Exercise and diet program for adults with cystic fibrosis on modulator therapy
Tests a combined diet and exercise program in adults with cystic fibrosis taking elexacaftor-tezacaftor-ivacaftor.
Plain-language title generated from the registry record
Registry title: Impact of a Coordinated Dietetic-adapted Physical Activity Program on the Percentage of Lean Body Mass in Adults With Cystic Fibrosis Treated With Elexacaftor-Tezacaftor-Ivacaftor: Multicentre Randomised Controlled Trial
Key facts
- Where
- Angers, Roscoff, Tours, and Vannes, FranceSee the 4 sites
Where in France
- Cystic Fibrosis Resource and Competence Centre, University Hospital, AngersAngers, FranceTaking people
- Cystic Fibrosis Resource and Competence Centre, Fondation Ildys, RoscoffRoscoff, FranceTaking people
- Cystic Fibrosis Resource and Competence Centre, University Hospital, ToursTours, FranceTaking people
- Cystic Fibrosis Resource and Competence Centre, Hospital, ToursVannes, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Tours
- Trial code
- NCT06457451
- Record updated
- 1 December 2025
- Original description
Cystic fibrosis is an autosomal recessive inherited disease linked to various mutations in the gene coding for the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) protein, with respiratory and digestive disorders conditioning the prognosis.Read full original descriptionShow less
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
Cystic fibrosis is an autosomal recessive inherited disease linked to various mutations in the gene coding for the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) protein, with respiratory and digestive disorders conditioning the prognosis.
Digestive damage may be responsible for malnutrition of multifactorial origin (insufficient energy intake, increased energy losses, increased basal metabolic rate), and studies show a correlation between reduced lean body mass and respiratory function.
In 2019, the French National Authority for Health (HAS) redefined undernutrition by including "quantified reduction in muscle mass and/or function" as a phenotypic diagnostic criterion.
Elexacaftor-Tezacaftor-Ivacaftor, an innovative therapy (authorization in 2021) for this population, aims to restore the function of CFTR protein. Significant improvements in lung function and weight gain were observed from the first weeks of treatment. These improvements have also led to the emergence of lesser-known nutritional problems in these patients, such as overweight and the development of metabolic complications. Nonetheless, new management options in terms of dietary adjustments and adapted physical activity for these patients are possible, given the development of their abilities.
Adapted Physical Activity (APA) helps to improve general muscular function by strengthening respiratory and skeletal muscles, improving aerobic capacity, and aiding bronchial drainage through muscle strengthening and endurance work. Maintaining or even increasing muscle mass depends not only on appropriate food intake and optimal dietary management, but also on regular physical activity, as recommended by the HAS.
Our hypothesis is therefore that a structured dietetic/adapted physical activity program (DIAPASOM program) can increase the percentage of lean body mass at 12 months in adult cystic fibrosis patients treated with Elexacaftor-Tezacaftor-Ivacaftor.
Inclusion: 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: 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.