Clinical trial NCT03458026: Move Your Spondyl " Better Live Its Rheumatism With the Physical Activity "
Official title: Move Your Spondyl " Better Live Its Rheumatism With the Physical Activity "
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spondyloarthritis
Keywords: activity
Connected object
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
Collaborators: name: LAMHNESS
name: Azur sante
First posted: 2018-03-08
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: By this project, the investigators are going to try to demonstrate that to use objects connected to make a physical activity can have an impact on the clinical activity of the disease by bringing the subjects which present a spondyloarthritis to make a physical activity. The investigators shall show furthermore, than the use of connected objects also has better chances to glue the patients presenting a spondyloarthritis to a practice of regular physical activity that a simple recommendation.

Detailed description: This project is aimed at subjects with Axial Spondyloarthritis and / or peripheral of the Alpes Maritimes and more specifically of the city of Nice and its surroundings. The subjects will be recruited by the hospital doctors (consultations, hospitalization). Patients will benefit from an inclusion visit in order to explain the protocol, sign the study consent and eliminate a possible contraindication to physical activity. Knowing that this is a physical activity adapted to the health of people and their physical abilities.

Eligibility criteria: Inclusion Criteria:

* Presenting a spondyloarthritis according to the criteria of the ASAS (l'Assessment of SpondyloArthritis international Society)
* Benefiting from a stable treatment by biotherapies for at least 3 months

Exclusion Criteria:

* Patient presenting a cardiac pathology should be decompensating
* Patients having a contraindication in the physical activity
* Lung affection making impossible the effort
* Patient already realizing a physical activity supervised in club or with sports coach

Primary outcomes:
measure: Number of pushes brought reported by the patient through a filled auto-questionnaire every week
timeFrame: After 12 weeks
Secondary outcomes:
measure: Moderators of the membership will be estimated thanks to the EMAPS (Scale of Motivation for Physical activity for health purposes) and thanks to the Big five
timeFrame: 12 weeks
measure: The level of commitment in the physical activity will be estimated by the questionnaire GPAQ (Global Physical Activity Questionnaire)
timeFrame: 12 weeks
measure: The function will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)
timeFrame: 12 weeks
measure: The activity of the disease will be estimated by the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
timeFrame: 12 weeks
measure: The activity of the disease will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)
timeFrame: 12 weeks
measure: The activity of the disease will be estimated by the ASQOL (Ankylosing Spondylitis Quality of Life Questionnaire)
timeFrame: 12 weeks
measure: The activity of the disease will be estimated by the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
timeFrame: 24 weeks
measure: The activity of the disease will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)
timeFrame: 24 weeks
measure: The activity of the disease will be estimated by the ASQOL (Ankylosing Spondylitis Quality of Life Questionnaire)
timeFrame: 24 weeks
measure: The activity of the disease will be estimated by the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
timeFrame: 36 weeks
measure: The activity of the disease will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)
timeFrame: 36 weeks
measure: The activity of the disease will be estimated by the ASQOL (Ankylosing Spondylitis Quality of Life Questionnaire)
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
References:
citation: Saraux A, Guillemin F, Guggenbuhl P, Roux CH, Fardellone P, Le Bihan E, Cantagrel A, Chary-Valckenaere I, Euller-Ziegler L, Flipo RM, Juvin R, Behier JM, Fautrel B, Masson C, Coste J. Prevalence of spondyloarthropathies in France: 2001. Ann Rheum Dis. 2005 Oct;64(10):1431-5. doi: 10.1136/ard.2004.029207. Epub 2005 Apr 7.
citation: Passalent LA, Soever LJ, O'Shea FD, Inman RD. Exercise in ankylosing spondylitis: discrepancies between recommendations and reality. J Rheumatol. 2010 Apr;37(4):835-41. doi: 10.3899/jrheum.090655. Epub 2010 Mar 1.
citation: Fongen C, Sveaas SH, Dagfinrud H. Barriers and Facilitators for Being Physically Active in Patients with Ankylosing Spondylitis: A Cross-sectional Comparative Study. Musculoskeletal Care. 2015 Jun;13(2):76-83. doi: 10.1002/msc.1088. Epub 2014 Nov 5.
citation: O'Dwyer T, McGowan E, O'Shea F, Wilson F. Physical Activity and Exercise: Perspectives of Adults With Ankylosing Spondylitis. J Phys Act Health. 2016 May;13(5):504-13. doi: 10.1123/jpah.2015-0435. Epub 2015 Oct 28.
citation: Labat G, Hayotte M, Bailly L, Fabre R, Brocq O, Gerus P, Breuil V, Fournier-Mehouas M, Zory R, D'Arripe-Longueville F, Roux CH. Impact of a Wearable Activity Tracker on Disease Flares in Spondyloarthritis: A Randomized Controlled Trial. J Rheumatol. 2022 Oct;49(10):1109-1116. doi: 10.3899/jrheum.220140. Epub 2022 Jun 15.