Inflammatory ArthritisImBAIANCT04426747
Impact of Barriers and Facilitators to Physical Activity in Patients With Inflammatory Arthritis
An observational study of Inflammatory Arthritis and Ankylosing Spondylitis, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
Trial summary
Background: Patients with inflammatory arthritis (IA), such as spondyloarthritis (axSpA), rheumatoid arthritis (RA) or psoriatic arthritis (PsA) are more prone to physical inactivity but derive specific benefits from regular physical activity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Arthritis, Ankylosing Spondylitis, Rheumatoid Arthritis
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2019to 30 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Adult, Older adult
Study population: Outpatients from secondary and tertiary care hospitals in France and in the United Kingdom will be invited to participate. Over the 5 months recruitment period, all patients with definite axSpA, RA or PsA who satisfy the inclusion criteria, seen in outpatient visits in the participating centers by one of the investigators, will be asked to participate. We plan to include 200 participants (based on a sample size calculation explained in statistical analysis part), 10-20 patients in each center, with a maximum of 30 patients per center and a competitive recruitment. We will aim for a minimum of 50 patients per disease group. After including of 50% of the population we will reorient inclusion if needed. Data will be collected at a single moment, during a usual visit.
Who may be able to join
- aged above 18 and able to walk
- Definite IA confirmed by the rheumatologist and based on usual criteria: axSpA (referring to the Assessment of Spondyloarthritis international Society classification criteria (51)), RA (referring to the international classification criteria of RA (52)) or PsA (referring to the ClASsification of Psoriatic Arthritis (CASPAR) criteria (53)), with no restriction for co-morbidities,
- have a mobile phone compatible with apps that can track steps,
- agree to participate and give informed consent,
- ability to read and write in the language of participating country.
Who cannot join
- Patients who don't speak or read the local language or are not comfortable filling in a Case Report Form in the local language or who don't have a mobile phone compatible with health apps.
Trial locations and contacts
1 site in 1 country.
Bruno Fautrel, Pr contact
France1 site, 1 recruiting
- Recruiting
Laure Gossec
Paris, 75013
Laure Gossec, +331 42 17 84 21, laure.gossec@aphp.fr
About this study
Official title: Impact of Barriers and Facilitators to Physical Activity in Patients With Inflammatory Arthritis and Link With Physical Activity Collected by Mobile Phone Apps: a Cross-sectional Study
Background: Patients with inflammatory arthritis (IA), such as spondyloarthritis (axSpA), rheumatoid arthritis (RA) or psoriatic arthritis (PsA) are more prone to physical inactivity but derive specific benefits from regular physical activity. Barriers and facilitators to physical activity (B\&F-PA) are key elements and knowledge of their correlation to physical activity is essential for developing interventions to promote physical activity that have a greater likelihood of success.
Objectives: primary objective will be to measure the correlation of these B\&F-PA to physical activity collected through apps. Secondary objective will be to (I) to quantify physical activity collected through apps in IA patients and (II) to observe the link between physical activity, B\&F to physical activity and adherence to treatment.
Read more
Patients and methods: This is an international, multicentric, cross-sectional study.
Patients: From the first of September to the first of February 2020, all patients with definite axSpA, RA or PsA, aged above 18 and able to walk, who have a mobile phone compatible with apps that can track steps, who agree to participate and give his oral informed consent and with ability to read and write in the language of the participating country, seen in outpatient visits in the participating centers, will be asked to participate. The planed inclusion was 200 participants.
Data collection: clinical data and information about physical activity and B\&F-PA will be entered by rheumatologists during or electronically by patients at the same time point.
Questionnaire for B\&F-PA: a patient reported questionnaire was recently developed for this study in 2019 based on a systematic review to identify the main B\&F-PA. A list of questions was generated from the systematic review reviewed and tested for face validity by 11 experts and confronted to 20 patients with IA through a cognitive debriefing.
