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NCT Number: NCT06507956

Physical Activity Profile and Sedentary Behaviour in Adults With Cystic Fibrosis

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.

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Key information

Conditions

Cystic Fibrosis Behavior Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Motor Activity Pancreatic Diseases Respiratory Tract Diseases Sedentary Behavior

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Characterize the physical activity and sedentary lifestyle profile of adults with cystic fibrosis

Other

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.

Primary outcomes

  1. 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:

    • Inactive individual
    • Active individual
    • Very active individual

  2. 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:

    • Inactive individual
    • Active individual
    • Very active individual

  3. 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:

    • Low
    • Moderate
    • High

Study contacts

Contact information is provided by the study sponsor or research team.

Quitterie REYNAUD

CONTACT

[email protected]

00334 78 86 13 66

Raquel Sandra REIS DE CASTRO AZEVEDO

CONTACT

[email protected]

00334 78 86 28 71

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: ACTIVMUCO

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 18, 2024
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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