Physical Activity Profile and Sedentary Behaviour in Adults With Cystic Fibrosis (ACTIVMUCO)

November 18, 2025 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

270

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants (male or female of legal age, with cystic fibrosis - CF) are recruited from the active file of adult patients followed at the CF Reference Center of Hôpital Lyon Sud, from the Rhône-Alpes region of France. They must be volunteers to participate in the study. The study ACTIVMUCO is carried out at the time of the patient's scheduled visit, on site, without impacting the dynamics of the care pathway, on an active file of around 430 patients. The regularity of these outpatient visits to the CF center is between 1 and 4 times a year, depending on the patient's clinical condition. The number of patients to be recruited is 270. The number of patients followed regularly over the past year was 434, including 85 transplant patients and 20 new patients. Over the 12-month recruitment period, the department estimates that around 80% of patients followed will actually come for day hospitalization

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adults with cystic fibrosis followed at Hôpital Lyon Sud's cystic fibrosis center-single-arm study.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity and sedentary levels will be quantified by the weekly time calculation of moderate physical activity
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2024

Primary Completion (Estimated)

September 3, 2026

Study Completion (Estimated)

March 3, 2027

Study Registration Dates

First Submitted

July 10, 2024

First Submitted That Met QC Criteria

July 16, 2024

First Posted (Actual)

July 18, 2024

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL23_1132
  • 2024-A01077-40 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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