxidative stress will be evaluated by measuring lipid peroxidation and oxidized proteins.GSH/ GSSG ratio and enzymatic/non enzymatic antioxidants
up to day 37
Isometric maximal voluntary contraction of the quadriceps
Time Frame: up to day 37
sitting on a bench with a force sensor connected to a data acquisition and analysis system signal, subjects should reproduce three trials spaced 1 minute, by an extension movement of the knee joint against a stationary load, maximum way, keeping the arms crossed over the chest and leaning against the back in order to limit the involvement of other muscles. The most elevated of the three tests repeatable value close to 10% characterizes the maximum strength of subjects.
up to day 37

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

August 14, 2013

First Submitted That Met QC Criteria

September 10, 2013

First Posted (Estimate)

September 16, 2013

Study Record Updates

Last Update Posted (Actual)

August 16, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

August 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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