COPD, supplementation, antioxidants, rehabilitation COPD, supplementatie, antioxidatnen, revalidatie
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of COPD according to the American Thoracic Society (ATS) GOLD guidelines (FEV1 < 60% predicted and FEV1/FVC < 70% and < 10% predicted improvement in FEV1 after b2-agonist inhalation (14, 15)); 2. Both male and female, age-range from 40 to 75 years; 3. No respiratory tract infection or exacerbation of the disease for at least 4 weeks before the study; 4. Capable to provide informed consent; 5. Presence of other chronic diseases is allowed in case the clinical status is stable for at least 4 weeks before the study.
Exclusion criteria
Exclusion criteria: 1. Inability to perform the incremental cycle ergometer test; 2. Chronic use of antioxidants or vitamin supplements; 3. Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements; 4. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study; 5. Specific allergy or intolerance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To asses the effect of daily ingestion of a nutritional supplement enriched with antioxidants during 8 weeks pulmonary rehabilitation on resting and exercise-induced oxidative stress in COPD patients compared to an iso-caloric placebo. Oxidative stress will be measured by specific biomarkers in exhaled air, breath condensate, urine and venous blood. | — |
Secondary
| Measure | Time frame |
|---|---|
| To examine the effects of daily ingestion of a nutritional supplement enriched with antioxidants during pulmonary rehabilitation on respiratory and skeletal muscle strength and exercise capacity in COPD patients. | — |
Contacts
Research, Development and Education Centre for Integrated Rehabilitation of Organ Failure (CIRO)