Determinants of Daily Physical Activity Level in Patients With Cystic Fibrosis - Pilot Study Protocol

Cystic Fibrosis Clinical Trial

— APM  

Official title:

Determinants of Daily Physical Activity Level in Patients With Cystic Fibrosis - Pilot Study. Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05206097
• Other study ID #: 87RI20_0010 (APM)
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2022
• Est. completion date: June 2, 2023

Study information

• Verified date: May 2022
• Source: University Hospital, Limoges
• Contact: Alexandra MASSON-ROUCHAUD, Dr
• Phone: + 33 (0) 555 058 669
• Email: Alexandra.Masson-Rouchaud[@]chu-limoges.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2, 2023
• Est. primary completion date: June 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Device:
• Accelerometer
For the following study, each patient will be asked to wear a portable device over a 7-day period. The accelerometer will be previously set up according to anthropometric data of the patient and scheduled to automatically start and stop accelerations registration. The patient will be asked to wear the sensor as frequently as possible, with the exception of sleep period and during aquatic activities. A diary will be delivered to the patient in order to notify any problem/issue observed during the evaluation week (for example forgetting to wear the sensor). The accelerometry assessment will be associated to a questionnaire. Each patient will have to fill in it during the evaluation week. The questionnaire is composed of various questions from three different questionnaires: Ricci & Gagnon for subjective evaluation of PA level, CFQ-14+ for the evaluation of quality of life specifically in CF and EQ-5D for a more generic evaluation of quality of life.

Locations

Country	Name	City	State
France	CHU DE BORDEAUX Hôpital des Enfants-Pellegrin - CRCM Pédiatrique	Bordeaux
France	CHU DE BORDEAUX Hôpital Haut-Lévêque - CRCM Adulte	Bordeaux
France	CHU DE LIMOGES Hôpital Dupuytren 2 - CRCM Adulte	Limoges
France	CHU DE LIMOGES Hôpital Mère Enfant - CRCM Pédiatrique	Limoges
France	CHU DE TOULOUSE Hôpital des Enfants - CRCM Pédiatrique	Toulouse
France	CHU DE TOULOUSE Hôpital Larrey - CRCM Adulte	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity Time	mean value of moderate to vigorous Physical Activity (MVPA) time (min/day), from an accelerometry evaluation over an entire week	Week 1
Secondary	Daily Physical Activity level	Daily Physical Activity level, from the accelerometry evaluation compared to international PA guidelines	Week 1
Secondary	Duration of Physical Activity	Duration of Physical Activity performed by patients	Week 1
Secondary	Frequency of Physical Activity	Frequency of Physical Activity performed by patients	Week 1
Secondary	Type of Physical Activity	Type of Physical Activity performed by patients	Week 1
Secondary	Sedentarity time	Sedentarity time, from the accelerometry evaluation.	Week 1