Coordinated diet and exercise program for adults with cystic fibrosis
Official title: Impact d'un Programme coordonné diététique-activité Physique adaptée Sur le Pourcentage de Masse Maigre d'Adultes Atteints de Mucoviscidose traités Par Elexacaftor-Tezacaftor-Ivacaftor : Essai contrôlé randomisé Multicentrique
Run by University Hospital, Tours · NCT06457451 · Data updated 2026-11-12
This study is testing whether a special diet and exercise program can help adults with cystic fibrosis gain muscle and improve their health while they are on a specific medication.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University Hospital, Tours Academic / other |
| Locations | 4 sites (Angers and 3 other locations) |
| Status | Recruiting |
| Started | November 25, 2024 |
| Main results expected | November 2027 |
| Study ends | November 2027 |
| Registry record updated | December 1, 2025 |
| Trial ID | NCT06457451 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and over with cystic fibrosis who have been on Elexacaftor-Tezacaftor-Ivacaftor treatment for at least six months.
✕Probably not a fit
Patients who are pregnant, have severe physical limitations, or cannot comply with the program requirements may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the impact of a coordinated dietetic-adapted physical activity program on increasing lean body mass in adults with cystic fibrosis who are being treated with Elexacaftor-Tezacaftor-Ivacaftor. The program aims to address malnutrition and improve muscle function through tailored dietary adjustments and physical activity. Participants will be monitored for changes in body composition and respiratory function over the course of the intervention. The study is multicenter and randomized, ensuring a diverse participant pool and robust data collection.
Why it matters
Potential benefit: If successful, this program could enhance muscle mass and overall health in adults with cystic fibrosis, leading to improved respiratory function and quality of life.
How similar studies have gone: Other studies have shown promising results with similar dietary and physical activity interventions in cystic fibrosis, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject aged 18 or over * Suffering from cystic fibrosis * Treated with Elexacaftor-Tezacaftor-Ivacaftor for at least 6 months * Affiliated to a social security scheme * with a signed Informed Consent form. Exclusion Criteria: * Pregnant and breast-feeding women * Subject under legal protection, guardianship or curatorship * Subject whose physical activity is not medically authorised or whose physical and motor capacities do not allow them to take part in physical activity. * Subject who is unable to comply with the requirements of the DIAPASOM program * Difficulty in understanding the self-questionnaires * Wearing a pacemaker or metal prosthesis * Fluid retention
Where it's running
-
Cystic Fibrosis Resource and Competence Centre, University Hospital, Angers
Angers, France Recruiting -
Cystic Fibrosis Resource and Competence Centre, Fondation Ildys, Roscoff
Roscoff, France Recruiting -
Cystic Fibrosis Resource and Competence Centre, University Hospital, Tours
Tours, France Recruiting -
Cystic Fibrosis Resource and Competence Centre, Hospital, Tours
Vannes, France Recruiting
Study contacts
- Principal investigator: Julie MANKIKIAN, MD — University Hospital, Tours
- Study coordinator: Amelie GIBORY
- Email: a.gibory@chu-tours.fr
- Phone: 0247474747
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Inhaled CFTR mRNA for cystic fibrosis in Chinese patients aged 12 and older
This trial tests inhaled BMD003, a CFTR mRNA therapy, to see if it's safe and shows early signs of benefit in Chinese people 12 years and up with cystic fibrosis.
-
VX-272 dose escalation in healthy adults
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-
Prevalence of smoking, passive smoke exposure, and vaping among adults with cystic fibrosis
This project will see how common smoking, exposure to secondhand smoke, and vaping are among adults with cystic fibrosis followed at the Strasbourg Adult CF Center.
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The trial will test increasing doses of VX-581 in healthy adults to see if it is safe and to measure how the body absorbs and clears the drug.
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PALMIRE cohort: phenotyping inflammatory lung diseases to enable personalized care
This project will collect clinical, imaging, and biological data from adults with asthma, COPD, bronchiectasis, cystic fibrosis, primary ciliary dyskinesia, or interstitial lung disease to try to identify disease subtypes and markers that could guide more personalized care.
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Collecting sputum samples at home for cystic fibrosis patients
This study is testing if collecting sputum samples at home can help people with cystic fibrosis better identify lung infections compared to traditional methods done at the clinic.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.