Clinical trial NCT05206097: Determinants of Daily Physical Activity Level in Patients With Cystic Fibrosis - Pilot Study Protocol
Official title: Determinants of Daily Physical Activity Level in Patients With Cystic Fibrosis - Pilot Study. Protocol
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
barriers and facilitators
daily physical activity
accelerometry
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 87
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of the study is to analyze the determinants (barriers and facilitators) of the daily physical activity level in a population of patients with cystic fibrosis. A population of patients will be included in order to realize an assessment of their daily physical activity level over an entire week. A specific questionnaire, designed from 3 different questionnaires, will be associated to the physical activity evaluation and will allow to asses psycho-social and environmental factors.

Detailed description: Physical activity (PA) is a major component of the management of patients with cystic fibrosis (CF). Regular PA is associated, in cystic fibrosis as in other pathologies, with health benefits and a greater life expectancy. However, the literature shows an absence of consensus for the daily PA level reached by CF patients, and also for the determinants of this PA level. It appears that CF patients tend to have a reduced PA level, compared to international guidelines. Some determinants have already been mentioned, like physical, psychological or organizational factors. But these factors have not been considered in a multifactorial way, by also considering social and environmental factors, and are rarely associated with objective PA level measurement or only reported in paediatric population. A better comprehension of these determinants of daily PA level represents an important issue for the optimization of interventions designed for the promotion of PA in cystic fibrosis.

For this study, a population of CF patients will realize an evaluation of their daily PA level based on accelerometry (by wearing a portable device over 7 days). During the PA assessment, patients will have a questionnaire to fill in, delivered with the sensor. The objective assessment of PA level will be analyzed with regard to various parameters from different dimensions: individual, clinical, psycho-social and environmental. Individual and clinical parameters will be collected from patients' data routinely assessed for the management of patients. Psycho-social and environmental parameters will be assessed with a specific questionnaire, specifically designed from 3 different questionnaires.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of cystic fibrosis confirmed by the identification of genetic mutation and/or positive sweat test
* regular follow-up in CF centers ;
* age higher than 6 years old
* stable clinical status, away from exacerbation period or antibiotic treatment.

Exclusion Criteria:

* transplant patient or patient waiting for a transplant
* inability to fill in the questionnaire or to complete the planned evaluations
* ongoing participation in another research protocol (interventional study)
* refusal to participate in the study
* patient under legal protection.

Primary outcomes:
measure: Physical Activity Time
timeFrame: Week 1
Secondary outcomes:
measure: Daily Physical Activity level
timeFrame: Week 1
measure: Duration of Physical Activity
timeFrame: Week 1
measure: Frequency of Physical Activity
timeFrame: Week 1
measure: Type of Physical Activity
timeFrame: Week 1
measure: Sedentarity time
timeFrame: Week 1
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU DE BORDEAUX Hôpital des Enfants-Pellegrin - CRCM Pédiatrique
city: Bordeaux
country: France
facility: CHU DE BORDEAUX Hôpital Haut-Lévêque - CRCM Adulte
city: Limoges
country: France
facility: CHU DE LIMOGES Hôpital Dupuytren 2 - CRCM Adulte
city: Limoges
country: France
facility: CHU DE LIMOGES Hôpital Mère Enfant - CRCM Pédiatrique
city: Toulouse
country: France
facility: CHU DE TOULOUSE Hôpital des Enfants - CRCM Pédiatrique
city: Toulouse
country: France
facility: CHU DE TOULOUSE Hôpital Larrey - CRCM Adulte
Study officials:
References: