Physical Activity Profile and Sedentary Behaviour in Adults With Cystic Fibrosis
NCT Number: NCT06507956
Acronym: ACTIVMUCO
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cystic Fibrosis
Interventions: OTHER: Characterize the physical activity and sedentary lifestyle profile of adults with cystic fibrosis
Sponsor: Hospices Civils de Lyon
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 270
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-03
Completion Date: 2026-03-03
Locations: Hôpital Lyon Sud, Pierre-Bénite, 69310, France

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.

Primary Outcome Measures: Physical activity and sedentary levels will be quantified by the weekly time calculation of moderate physical activity, Moderate physical activity self-reported and reported in METs (Metabolic Equivalent of Task).minutes/week on the ONAPS-PAQ questionnaire, then categorized into 3 physical activity profiles:

1. Inactive individual
2. Active individual
3. Very active individual, For each subject : day 1 for the cross-sectional questionnaire study - 3 months to 6 months (next consultation at the CF center) and 1 week for the subgroup monitored by accelerometry|Physical activity and sedentary levels will be quantified by the weekly time calculation of high-intensity physical activity, High-intensity physical activity self-reported and reported in METs (Metabolic Equivalent of Task).minutes/week on the ONAPS-PAQ questionnaire, then categorized into 3 physical activity profiles:

1. Inactive individual
2. Active individual
3. Very active individual, For each subject : day 1 for the cross-sectional questionnaire study - 3 months to 6 months (next consultation at the CF center) and 1 week for the subgroup monitored by accelerometry|Physical activity and sedentary levels will be quantified by the weekly time calculation of 2. Sedentary activity, Sedentary activity self-reported and reported in daily average (hours/day) on the ONAPS-PAQ questionnaire, then categorized into sedentary levels:

1. Low
2. Moderate
3. High, For each subject : day 1 for the cross-sectional questionnaire study - 3 months to 6 months (next consultation at the CF center) and 1 week for the subgroup monitored by accelerometry