Coordinated diet and exercise program for adults with cystic fibrosis
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Tours Academic / other |
| Locations | 4 sites (Angers and 3 other locations) |
| Trial ID | NCT06457451 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are pregnant, have severe physical limitations, or cannot comply with the program requirements may not benefit from this study.
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 performed: Other studies have shown promising results with similar dietary and physical activity interventions in cystic fibrosis, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Angers and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.