Clinical trial NCT01942889: Antioxidants and Pulmonary Rehabilitation in COPD Patients
Official title: Antioxidants Supplementation Associated With Pulmonary Rehabilitation is it Effective on Muscle Dysfunction and Signaling Pathways Involved in the Myopathy of COPD?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
COPD
Keywords: COPD
exercise training
pulmonary rehabilitation
antioxidant
muscle
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: 5 Santé
First posted: 2013-09-16
Enrollment: 64
Sex: ALL
Minimum age (years): 40
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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

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.

Eligibility criteria: 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...)

Primary outcomes:
measure: quadriceps endurance time.Time frame: at the start and the end of the study
timeFrame: up to day 37
Secondary outcomes:
measure: muscle and /or serum oxidative stress level
timeFrame: up to day 37
measure: Isometric maximal voluntary contraction of the quadriceps
timeFrame: up to day 37
Other outcomes:
Locations:
city: Lodève
country: France
facility: Clinique du souffle la vallonie
city: Montpellier
country: France
facility: University Hospital of Montpellier
Study officials:
References:
citation: Gouzi F, Maury J, Heraud N, Molinari N, Bertet H, Ayoub B, Blaquiere M, Bughin F, De Rigal P, Poulain M, Pincemail J, Cristol JP, Laoudj-Chenivesse D, Mercier J, Prefaut C, Pomies P, Hayot M. Additional Effects of Nutritional Antioxidant Supplementation on Peripheral Muscle during Pulmonary Rehabilitation in COPD Patients: A Randomized Controlled Trial. Oxid Med Cell Longev. 2019 Apr 17;2019:5496346. doi: 10.1155/2019/5496346. eCollection 2019.