NCT06507956

Physical Activity Profile and Sedentary Behaviour in Adults With Cystic Fibrosis

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 270 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: —

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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
OTHER	Characterize the physical activity and sedentary lifestyle profile of adults with cystic fibrosis	Eligible patients will be presented with the study during a routine care visit CF center, at the end of a physiotherapy, adapted physical activity or nurse session, in accordance with the schedule for the day's visit, with no changes induced by this study. After sufficient time for reflection, patients agreeing to participate will be given self-questionnaires. From this visit, a proposal to participate at V2 will be made only to the inactive and/or hight sedentary patients on the ONAPS-PAQ questionnaire, under elexacaftor-tezacaftor-ivacaftor (ETI). Volunteers will know their participation in either actimetry or a qualitative interview following a draw. At V2, 40 patients will be offered a 7-day longitudinal follow-up by actimetry, and between 10 to 15 patients will take part in an qualitative semi-structured interview identifying motivational barriers and levers for action. At V3, patients monitored by actimetry will be invited to return their actimeter by postage-paid mail.

Timeline

• Start date: 2024-09-17
• Primary completion: 2026-09-03
• Completion: 2027-03-03
• First posted: 2024-07-18
• Last updated: 2025-11-21

Locations

1 site across 1 country: France