Physical Activity Profile and Sedentary Behaviour in Adults with Cystic Fibrosis

Recruiting

• Conditions: Cystic Fibrosis
• Interventions: Other: Characterize the physical activity and sedentary lifestyle profile of adults with cystic fibrosis

• Registration Number: NCT06507956
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-16
• Study First Posted: 2024-07-18
• Study Start: 2024-09-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-07
• Primary Completion: 2025-09-03
• Study Completion: 2026-03-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 270

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults with cystic fibrosis followed at Hôpital Lyon Sud's cystic fibrosis center-single-arm study.	Characterize the physical activity and sedentary lifestyle profile of adults with cystic fibrosis	-

Primary Outcome Measures

Name	Time	Method
Physical activity and sedentary levels will be quantified by the weekly time calculation of moderate physical activity	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	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
Physical activity and sedentary levels will be quantified by the weekly time calculation of high-intensity physical activity	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	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
Physical activity and sedentary levels will be quantified by the weekly time calculation of 2. Sedentary activity	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	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

Trial Locations

Locations (1)

Hôpital Lyon Sud; 🇫🇷 Pierre-Bénite, France