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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Device: Accelerometer

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexandra MASSON-ROUCHAUD, Dr; Phone Number: + 33 (0) 555 058 669; Email: Alexandra.Masson-Rouchaud@chu-limoges.fr

Study Locations

• France
  • Bordeaux, France, 33056
    • Not yet recruiting
    • CHU DE BORDEAUX Hôpital des Enfants-Pellegrin - CRCM Pédiatrique
    • Contact: Stéphanie BUI-MECHAIN, Dr
  • Bordeaux, France, 33600
    • Not yet recruiting
    • CHU DE BORDEAUX Hôpital Haut-Lévêque - CRCM Adulte
    • Contact: Julie MACEY, Dr
  • Limoges, France, 87042
    • Recruiting
    • CHU DE LIMOGES Hôpital Dupuytren 2 - CRCM Adulte
    • Contact: Magali DUPUY-GRASSET, Dr
  • Limoges, France, 87042
    • Recruiting
    • CHU DE LIMOGES Hôpital Mère Enfant - CRCM Pédiatrique
    • Contact: Alexandra MASSON-ROUCHAUD, Dr
  • Toulouse, France, 31059
    • Not yet recruiting
    • CHU DE TOULOUSE Hôpital des Enfants - CRCM Pédiatrique
    • Contact: Géraldine LABOURET, Dr
  • Toulouse, France, Dr
    • Not yet recruiting
    • CHU DE TOULOUSE Hôpital Larrey - CRCM Adulte
    • Contact: Marlène MURRIS-ESPIN, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Physical Activity Program

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily Physical Activity level	Daily Physical Activity level, from the accelerometry evaluation compared to international PA guidelines	Week 1
Duration of Physical Activity	Duration of Physical Activity performed by patients	Week 1
Frequency of Physical Activity	Frequency of Physical Activity performed by patients	Week 1
Type of Physical Activity	Type of Physical Activity performed by patients	Week 1
Sedentarity time	Sedentarity time, from the accelerometry evaluation.	Week 1

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (Anticipated): May 23, 2022
• Primary Completion (Anticipated): June 2, 2023
• Study Completion (Anticipated): June 2, 2023

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: January 24, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Cystic Fibrosis; accelerometry; daily physical activity; barriers and facilitators
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: 87RI20_0010 (APM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No