Move Your Spondyl " Better Live Its Rheumatism With the Physical Activity "

Spondyloarthritis Clinical Trial

Official title:

Move Your Spondyl " Better Live Its Rheumatism With the Physical Activity "

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03458026
• Other study ID #: 17-PP-12
• Status: Not yet recruiting
• Phase: N/A
• First received: February 23, 2018
• Last updated: March 8, 2018
• Start date: March 2018
• Est. completion date: March 2022

Study information

• Verified date: February 2018
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Christian ROUX, Pr
• Phone: 04 92 03 54 91
• Email: roux.c2[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rheumatic Diseases
• Spondylarthritis
• Spondyloarthritis

Intervention

Other:
• Connected object use combined with SMS (text messages) of physical activity reminders
Watch connected used and receipt of SMS (text messages)
• Without connected object
Any intervention except follow-up visit

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice	Azur sante, LAMHNESS

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View 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. — View 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. — View 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. Epub 2005 Apr 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of pushes brought reported by the patient through a filled auto-questionnaire every week	This questionnaire containing 3 items: did you present a push of your disease since the last filling of the questionnaire?,not, yes during 1 in 3 in the daytime,yes more than 3 days	After 12 weeks
Secondary	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	the EMAPS questionnaire will allow to quantify by the motivation of the patients to practice a physical activity.; this questionnaire is specifically for health purposes.	12 weeks
Secondary	The level of commitment in the physical activity will be estimated by the questionnaire GPAQ (Global Physical Activity Questionnaire)	the qestionnaire GPAQ is a scale to quantify overall physical activity (based on physical activity at work and in the home).	12 weeks
Secondary	The function will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)		12 weeks
Secondary	The activity of the disease will be estimated by the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)		12 weeks
Secondary	The activity of the disease will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)		12 weeks
Secondary	The activity of the disease will be estimated by the ASQOL (Ankylosing Spondylitis Quality of Life Questionnaire)	the ASQOL questionnaire is a quality of life scale. this questionnaire is specifically designed for patients with spondyloarthritis.	12 weeks
Secondary	The activity of the disease will be estimated by the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)		24 weeks
Secondary	The activity of the disease will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)		24 weeks
Secondary	The activity of the disease will be estimated by the ASQOL (Ankylosing Spondylitis Quality of Life Questionnaire)	the ASQOL questionnaire is a quality of life scale. this questionnaire is specifically designed for patients with spondyloarthritis.	24 weeks
Secondary	The activity of the disease will be estimated by the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)		36 weeks
Secondary	The activity of the disease will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)		36 weeks
Secondary	The activity of the disease will be estimated by the ASQOL (Ankylosing Spondylitis Quality of Life Questionnaire)	the ASQOL questionnaire is a quality of life scale. this questionnaire is specifically designed for patients with spondyloarthritis.	36 weeks