Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03458026
Recruitment Status : Unknown
Verified February 2018 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Not yet recruiting
First Posted : March 8, 2018
Last Update Posted : March 12, 2018
Sponsor:
Collaborators:
LAMHNESS
Azur sante
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Spondyloarthritis Other: Connected object use combined with SMS (text messages) of physical activity reminders Other: Without connected object Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Move Your Spondyl " Better Live Its Rheumatism With the Physical Activity "
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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)
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


  2. 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).

  3. The function will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index) [ Time Frame: 12 weeks ]
  4. The activity of the disease will be estimated by the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) [ Time Frame: 12 weeks ]
  5. The activity of the disease will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index) [ Time Frame: 12 weeks ]
  6. 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.

  7. The activity of the disease will be estimated by the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) [ Time Frame: 24 weeks ]
  8. The activity of the disease will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index) [ Time Frame: 24 weeks ]
  9. 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.

  10. The activity of the disease will be estimated by the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) [ Time Frame: 36 weeks ]
  11. The activity of the disease will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index) [ Time Frame: 36 weeks ]
  12. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458026


Contacts
Layout table for location contacts
Contact: Christian ROUX, Pr 04 92 03 54 91 roux.c2@chu-nice.fr
Contact: Sabia ACHIOU 04 92 03 54 91 achiou.s@chu-nice.fr

Locations
Layout table for location information
France
CHU de Nice
Nice, France, 06003
Contact: Christian ROUX, Pr    04 92 03 54 91    roux.c2@chu-nice.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
LAMHNESS
Azur sante
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT03458026    
Other Study ID Numbers: 17-PP-12
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: February 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Nice:
activity
Connected object
Additional relevant MeSH terms:
Layout table for MeSH terms
Spondylarthritis
Rheumatic Diseases
Spondylitis
Spinal Diseases
Bone Diseases
 Musculoskeletal Diseases
Arthritis
Joint Diseases
Connective Tissue Diseases