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

NCT05206097 | Active Not Recruiting

• 1 other identifier: 87RI20_0010 (APM)
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 6

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.

Conditions

Cystic Fibrosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Daily Physical Activity level

  Week 1

• Duration of Physical Activity

  Week 1

• Frequency of Physical Activity

  Week 1

• Type of Physical Activity

  Week 1

• Sedentarity time

  Week 1

Study Arms (1)

Physical Activity Program

EXPERIMENTAL

Device: Accelerometer

Interventions

Accelerometer 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.

Physical Activity Program

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (6)

CHU DE BORDEAUX Hôpital des Enfants-Pellegrin - CRCM Pédiatrique

Bordeaux, 33056, France

Location

CHU DE BORDEAUX Hôpital Haut-Lévêque - CRCM Adulte

Bordeaux, 33600, France

Location

CHU DE LIMOGES Hôpital Dupuytren 2 - CRCM Adulte

Limoges, 87042, France

Location

CHU DE LIMOGES Hôpital Mère Enfant - CRCM Pédiatrique

Limoges, 87042, France

Location

CHU DE TOULOUSE Hôpital des Enfants - CRCM Pédiatrique

Toulouse, 31059, France

Location

CHU DE TOULOUSE Hôpital Larrey - CRCM Adulte

Toulouse, Dr, France

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 25, 2022
• Study Start: September 19, 2022
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

FR (6)