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

Primary Purpose

Spondyloarthritis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Connected object use combined with SMS (text messages) of physical activity reminders
Without connected object
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spondyloarthritis focused on measuring activity, Connected object

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Nice

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

connected object + SMS of physical activity reminders

Without connected object

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 23, 2018
Last Updated
March 8, 2018
Sponsor
Centre Hospitalier Universitaire de Nice
Collaborators
LAMHNESS, Azur sante
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1. Study Identification

Unique Protocol Identification Number
NCT03458026
Brief Title
Move Your Spondyl " Better Live Its Rheumatism With the Physical Activity "
Official Title
Move Your Spondyl " Better Live Its Rheumatism With the Physical Activity "
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2018 (Anticipated)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
Collaborators
LAMHNESS, Azur sante

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondyloarthritis
Keywords
activity, Connected object

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
connected object + SMS of physical activity reminders
Arm Type
Experimental
Arm Description
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.
Arm Title
Without connected object
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Connected object use combined with SMS (text messages) of physical activity reminders
Intervention Description
Watch connected used and receipt of SMS (text messages)
Intervention Type
Other
Intervention Name(s)
Without connected object
Intervention Description
Any intervention except follow-up visit
Primary Outcome Measure Information:
Title
Number of pushes brought reported by the patient through a filled auto-questionnaire every week
Description
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 Outcome Measure Information:
Title
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
Description
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
Title
The level of commitment in the physical activity will be estimated by the questionnaire GPAQ (Global Physical Activity Questionnaire)
Description
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
Title
The function will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)
Time Frame
12 weeks
Title
The activity of the disease will be estimated by the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
Time Frame
12 weeks
Title
The activity of the disease will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)
Time Frame
12 weeks
Title
The activity of the disease will be estimated by the ASQOL (Ankylosing Spondylitis Quality of Life Questionnaire)
Description
the ASQOL questionnaire is a quality of life scale. this questionnaire is specifically designed for patients with spondyloarthritis.
Time Frame
12 weeks
Title
The activity of the disease will be estimated by the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
Time Frame
24 weeks
Title
The activity of the disease will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)
Time Frame
24 weeks
Title
The activity of the disease will be estimated by the ASQOL (Ankylosing Spondylitis Quality of Life Questionnaire)
Description
the ASQOL questionnaire is a quality of life scale. this questionnaire is specifically designed for patients with spondyloarthritis.
Time Frame
24 weeks
Title
The activity of the disease will be estimated by the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
Time Frame
36 weeks
Title
The activity of the disease will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)
Time Frame
36 weeks
Title
The activity of the disease will be estimated by the ASQOL (Ankylosing Spondylitis Quality of Life Questionnaire)
Description
the ASQOL questionnaire is a quality of life scale. this questionnaire is specifically designed for patients with spondyloarthritis.
Time Frame
36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian ROUX, Pr
Phone
04 92 03 54 91
Email
roux.c2@chu-nice.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sabia ACHIOU
Phone
04 92 03 54 91
Email
achiou.s@chu-nice.fr
Facility Information:
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06003
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian ROUX, Pr
Phone
04 92 03 54 91
Email
roux.c2@chu-nice.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
15817661
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. doi: 10.1136/ard.2004.029207. Epub 2005 Apr 7.
Results Reference
background
PubMed Identifier
20194443
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.
Results Reference
background
PubMed Identifier
25370164
Citation
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.
Results Reference
background
PubMed Identifier
26529384
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.
Results Reference
background
PubMed Identifier
35705234
Citation
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.
Results Reference
derived

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

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