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

University Hospital Center (CHU)

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease; COPD

Treatments: Dietary Supplement: Antioxidant Supplementation associated to Comprehensive respiratory Rehabilitation Program

Study type: Interventional

Funder types: Other

Identifiers

NCT01942889

8710

Details and patient eligibility

About

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

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 40 to 78 years old

Volunteers: No Healthy Volunteers

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...)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

Antioxidant Supplementation

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Antioxidant Supplementation associated to Comprehensive respiratory Rehabilitation Program

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Antioxidant Supplementation associated to Comprehensive respiratory Rehabilitation Program