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

March 8, 2018 updated by: Centre Hospitalier Universitaire de Nice
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Watch connected used and receipt of SMS (text messages)
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
Any intervention except follow-up visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
After 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 EMAPS questionnaire will allow to quantify by the motivation of the patients to practice a physical activity.

this questionnaire is specifically for health purposes.
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 qestionnaire GPAQ is a scale to quantify overall physical activity (based on physical activity at work and in the home).
12 weeks
The function will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)
Time Frame: 12 weeks
12 weeks
The activity of the disease will be estimated by the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
Time Frame: 12 weeks
12 weeks
The activity of the disease will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)
Time Frame: 12 weeks
12 weeks
The activity of the disease will be estimated by the ASQOL (Ankylosing Spondylitis Quality of Life Questionnaire)
Time Frame: 12 weeks
the ASQOL questionnaire is a quality of life scale. this questionnaire is specifically designed for patients with spondyloarthritis.
12 weeks
The activity of the disease will be estimated by the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
Time Frame: 24 weeks
24 weeks
The activity of the disease will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)
Time Frame: 24 weeks
24 weeks
The activity of the disease will be estimated by the ASQOL (Ankylosing Spondylitis Quality of Life Questionnaire)
Time Frame: 24 weeks
the ASQOL questionnaire is a quality of life scale. this questionnaire is specifically designed for patients with spondyloarthritis.
24 weeks
The activity of the disease will be estimated by the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
Time Frame: 36 weeks
36 weeks
The activity of the disease will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)
Time Frame: 36 weeks
36 weeks
The activity of the disease will be estimated by the ASQOL (Ankylosing Spondylitis Quality of Life Questionnaire)
Time Frame: 36 weeks
the ASQOL questionnaire is a quality of life scale. this questionnaire is specifically designed for patients with spondyloarthritis.
36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Collaborators

LAMHNESS
Azur sante

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2018

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

February 23, 2018

First Submitted That Met QC Criteria

March 1, 2018

First Posted (Actual)

March 8, 2018

Study Record Updates

Last Update Posted (Actual)

March 12, 2018

Last Update Submitted That Met QC Criteria

March 8, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-PP-12

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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