Cystic FibrosisAPMNCT05206097
Determinants of Daily Physical Activity Level in Patients With Cystic Fibrosis - Pilot Study Protocol
A study testing Accelerometer in people with Cystic Fibrosis, run by University Hospital, Limoges at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Accelerometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 6 sitesFrance
- Study dates
- 19 Sep 2022to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU DE BORDEAUX Hôpital des Enfants-Pellegrin - CRCM Pédiatrique
Bordeaux, 33056
CHU DE BORDEAUX Hôpital Haut-Lévêque - CRCM Adulte
Bordeaux, 33600
CHU DE LIMOGES Hôpital Dupuytren 2 - CRCM Adulte
Limoges, 87042
CHU DE LIMOGES Hôpital Mère Enfant - CRCM Pédiatrique
Limoges, 87042
CHU DE TOULOUSE Hôpital des Enfants - CRCM Pédiatrique
Toulouse, 31059
CHU DE TOULOUSE Hôpital Larrey - CRCM Adulte
Toulouse, Dr
About this study
Official title: 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.
Read the 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
- Being tested
- Accelerometer
- Keywords
- Cystic Fibrosis, barriers and facilitators, daily physical activity, accelerometry
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccelerometerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Program | Experimental | Not described Receives: Device: Accelerometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Time
mean value of moderate to vigorous Physical Activity (MVPA) time (min/day), from an accelerometry evaluation over an entire week
Measured: Week 1
Secondary outcomes (5)
Daily Physical Activity level
Daily Physical Activity level, from the accelerometry evaluation compared to international PA guidelines
Measured: Week 1
Duration of Physical Activity
Duration of Physical Activity performed by patients
Measured: Week 1
Frequency of Physical Activity
Frequency of Physical Activity performed by patients
Measured: Week 1
Type of Physical Activity
Type of Physical Activity performed by patients
Measured: Week 1
Sedentarity time
Sedentarity time, from the accelerometry evaluation.
Measured: Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start19 Sep 2022
- Primary completion20 Dec 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206097
- Sponsor's protocol ID
- 87RI20_0010 (APM)
- Acronym
- APM
- Status last verified
- Dec 2024
- First submitted
- 10 Jan 2022
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Daily Physical Activity Level in Patients With Cystic Fibrosis - Pilot Study. Protocol
- ClinicalTrials.gov ID
- NCT05206097
- Acronym / sponsor ID
- APM / 87RI20_0010 (APM)
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, barriers and facilitators, daily physical activity, accelerometry
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Program | Experimental | Device: Accelerometer |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AccelerometerFor 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. | Device | Physical Activity Program |
Primary outcome
Physical Activity Time
Time frame: Week 1
mean value of moderate to vigorous Physical Activity (MVPA) time (min/day), from an accelerometry evaluation over an entire week
5 secondary outcomes
Daily Physical Activity level
Time frame: Week 1
Duration of Physical Activity
Time frame: Week 1
Frequency of Physical Activity
Time frame: Week 1
Type of Physical Activity
Time frame: Week 1
Sedentarity time
Time frame: Week 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerometer in people with Cystic Fibrosis, run by University Hospital, Limoges at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Time (time frame: Week 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.