Respiratory
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Two groups will be included in this study. The following inclusion criteria will be applied: - A first group (Group G1) will be formed by COPD male subjects aged 20 to 65 years. The COPD obstruction must be classified mild, moderate or severe according to GOLD guidelines respectively - A second group (Group G2) will be formed by COPD male adults aged 20-65 years. the postbronchodilator FEV1 must be higher than 30% of predicted value. This group will serve as a control for the G1.
Exclusion criteria
Exclusion criteria: - contra-indications to 6MWT (signs of unstable angina or myocardial infarction within the previous month, resting heart rate = 120 bpm, systolic blood pressure = 180 mmHg, diastolic blood pressure = 100 mmHg) - Patients with limited physical activity and who cannot perform 6MWT (A known neuromuscular, orthopedic, rheumatologic or vascular disorders affecting the ability to exercise) - Patient who has been in further clinical trials in the previous year. - contra-indications to plethysmography. - deterioration of clinical status requiring hospitalization 3 months before the study - Asthmatic disease, Asthma-COPD Overlap - An upper airway abnormality. - History of chronic diseases (cardiac, renal, gastrointestinal, neurological; otorhinolaryngologic). - Acute upper respiratory tract infection during the three weeks preceding the evaluation - Acute exacerbation of COPD in the last 4 weeks. - Clinical manifestations of allergic diseases (urticaria, skin allergy, atopic dermatitis, eczema) - Inability to perform respiratory maneuvers properly
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the determination of antioxidant status (SOD, GPX, TAC, Homocysteine, uric acid) | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom scores (mMRC) Social disadvantage (CAT, HAD) Exercise tolerance (6MWT, Voorrips questionnaire) Lung function (FEV1, FEV1/FVC, FEV1%, TLC, FRC, RV, TLCO) Endothelial function Inflammatory indicators (CRP, IL6) HbA1c | — |
Countries
Tunisia
Contacts
University of Sousse