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NCT Number: NCT01942889

Antioxidants and Pulmonary Rehabilitation in COPD Patients

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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Key information

Conditions

Chronic Obstructive Pulmonary Disease COPD 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

40 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique du souffle la vallonie, Lodève, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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…)

Treatment and study plan

Antioxidant Supplementation associated to Comprehensive respiratory Rehabilitation Program

Dietary Supplement

Vit E, Vit C, Selenomethionine, Zinc gluconate

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • 5 Santé

Registry information

Official study title

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

Acronym: AREB-1

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 16, 2013
Registry last updated
Aug 16, 2018

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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