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

Primary Purpose

Cystic Fibrosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Accelerometer
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, barriers and facilitators, daily physical activity, accelerometry

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • CHU DE BORDEAUX Hôpital des Enfants-Pellegrin - CRCM Pédiatrique
  • CHU DE BORDEAUX Hôpital Haut-Lévêque - CRCM Adulte
  • CHU DE LIMOGES Hôpital Dupuytren 2 - CRCM AdulteRecruiting
  • CHU DE LIMOGES Hôpital Mère Enfant - CRCM PédiatriqueRecruiting
  • CHU DE TOULOUSE Hôpital des Enfants - CRCM Pédiatrique
  • CHU DE TOULOUSE Hôpital Larrey - CRCM Adulte

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physical Activity Program

Arm Description

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
January 10, 2022
Last Updated
May 30, 2022
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT05206097
Brief Title
Determinants of Daily Physical Activity Level in Patients With Cystic Fibrosis - Pilot Study Protocol
Acronym
APM
Official Title
Determinants of Daily Physical Activity Level in Patients With Cystic Fibrosis - Pilot Study. Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2022 (Anticipated)
Primary Completion Date
June 2, 2023 (Anticipated)
Study Completion Date
June 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Cystic Fibrosis, barriers and facilitators, daily physical activity, accelerometry

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical Activity Program
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Accelerometer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical Activity Time
Description
mean value of moderate to vigorous Physical Activity (MVPA) time (min/day), from an accelerometry evaluation over an entire week
Time Frame
Week 1
Secondary Outcome Measure Information:
Title
Daily Physical Activity level
Description
Daily Physical Activity level, from the accelerometry evaluation compared to international PA guidelines
Time Frame
Week 1
Title
Duration of Physical Activity
Description
Duration of Physical Activity performed by patients
Time Frame
Week 1
Title
Frequency of Physical Activity
Description
Frequency of Physical Activity performed by patients
Time Frame
Week 1
Title
Type of Physical Activity
Description
Type of Physical Activity performed by patients
Time Frame
Week 1
Title
Sedentarity time
Description
Sedentarity time, from the accelerometry evaluation.
Time Frame
Week 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra MASSON-ROUCHAUD, Dr
Phone
+ 33 (0) 555 058 669
Email
Alexandra.Masson-Rouchaud@chu-limoges.fr
Facility Information:
Facility Name
CHU DE BORDEAUX Hôpital des Enfants-Pellegrin - CRCM Pédiatrique
City
Bordeaux
ZIP/Postal Code
33056
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphanie BUI-MECHAIN, Dr
Facility Name
CHU DE BORDEAUX Hôpital Haut-Lévêque - CRCM Adulte
City
Bordeaux
ZIP/Postal Code
33600
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie MACEY, Dr
Facility Name
CHU DE LIMOGES Hôpital Dupuytren 2 - CRCM Adulte
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magali DUPUY-GRASSET, Dr
Facility Name
CHU DE LIMOGES Hôpital Mère Enfant - CRCM Pédiatrique
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra MASSON-ROUCHAUD, Dr
Facility Name
CHU DE TOULOUSE Hôpital des Enfants - CRCM Pédiatrique
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Géraldine LABOURET, Dr
Facility Name
CHU DE TOULOUSE Hôpital Larrey - CRCM Adulte
City
Toulouse
ZIP/Postal Code
Dr
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marlène MURRIS-ESPIN, Dr

12. IPD Sharing Statement

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

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