Physical activity: Physical activity will be measured objectively during the last 7 days by apps already installed by default on the mobile phone of participants and subjectively with the International Physical Activity Questionnaire short version (IPAQ-S).
Other outcomes: Stage of exercise behavior change and adherence to treatment will also be collected.
Planned analyses: Perceived B\&F-PA will be described using frequencies. A score will be calculated for each participant representing the limitations or facilities to perform physical activity.
Analysis of the physical activity: The distribution of mean number of steps will be assessed visually for outliers. Univariate analysis will be completed between mean number of steps and gender, age, disease and stages of change. Correlation between mean number of steps and IPAQ-S score will be calculated.
Link between physical activity and barriers and facilitators: The link between B\&F questionnaire score and mean number of steps will be tested using linear regression. Then multivariate regression including demographic variables, psychological status and disease characteristics will be performed.
Outcomes of the study: The expected outcomes of the ImBAIA study are a better understanding of B\&F to physical activity in patients with IA and their impact to limit or to favor physical activity. We also expect to observe the level of physical activity of an IA population objectively measured with apps. Finally, a validation was expected to use questionnaire of B\&F.
- Being tested
- No intervention
- Keywords
- Physical activity, Barriers, Facilitators
- Medical subject headings
- Arthritis, Spondylitis, Ankylosing, Arthritis, Rheumatoid, Arthritis, Psoriatic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity (mean steps per day on the last full week (1 week) at inclusion)
Physical activity objectively measured by patient's mobile phone at inclusion during the last full week (1 week)
Measured: Collected on the last full week at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Sep 2019
- Primary completion16 Nov 2019
- Study completion30 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory ArthritisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laure Gossec, Groupe Hospitalier Pitie-Salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426747
- Sponsor's protocol ID
- 2019
- Acronym
- ImBAIA
- Status last verified
- Jun 2020
- First submitted
- 5 Dec 2019
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Davergne T, Tekaya R, Sellam J, Tournadre A, Mitrovic S, Ruyssen-Witrand A, Hudry C, Dadoun S, Avouac J, Fautrel B, Gossec L. Influence of perceived barriers and facilitators for physical activity on physical activity levels in patients with rheumatoid arthritis or spondyloarthritis: a cross-sectional study of 150 patients. BMC Musculoskelet Disord. 2021 Oct 30;22(1):915. doi: 10.1186/s12891-021-04792-7.
PubMed 34717606
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Barriers and Facilitators to Physical Activity in Patients With Inflammatory Arthritis and Link With Physical Activity Collected by Mobile Phone Apps: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04426747
- Acronym / sponsor ID
- ImBAIA / 2019
- Keywords
- Physical activity, Barriers, Facilitators
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 16 Nov 2019 (actual)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 11 Jun 2020 (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.
Background: Patients with inflammatory arthritis (IA), such as spondyloarthritis (axSpA), rheumatoid arthritis (RA) or psoriatic arthritis (PsA) are more prone to physical inactivity but derive specific benefits from regular physical activity. Barriers and facilitators to physical activity (B\&F-PA) are key elements and knowledge of their correlation to physical activity is essential for developing interventions to promote physical activity that have a greater likelihood of success.
Objectives: primary objective will be to measure the correlation of these B\&F-PA to physical activity collected through apps. Secondary objective will be to (I) to quantify physical activity collected through apps in IA patients and (II) to observe the link between physical activity, B\&F to physical activity and adherence to treatment.
Patients and methods: This is an international, multicentric, cross-sectional study.
Patients: From the first of September to the first of February 2020, all patients with definite axSpA, RA or PsA, aged above 18 and able to walk, who have a mobile phone compatible with apps that can track steps, who agree to participate and give his oral informed consent and with ability to read and write in the language of the participating country, seen in outpatient visits in the participating centers, will be asked to participate. The planed inclusion was 200 participants.
Data collection: clinical data and information about physical activity and B\&F-PA will be entered by rheumatologists during or electronically by patients at the same time point.
