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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Cystic Fibrosis Resource and Competence Centre, University Hospital, Angers
RECRUITING
Angers
Cystic Fibrosis Resource and Competence Centre, Fondation Ildys, Roscoff
RECRUITING
Roscoff
Cystic Fibrosis Resource and Competence Centre, University Hospital, Tours
RECRUITING
Tours
Cystic Fibrosis Resource and Competence Centre, Hospital, Tours
RECRUITING
Vannes
Contact Information
Primary
Amelie GIBORY
a.gibory@chu-tours.fr
0247474747
Backup
Arnaud DE LUCA, MD
a.deluca@chu-tours.fr
Time Frame
Start Date: 2024-11-25
Estimated Completion Date: 2027-11
Participants
Target number of participants: 100
Treatments
Experimental: DIAPASOM program
Program of adapted physical activity carried out remotely by a specialized instructor for one year:~* Phase 1 (3 months): 2 supervised weekly sessions.~* Phase 2 (3months): 1 supervised weekly session and 1 independent weekly session.~* Phase 3 (6months): 2 independent weekly sessions with monthly telephone follow-up.~Combined with personalized dietetic care by a dietician for one year too:~In person dietetic consultation every 3 months to monitor personalized objectives, with telephone follow-up between each face-to-face consultation to improve compliance.
No_intervention: Management as usual
Management of nutrition and physical activity as usual
Related Therapeutic Areas
Sponsors
Collaborators: Fondation Ildys
Leads: University Hospital, Tours

This content was sourced from clinicaltrials.gov