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New treatment option for Cystic Fibrosis
Official title 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
ClinicalTrials.gov ID: NCT06457451
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Roscoff, France
- Tours, France
- Vannes, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Roscoff, France; Tours, France; Vannes, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.