Clinical trial Recruiting at 4 sites Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorUniversity Hospital, Tours
Academic / other
Locations4 sites (Angers and 3 other locations)
StatusRecruiting
StartedNovember 25, 2024
Main results expectedNovember 2027
Study endsNovember 2027
Registry record updatedDecember 1, 2025
Trial IDNCT06457451 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.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.