NCT06457451 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
| NCT ID | NCT06457451 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Tours |
| Condition | Cystic Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-11-25 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-11-25 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Julie MANKIKIAN, MD
PRINCIPAL INVESTIGATOR
University Hospital, Tours
Frequently Asked Questions
Who can join the NCT06457451 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cystic Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06457451 currently recruiting?
Yes, NCT06457451 is actively recruiting participants. Contact the research team at a.gibory@chu-tours.fr for enrollment information.
Where is the NCT06457451 trial being conducted?
This trial is being conducted at Angers, France, Roscoff, France, Tours, France, Vannes, France.
Who is sponsoring the NCT06457451 clinical trial?
NCT06457451 is sponsored by University Hospital, Tours. The principal investigator is Julie MANKIKIAN, MD at University Hospital, Tours. The trial plans to enroll 100 participants.