SpondyloarthritisNCT03458026
Move Your Spondyl " Better Live Its Rheumatism With the Physical Activity "
A study testing Connected object use combined with SMS (text messages) of physical activity reminders and Without connected object in people with Spondyloarthritis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondyloarthritis
- What is being tested?
- Connected object use combined with SMS (text messages) of physical activity reminders and Without connected object
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteFrance
- Study dates
- 22 Mar 2018to 26 Mar 2019
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Spondyloarthritis
- Being tested
- Connected object use combined with SMS (text messages) of physical activity reminders, Without connected object
- Keywords
- activity, Connected object
- Medical subject headings
- Spondylarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connected object use combined with SMS (text messages) of physical activity remindersOther
Watch connected used and receipt of SMS (text messages)
Without connected objectOther
Any intervention except follow-up visit
| Study group | Role | What they receive |
|---|---|---|
| connected object + SMS of physical activity reminders | Experimental | 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. Receives: Other: Connected object use combined with SMS (text messages) of physical activity reminders |
| Without connected object | Other | 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. Receives: Other: Without connected object |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After 12 weeks
Secondary outcomes (12)
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.
Measured: 12 weeks
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).
Measured: 12 weeks
The function will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)
Measured: 12 weeks
The activity of the disease will be estimated by the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
Measured: 12 weeks
The activity of the disease will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)
Measured: 12 weeks
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.
Measured: 12 weeks
The activity of the disease will be estimated by the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
Measured: 24 weeks
The activity of the disease will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)
Measured: 24 weeks
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.
Measured: 24 weeks
The activity of the disease will be estimated by the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
Measured: 36 weeks
The activity of the disease will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)
Measured: 36 weeks
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.
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start22 Mar 2018
- Primary completion1 Mar 2019
- Study completion26 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Collaborators
- LAMHNESS, Azur sante
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458026
- Sponsor's protocol ID
- 17-PP-12
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2018
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 15817661Passalent 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 20194443Fongen 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 25370164O'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 26529384Labat 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Move Your Spondyl " Better Live Its Rheumatism With the Physical Activity "
- ClinicalTrials.gov ID
- NCT03458026
- Acronym / sponsor ID
- 17-PP-12
- Conditions
- Spondyloarthritis
- Keywords
- activity, Connected object
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Collaborators
- LAMHNESS, Azur sante
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 8 Mar 2018 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| connected object + SMS of physical activity reminders | Experimental | Other: Connected object use combined with SMS (text messages) of physical activity remindersThe 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. |
| Without connected object | Other | Other: Without connected objectThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Connected object use combined with SMS (text messages) of physical activity remindersWatch connected used and receipt of SMS (text messages) | Other | connected object + SMS of physical activity reminders |
| Without connected objectAny intervention except follow-up visit | Other | Without connected object |
Primary outcome
Number of pushes brought reported by the patient through a filled auto-questionnaire every week
Time frame: After 12 weeks
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
12 secondary outcomes
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
Time frame: 12 weeks
The level of commitment in the physical activity will be estimated by the questionnaire GPAQ (Global Physical Activity Questionnaire)
Time frame: 12 weeks
The function will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)
Time frame: 12 weeks
The activity of the disease will be estimated by the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
Time frame: 12 weeks
The activity of the disease will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)
Time frame: 12 weeks
The activity of the disease will be estimated by the ASQOL (Ankylosing Spondylitis Quality of Life Questionnaire)
Time frame: 12 weeks
The activity of the disease will be estimated by the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
Time frame: 24 weeks
The activity of the disease will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)
Time frame: 24 weeks
The activity of the disease will be estimated by the ASQOL (Ankylosing Spondylitis Quality of Life Questionnaire)
Time frame: 24 weeks
The activity of the disease will be estimated by the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
Time frame: 36 weeks
The activity of the disease will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)
Time frame: 36 weeks
The activity of the disease will be estimated by the ASQOL (Ankylosing Spondylitis Quality of Life Questionnaire)
Time frame: 36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Background: PubMed 15817661Saraux 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.
- Background: PubMed 20194443Passalent 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.
- Background: PubMed 25370164Fongen 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.
- Background: PubMed 26529384O'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.
- Results publication: PubMed 35705234Labat 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connected object use combined with SMS (text messages) of physical activity reminders and Without connected object in people with Spondyloarthritis, run by Centre Hospitalier Universitaire de Nice 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 24 Mar 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of pushes brought reported by the patient through a filled auto-questionnaire every week (time frame: After 12 weeks). 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 NCT03458026, which also lists 5 linked publications.
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 24 Mar 2026.