NCT06507956 Physical Activity Profile and Sedentary Behaviour in Adults With Cystic Fibrosis
| NCT ID | NCT06507956 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Cystic Fibrosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 270 participants |
| Start Date | 2024-09-17 |
| Primary Completion | 2026-09-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 270 participants in total. It began in 2024-09-17 with a primary completion date of 2026-09-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Cystic fibrosis is a multisystem genetic disease whose severity, linked to the nature of the mutation in the gene carried, is linked to respiratory impairment, which determines the vital prognosis. Considerable progress has been made in the management of this disease, amplified in recent years by the arrival of CFTR (cystic fibrosis transmembrane conductance regulator) modulator drugs, and in particular the triple treatment combination of elexacaftor-tezacaftor-ivacaftor (ETI). This modulator therapy improves clinical condition, particularly respiratory, and transforms quality of life and prognosis for some patients. Faced with this clinical improvement, practices and care paths are adapting. Professionals will have to cope with the emergence of new clinical conditions linked to the ageing of this at-risk population and the functional decline due to a sedentary lifestyle and age. The working hypothesis is that a better understanding of the physical activity and sedentary lifestyle profiles of the adult population with cystic fibrosis, and in particular the characterization of the profile of inactive and high sedentary patients under ETI, will enable us to identify and target patients whose lifestyle habits reflect a greater health risk, and for whom care by rehabilitators and adapted physical activity (APA) teachers and personalized advice could be put in place. The aim of this study is to characterize the physical activity and sedentary profile of adults with cystic fibrosis. ACTIVMUCO is an observational, cross-sectional, single-center study. A subgroup of adults with high sedentary and inactive under ETI will be studied more specifically by actimetry (prospective follow-up) and interview.
Eligibility Criteria
Inclusion Criteria: * Patients (male or female) of legal age, * Patients with cystic fibrosis (CF) regularly followed at Hôpital Lyon Sud's cystic fibrosis center, who volunteered to take part in the study. Exclusion Criteria: * People who, due to the presence of co-morbidities, do not have motor and cognitive skills compatible with independent walking or orthostatic physical activity. * People whose clinical situation contraindicates the practice of adapted physical activity * Pregnant women * People who do not have the intellectual or linguistic capacity to understand the questionnaires * Persons deprived of their liberty by judicial or administrative decision * Persons under psychiatric care * Persons admitted to a health or social establishment for purposes other than research * Adults under legal protection (guardianship, curatorship). * Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
Contact & Investigator
Raquel Sandra REIS DE CASTRO AZEVEDO
✉ raquel-sandra.reis-de-castro-azevedo@chu-lyon.fr📞 00334 78 86 28 71
Frequently Asked Questions
Who can join the NCT06507956 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Cystic Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06507956 currently recruiting?
Yes, NCT06507956 is actively recruiting participants. Contact the research team at raquel-sandra.reis-de-castro-azevedo@chu-lyon.fr for enrollment information.
Where is the NCT06507956 trial being conducted?
This trial is being conducted at Pierre-Bénite, France.
Who is sponsoring the NCT06507956 clinical trial?
NCT06507956 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 270 participants.