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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

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Tours
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In plain words

What the trial is, and whether it could suit you

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 w

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • DIAPASOM program
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Where

4 sites
Cystic Fibrosis Resource and Competence Centre, University Hospital, Angers
Angers, France
Cystic Fibrosis Resource and Competence Centre, Fondation Ildys, Roscoff
Roscoff, France
Cystic Fibrosis Resource and Competence Centre, University Hospital, Tours
Tours, France
Cystic Fibrosis Resource and Competence Centre, Hospital, Tours
Vannes, France
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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