CClinicalTrials.gg
CompletedNCT03458026Updated Mar 24, 2026

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

An interventional study of Connected object use combined with SMS (text messages) of physical activity reminders and Without connected object in Spondyloarthritis, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-24.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Spondyloarthritis

Keywords

  • activity
  • Connected object
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
108 participants (actual)

Study arms

  • Experimental
    connected object + SMS of physical activity reminders

    The patients will be included during their visit of follow-up and will receive a watch connected. They will have an information meeting for their to explain how step shows it. They will also receive advice to practise an adapted physical activity. During 12 weeks of SMS (text messages) every week to motivate them to realize these exercises. At the end of 12 weeks the connected watch will be deprived of them as well as SMS (text messages). They will have to realize an activity in autonomy during 12 weeks. At the end of the twenty-fourth week, they will get back their watch. They will have in more 1 session with a coach and 2 sessions to be made in autonomy during 12 weeks. In 36 week, they return the watch and finish the study.

    Other: Connected object use combined with SMS (text messages) of physical activity reminders

  • Other
    Without connected object

    The patients will be included during their visit of follow-up.They will have an information to practice suitable activity during 12 weeks At the end of 12 weeks, they realised follow-up. They will have to realize an activity in autonomy during 12 weeks. At the end of the twenty-fourth week, they will have 1 session with a coach and 2 sessions to be made in autonomy during 12 weeks. In 36 week, the study will be finished.

    Other: Without connected object

Interventions

  • OtherConnected object use combined with SMS (text messages) of physical activity reminders

    Watch connected used and receipt of SMS (text messages)

  • OtherWithout connected object

    Any intervention except follow-up visit

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: After 12 weeks

Secondary outcomes

  1. 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.

    Time frame: 12 weeks

  2. 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).

    Time frame: 12 weeks

  3. The function will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)

    Time frame: 12 weeks

  4. The activity of the disease will be estimated by the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)

    Time frame: 12 weeks

  5. The activity of the disease will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)

    Time frame: 12 weeks

  6. 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.

    Time frame: 12 weeks

  7. The activity of the disease will be estimated by the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)

    Time frame: 24 weeks

  8. The activity of the disease will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)

    Time frame: 24 weeks

  9. 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.

    Time frame: 24 weeks

  10. The activity of the disease will be estimated by the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)

    Time frame: 36 weeks

  11. The activity of the disease will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)

    Time frame: 36 weeks

  12. 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.

    Time frame: 36 weeks

06

Study locations

1 site
  • CHU de Nice
    Nice, France 06003, France
07

References and documents

Publications

  • 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. PubMed 15817661 ↗
  • 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. PubMed 20194443 ↗
  • 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. PubMed 25370164 ↗
  • 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. PubMed 26529384 ↗
  • 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. PubMed 35705234 ↗
08

Registry details

Key details

Study ID
NCT03458026
Lead sponsor
Centre Hospitalier Universitaire de Nice
Collaborators
LAMHNESS, Azur sante
Responsible party
Sponsor
First posted
Mar 8, 2018
Start date
Mar 22, 2018
Primary completion
Mar 1, 2019
Completion
Mar 26, 2019
Last update
Mar 24, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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