Mucoviscidosis and Inflammation, Variability through Exercise and Training: Maximal exercise test

Withdrawn

• Conditions: Cystic fibrosis; Mucoviscidosis; 10038686; 10010613

• Registration Number: NL-OMON32340
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 24

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 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary determinant: graded maximal exercise test.<br /><br><br /><br>The primary endpoint: exercise induced inflammatory response (EIIR). The EIIR<br /><br>is the difference between pre-exercise immune levels and post-exercise immune<br /><br>levels. </p><br>