Chronic Obstructive Pulmonary Disease, COPD
Conditions
Keywords
COPD, exercise training, pulmonary rehabilitation, antioxidant, muscle
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.
Interventions
DIETARY_SUPPLEMENTAntioxidant Supplementation associated to Comprehensive respiratory Rehabilitation Program
Vit E, Vit C, Selenomethionine, Zinc gluconate
Sponsors
5 Santé
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 78 Years
Healthy volunteers
No
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…)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| quadriceps endurance time.Time frame: at the start and the end of the study | 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
| Measure | Time frame | Description |
|---|---|---|
| muscle and /or serum oxidative stress level | 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 |
| Isometric maximal voluntary contraction of the quadriceps | 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. |
Countries
France
Outcome results
None listed