Mucoviscidosis and Inflammation, Variability through Exercise and Training: physical exercise program

Completed

• Conditions: Cystic Fibrosis; Mucoviscidosis; 10038686; 10010613

• Registration Number: NL-OMON35260
• 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: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

Patiënten met CF:
- CF patients diagnosed by clinical features and a positive sweat chloride test with a homozygote *F508 mutation
- Sex: male and female
- Age: 12 to 18 years old
- Participants have to be clinically stable for at least 4 weeks, which means no use of extra oral or intravenous antibiotics for at least four weeks.;Healthy controls:
- Age; 12 - 18 years old
- Sex: male and female

Exclusion Criteria

Patients with cystic fibrosis and healthy controls:
- Subjects with a physical exercise contraindication by a medical specialist
- Subjects who use (inhalation) corticosteroids, and/ or immunosuppressive therapy
- Subjects who have had a lung transplantation;Healthy controls:
- Subjects who have allergies, asthma or auto-immune diseases.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Determinant:<br /><br>Physical exercise program based on the Canadian Air Force program with a<br /><br>duration of 12 weeks.<br /><br><br /><br>Endpoint:<br /><br>Differences in the EIIR: difference between the EIIR before physical exercise<br /><br>training and the EIIR after physical exercise training. Different markers of<br /><br>the immune system will be collected from an i.v. access at two different time<br /><br>points.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>- Difference between basal immune values of patients with CF and healthy<br /><br>controls<br /><br>- Difference between basal immune values, pre-training versus post-training<br /><br>- Difference in pulmonary function<br /><br>- Difference in maximal exercise capacity<br /><br>- Difference in the exercise induced dyspnoea perception and muscle fatigue<br /><br>perception<br /><br>- Difference in quality of life<br /><br>- Difference in anthropometric values<br /><br>- Pulmonary exacerbation<br /><br>- Terminating the maximal exercise test prior to reaching voluntary exhaustion</p><br>