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

NCT ID: NCT03458026

Last Updated: 2018-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-31

Study Completion Date

2022-03-31

Brief Summary

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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

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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

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Spondyloarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Watch connected used and receipt of SMS (text messages)

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.

Group Type OTHER

Without connected object

Intervention Type OTHER

Any intervention except follow-up visit

Interventions

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

Watch connected used and receipt of SMS (text messages)

Intervention Type OTHER

Without connected object

Any intervention except follow-up visit

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LAMHNESS

UNKNOWN

Sponsor Role collaborator

Azur sante

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Nice

Nice, , France

Site Status

Countries

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France

Central Contacts

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Christian ROUX, Pr

Role: CONTACT

04 92 03 54 91

Sabia ACHIOU

Role: CONTACT

04 92 03 54 91

Facility Contacts

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Christian ROUX, Pr

Role: primary

04 92 03 54 91

References

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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.

Reference Type BACKGROUND
PMID: 15817661 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20194443 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25370164 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26529384 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35705234 (View on PubMed)

Other Identifiers

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17-PP-12

Identifier Type: -

Identifier Source: org_study_id

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