Questionnaire for B\&F-PA: a patient reported questionnaire was recently developed for this study in 2019 based on a systematic review to identify the main B\&F-PA. A list of questions was generated from the systematic review reviewed and tested for face validity by 11 experts and confronted to 20 patients with IA through a cognitive debriefing.
Physical activity: Physical activity will be measured objectively during the last 7 days by apps already installed by default on the mobile phone of participants and subjectively with the International Physical Activity Questionnaire short version (IPAQ-S).
Other outcomes: Stage of exercise behavior change and adherence to treatment will also be collected.
Planned analyses: Perceived B\&F-PA will be described using frequencies. A score will be calculated for each participant representing the limitations or facilities to perform physical activity.
Analysis of the physical activity: The distribution of mean number of steps will be assessed visually for outliers. Univariate analysis will be completed between mean number of steps and gender, age, disease and stages of change. Correlation between mean number of steps and IPAQ-S score will be calculated.
Link between physical activity and barriers and facilitators: The link between B\&F questionnaire score and mean number of steps will be tested using linear regression. Then multivariate regression including demographic variables, psychological status and disease characteristics will be performed.
Outcomes of the study: The expected outcomes of the ImBAIA study are a better understanding of B\&F to physical activity in patients with IA and their impact to limit or to favor physical activity. We also expect to observe the level of physical activity of an IA population objectively measured with apps. Finally, a validation was expected to use questionnaire of B\&F.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Outpatients from secondary and tertiary care hospitals in France and in the United Kingdom will be invited to participate. Over the 5 months recruitment period, all patients with definite axSpA, RA or PsA who satisfy the inclusion criteria, seen in outpatient visits in the participating centers by one of the investigators, will be asked to participate. We plan to include 200 participants (based on a sample size calculation explained in statistical analysis part), 10-20 patients in each center, with a maximum of 30 patients per center and a competitive recruitment. We will aim for a minimum of 50 patients per disease group. After including of 50% of the population we will reorient inclusion if needed. Data will be collected at a single moment, during a usual visit.
Key inclusion criteria (5 listed)
- aged above 18 and able to walk
- Definite IA confirmed by the rheumatologist and based on usual criteria: axSpA (referring to the Assessment of Spondyloarthritis international Society classification criteria (51)), RA (referring to the international classification criteria of RA (52)) or PsA (referring to the ClASsification of Psoriatic Arthritis (CASPAR) criteria (53)), with no restriction for co-morbidities,
- have a mobile phone compatible with apps that can track steps,
- agree to participate and give informed consent,
- ability to read and write in the language of participating country.
Key exclusion criteria (1 listed)
- Patients who don't speak or read the local language or are not comfortable filling in a Case Report Form in the local language or who don't have a mobile phone compatible with health apps.
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 |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Physical activity (mean steps per day on the last full week (1 week) at inclusion)
Time frame: Collected on the last full week at inclusion
Physical activity objectively measured by patient's mobile phone at inclusion during the last full week (1 week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Derived from this study: PubMed 34717606Davergne T, Tekaya R, Sellam J, Tournadre A, Mitrovic S, Ruyssen-Witrand A, Hudry C, Dadoun S, Avouac J, Fautrel B, Gossec L. Influence of perceived barriers and facilitators for physical activity on physical activity levels in patients with rheumatoid arthritis or spondyloarthritis: a cross-sectional study of 150 patients. BMC Musculoskelet Disord. 2021 Oct 30;22(1):915. doi: 10.1186/s12891-021-04792-7.
- Individual participant dataSharing planned: No
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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.
Bruno Fautrel, Pr contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Arthritis and Ankylosing Spondylitis, run by Groupe Hospitalier Pitie-Salpetriere at 1 site 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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Davergne, PT (+33675976781, thomas.davergne@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (mean steps per day on the last full week (1 week) at inclusion) (time frame: Collected on the last full week at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04426747, which also lists 1 linked publication.
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 11 Jun 2020.