Cystic FibrosisACTIVMUCONCT06507956
Physical Activity Profile and Sedentary Behaviour in Adults With Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Characterize the physical activity and sedentary lifestyle profile of adults with cystic fibrosis
- How many people
- 270 participants
- Where
- 1 siteFrance
- Study dates
- 17 Sep 2024to 3 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Raquel Sandra REIS DE CASTRO AZEVEDO contact
France1 site, 1 recruiting
- Recruiting
Hôpital Lyon Sud
Pierre-Bénite, 69310
Raquel Sandra REIS DE CASTRO AZEVEDO, Master Degree, 00334 78 86 28 71, raquel-sandra.reis-de-castro-azevedo@chu-lyon.fr
00334 78 86 28 71, raquel-sandra.reis-de-castro-azevedo@chu-lyon.fr
About this study
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.
Read more
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
- Being tested
- Characterize the physical activity and sedentary lifestyle profile of adults with cystic fibrosis
- Keywords
- Cystic Fibrosis, Exercise, Sedentary lifestyle
- Medical subject headings
- Cystic Fibrosis, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Characterize the physical activity and sedentary lifestyle profile of adults with cystic fibrosisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Adults with cystic fibrosis followed at Hôpital Lyon Sud's cystic fibrosis center-single-arm study. | Not described Receives: Other: Characterize the physical activity and sedentary lifestyle profile of adults with cystic fibrosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Inactive individual
- Active individual
- Very active individual
Measured: 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:
- Inactive individual
- Active individual
- Very active individual
Measured: 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:
- Low
- Moderate
- High
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start17 Sep 2024
- Primary completion3 Sep 2026 (estimated)
- Study completion3 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507956
- Sponsor's protocol ID
- 69HCL23_1132
- Other IDs
- 2024-A01077-40
- Acronym
- ACTIVMUCO
- Status last verified
- Nov 2025
- First submitted
- 10 Jul 2024
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Profile and Sedentary Behaviour in Adults With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT06507956
- Acronym / sponsor ID
- ACTIVMUCO / 69HCL23_1132
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Exercise, Sedentary lifestyle
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 3 Sep 2026 (estimated)
- Study completion
- 3 Mar 2027 (estimated)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Characterize the physical activity and sedentary lifestyle profile of adults with cystic fibrosisEligible 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. | Other | Adults with cystic fibrosis followed at Hôpital Lyon Sud's cystic fibrosis center-single-arm study. |
Primary outcome
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raquel Sandra REIS DE CASTRO AZEVEDO contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raquel Sandra REIS DE CASTRO AZEVEDO (00334 78 86 28 71, raquel-sandra.reis-de-castro-azevedo@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.