Cystic fibrosis Mucoviscidosis
Conditions
Interventions
Niet van toepassing
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria which can be applied for the CF patients: - CF patients diagnosed by clinical features and a positive sweat chloride test with a homozygote *F508 mutation - CF patients in a clinically stable period: clinically stable means clinically stable for at least 4 weeks, since the exacerbation period. This means no use of (extra) oral or intravenous antibiotics for at least 4 weeks - CF patients with a doctor*s diagnosed acute exacerbation: this exacerbation needs treatment in the hospital with intravenous antibiotics. - Age: 12 to 18 years old - Sex: male and female;Inclusion criteria which can be applied for the healthy people: Healthy adults: - > 18 years old - Sex: male and female Healthy children: - Age: 12 to 18 years old - Sex: male and female
Exclusion criteria
Exclusion criteria: Exclusion criteria which can be applied for the CF patients: - Subjects with a physical exercise contraindication by a medical specialist - Subjects with a known contra-indicatory disease for exercise testing: acute or chronic cardiovascular disease, other pulmonary diseases than cystic fibrosis, acute renal disease, acute hepatitis, metabolic disorders, hemorrhagic diseases, orthostatic hypotension 90;91 - Subject with a known disease which can influences the immune system: acute or chronic inflammatory diseases, acute infection* - Subjects who used (inhalation) corticosteroids, and/ or immunosuppressive therapy the last month - Subjects who used extra antibiotics, on top of their prophylactic antibiotic treatment (regular treatment) within 4 weeks prior to the exercise testing.* - Subjects who have had a lung transplantation - Subjects who smoke * This exclusion criteria is not applied to CF patients with an exacerbation.;Exclusion criteria with regard to the healthy people: - Subjects with a physical exercise contraindication by a medical specialist - Subjects with a known contra-indicatory disease for exercise testing: acute or chronic cardiovascular disease, acute or chronic pulmonary disease, acute renal disease, acute hepatitis, metabolic disorders, hemorrhagic diseases, orthostatic hypotension 90;91 - Subject with a known disease which can influences the immune system: acute or chronic inflammatory diseases, acute infection* - Subjects who smoke - Subjects who used antibiotics, immunosuppressive therapy, and/ or (inhalation) corticosteroids within one month prior to the exercise testing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary determinant: graded maximal exercise test. The primary endpoint: exercise induced inflammatory response (EIIR). The EIIR is the difference between pre-exercise immune levels and post-exercise immune levels. | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secundary study parameters. Secundary endpoints: - Basal immune values (measurement t0). - Maximal exercise capacity: this will be determined by the following values: peak heart rate (HRpeak; beats/ min), RER, ventilation threshold (L/ min) according to the equivalent method100, peak oxygen uptake (VO2peak; L/ min)101, peak workload (Wpeak; watt)102, efficiency (ΔVO2/Δworkload; L/ min/ watt)103, maximal voluntary ventilation (VEpeak; L/ min), and oxygen saturation decrease (SaO2-decrease; %), whole blood lactate (mmol/ mL). - Exercise intolerance: when the participant has finished the maximal exercise before fully exhaustion. As mentioned in section 6.1.1. ad 1, this can be estimated by HRpeak and the RER. - Exercise induced dyspnoea perception and muscle fatigue perception: at the end of each maximal exercise test, participants are asked to score their sense of dyspnoea and muscle effort/ fatigue at peak exercise using Borg scales.104 scored with the Borg scale (see section F, appendix 2).104;105 - Terminating the maximal exercise test prior to reaching voluntary exhaustion. | — |
Countries
Netherlands
Outcome results
None listed