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Study identifier: NCT06457451 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Cystic Fibrosis  ·  Sponsor: University Hospital, Tours

PhaseNA
Planned participants100
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 streng…

This description comes directly from the study's public registry record.

Talk to the study team

Amelie GIBORY  ·  0247474747  ·  a.gibory@chu-tours.fr

Arnaud DE LUCA, MD  ·  a.deluca@chu-tours.fr

Always discuss trial participation with your own doctor first.

Locations (4)

Cystic Fibrosis Resource and Competence Centre, University Hospital, AngersAngers, FranceRecruiting
Cystic Fibrosis Resource and Competence Centre, Fondation Ildys, RoscoffRoscoff, FranceRecruiting
Cystic Fibrosis Resource and Competence Centre, University Hospital, ToursTours, FranceRecruiting
Cystic Fibrosis Resource and Competence Centre, Hospital, ToursVannes, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT06457451