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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DIAPASOM program.
- Who it may be relevant to
- Registry conditions: Cystic Fibrosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed 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.
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.
Interventions
- Other DIAPASOM program
A program of adapted physical activity carried out remotely by a specialist instructor, combined with personalized dietetic care by a dietician for one year.
Primary outcome measures
- Evolution of percentage of patients lean mass as a percentage of body mass [Time frame: From randomization, up to 12 months]
Secondary outcome measures (12)
- Evolution of percentage of patients fat mass as a percentage of body mass [Time frame: From randomization, up to 12 months]
- Weight evolution [Time frame: From randomization, up to 12 months]
- Body Mass Index (BMI) evolution [Time frame: From randomization, up to 12 months]
- Cardio-respiratory endurance [Time frame: From randomization, up to 12 months]
- Bilateral Handgrip strength [Time frame: From randomization, up to 12 months]
- Lower limb muscle power [Time frame: From randomization, up to 12 months]
- Upper limb muscle power [Time frame: From randomization, up to 12 months]
- Static trunck extensors muscle endurance [Time frame: From randomization, up to 12 months]
- Static trunck flexors muscle endurance [Time frame: From randomization, up to 12 months]
- Balance between static muscular endurance of extensors and flexors [Time frame: From randomization, up to 12 months]
- Posterior chain flexibility (Hamstring, hips and lower back) [Time frame: From randomization, up to 12 months]
- Upper limb flexibility [Time frame: From randomization, up to 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
France · 4 centers
- Cystic Fibrosis Resource and Competence Centre, University Hospital, Angers — Angers
- Cystic Fibrosis Resource and Competence Centre, Fondation Ildys, Roscoff — Roscoff
- Cystic Fibrosis Resource and Competence Centre, University Hospital, Tours — Tours
- Cystic Fibrosis Resource and Competence Centre, Hospital, Tours — Vannes
Identifiers
NCT: NCT06457451 · 2023-A02715-40 · DR220270