COPD
Conditions
Interventions
The regular rehabilitation program in Ciro and network consists of a baseline assessment (duration: 3 days), rehabilitation program (duration: 5 days per week, 8 weeks) and an outcome assessment (dura
Sponsors
Ciro
Eligibility
Inclusion criteria
Inclusion criteria: - Objective diagnosis of COPD - Males - Age range from 40-59 year - No carcinogenic events for the last 5 years - Capability to read and understand the study protocol - N=10 lean body composition: BMI between 20 and 25 kg/m2 with a normal FFMI (> percentile 5 according to Franssen et al. ) and without metabolic syndrome). - N=10 with metabolic syndrome according to international criteria.
Exclusion criteria
Exclusion criteria: - Clinically important pulmonary disease other than COPD (e.g. but not limited to active lung infection, clinically significant bronchiectasis, pulmonary fibrosis, lung cancer, asthma as primary or main diagnosis) or other pulmonary disorder as judged by the Investigator. - An increase in complaints of the lungs defined by a physician as an exacerbation COPD within 4 weeks of the routine baseline assessment and between the period of routine baseline assessment and the first test day. - Participation in an investigational drug within 3 months prior to screening. - Loss of blood outside the limits of Sanquin (500 mL) within 3 months prior to screening or not willing to refrain from blood- or plasma donation during the study. - Average alcohol consumption > 21 units/week. - Unacceptable concomitant medication use at baseline, e.g., drugs known or likely to interact with the challenge drink or study assessments. o Use of non-steroidal anti-inflammatory drugs (NSAIDs) (i.e. ibuprofen, aspirin), statins, and beta-blockers is not allowed during the evening before and during the test days. Patients are eligible after approval by the doctor to stop the abovementioned medication the evening before and during the nutritional challenge test days. - Reported food allergy or sensitivity for one of the used ingredients of the Phenflex shake. - Not willing to accept information transfer which concerns participation in the study or information regarding health (e.g. laboratory results, findings at health and lifestyle questionnaire, physical examination or eventual adverse events) to and from their general practitioner. - Unintentional weight loss or gain > 5% body weight in the last month. - Clinically significant abnormalities, as judged by the investigator, in laboratory test results. In the case of uncertain or questionable results, tests performed during screening may be repeated once before determination of eligibility. This will be judged by the physician. - Inappropriate veins for cannula insertion. - Having a chronic auto-immune disease (such as arthritis). - Having a history or symptoms of any significant disease including (but not limited to), neurological, psychiatric, endocrine, gastrointestinal, hepatic, or renal disorder. - Unwillingness or inability to comply with the study protocol for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| What is the phenotypic flexibility of COPD patients before and after a comprehensive pulmonary rehabilitation program? | — |
Secondary
| Measure | Time frame |
|---|---|
| • To compare the phenotypic flexibility of COPD patients with the pre-obtained phenotypic flexibility of a healthy population and to diabetic type 2 patients; • To compare the phenotypic flexibility of COPD patients with lean body composition and metabolic syndrome before and after rehabilitation; • To explore associations between the phenotypic flexibility of COPD patients within the regular outcomes of pulmonary rehabilitation and the changes in these outcomes: o health status, assessed with the COPD Assessment Test o mood status, assessed with the Hospital Anxiety and Depression Scale o physical performance, assessed with the 6-minute walk distance and a constant work rate cycling test (75% of the pre-determined peak cycling output), quadriceps peak torque and endurance assessed on a computerized dynamometer o symptoms, assesses with the modified MRC dyspnoea scale (dyspnoea) and the fatigue domain of the Checklist Individual Strength (fatigue) o body composition, assessed with a whole-body and local DEXA scan • To explore associations between the change in phenotypic flexibility of COPD patients before and after rehabilitation and variables associated with phenotypic flexibility: o lifestyle measured with the lifestyle and health questionnaire o food intake measured by the Eetscore questionnaire o stress, assessed with hair cortisol levels. | — |
Contacts
Public ContactMiriam Groenen
Ciro
Outcome results
None listed