NCT03458026

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

March 22, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2019

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

February 23, 2018

Last Update Submit

March 20, 2026

Conditions

Spondyloarthritis

Keywords

activityConnected object

Outcome Measures

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

    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

    12 weeks

  • The level of commitment in the physical activity will be estimated by the questionnaire GPAQ (Global Physical Activity Questionnaire)

    12 weeks

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

    12 weeks

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

    12 weeks

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

    12 weeks

  • +7 more secondary outcomes

Study Arms (2)

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.

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.

Other: Without connected object

Interventions

Without connected objectOTHER

Any intervention except follow-up visit

Without connected object
Connected object use combined with SMS (text messages) of physical activity remindersOTHER

Watch connected used and receipt of SMS (text messages)

connected object + SMS of physical activity reminders

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, France, 06003, France

Location

Related Publications (5)

  • 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

    BACKGROUND

  • 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.

    PMID: 20194443BACKGROUND

  • 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.

    PMID: 25370164BACKGROUND

  • 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.

    PMID: 26529384BACKGROUND

  • 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.

    PMID: 35705234RESULT

MeSH Terms

Conditions

SpondylarthritisMotor Activity

Interventions

Spermine Synthase

Condition Hierarchy (Ancestors)

SpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesBehavior

Intervention Hierarchy (Ancestors)

Alkyl and Aryl TransferasesTransferasesEnzymesEnzymes and Coenzymes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2018

First Posted

March 8, 2018

Study Start

March 22, 2018

Primary Completion

March 1, 2019

Study Completion

March 26, 2019

Last Updated

March 24, 2026

Record last verified: 2026-03

Locations

FR(1)