Reduction of OXidative stress in Chronic Obstructive Pulmonary Disease by Exercise and Nutritio
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)RespiratoryPulmonary diseases
- Registration Number
- ISRCTN62421408
- Lead Sponsor
- umico Research B.V. (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
1. Diagnosis of COPD according to the American Thoracic Society (ATS) Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (Forced Expiratory Volume in one second [FEV1] less than 60% predicted and FEV1/Forced Vital Capacity [FVC] less than 70% and less than 10% predicted improvement in FEV1 after b2-agonist inhalation
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 four 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 four weeks before the study
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the effect of daily ingestion of a nutritional supplement enriched with antioxidants during eight 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, measured at the start of the rehabilitation and after eight weeks.
- Secondary Outcome Measures
Name Time Method 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, measured at the start of the rehabilitation and after eight weeks.