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

NCT ID: NCT05206097

Last Updated: 2024-12-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-19
• Study Completion Date: 2024-12-20

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.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; barriers and facilitators; daily physical activity; accelerometry

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Physical Activity Program

Group Type: EXPERIMENTAL

Accelerometer

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Limoges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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, , France

Countries

France

Other Identifiers

87RI20_0010 (APM)

Identifier Type: -

Identifier Source: org_study_id