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

Sponsor

University Hospital, Limoges (Other)

Overall Status

Recruiting

CT.gov ID

NCT05206097

Collaborator

(none)

100

Enrollment

Locations

Arm

12.3

Anticipated Duration (Months)

16.7

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis	Device: Accelerometer	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

May 23, 2022

Anticipated Primary Completion Date :

Jun 2, 2023

Anticipated Study Completion Date :

Jun 2, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Physical Activity Time [Week 1]
mean value of moderate to vigorous Physical Activity (MVPA) time (min/day), from an accelerometry evaluation over an entire week

Secondary Outcome Measures

Daily Physical Activity level [Week 1]
Daily Physical Activity level, from the accelerometry evaluation compared to international PA guidelines
Duration of Physical Activity [Week 1]
Duration of Physical Activity performed by patients
Frequency of Physical Activity [Week 1]
Frequency of Physical Activity performed by patients
Type of Physical Activity [Week 1]
Type of Physical Activity performed by patients
Sedentarity time [Week 1]
Sedentarity time, from the accelerometry evaluation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU DE BORDEAUX Hôpital des Enfants-Pellegrin - CRCM Pédiatrique	Bordeaux	France	33056
2	CHU DE BORDEAUX Hôpital Haut-Lévêque - CRCM Adulte	Bordeaux	France	33600
3	CHU DE LIMOGES Hôpital Dupuytren 2 - CRCM Adulte	Limoges	France	87042
4	CHU DE LIMOGES Hôpital Mère Enfant - CRCM Pédiatrique	Limoges	France	87042
5	CHU DE TOULOUSE Hôpital des Enfants - CRCM Pédiatrique	Toulouse	France	31059
6	CHU DE TOULOUSE Hôpital Larrey - CRCM Adulte	Toulouse	France	Dr