Rheumatoid Arthritis Clinical Trial
— ImBAIAOfficial 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
NCT number | NCT04426747 |
Other study ID # | 2019 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2019 |
Est. completion date | October 30, 2020 |
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | October 30, 2020 |
Est. primary completion date | November 16, 2019 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: 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. |
Country | Name | City | State |
---|---|---|---|
France | Laure Gossec | Paris |
Lead Sponsor | Collaborator |
---|---|
Groupe Hospitalier Pitie-Salpetriere |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | Collected on the last full week at inclusion |
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