Study Results
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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COMPLETED
NA
56 participants
INTERVENTIONAL
2014-11-25
2019-11-30
Brief Summary
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Detailed Description
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The aim of the present study is to assess the efficacy of a physical training program in patients with AS.
Patients will be randomized in two parallel arms: program of personalized physical training (intervention group \[PEPc\]) or program of information about physical activity (control group \[PIAP\]).
Patients will be evaluated at 12 and 24 weeks on activity, functional and metrological scores (ASAS 20, ASAS 5/6, ASDAS, BASDAI, BASFI, BASMI); biological inflammation (CRP); NSAID use and pain VAS.
Primary outcome: percentage of patients reaching an ASAS 20 response at 12 weeks.
Secondary outcomes: ASAS 20 at 24 weeks, ASAS5/6, ASDAS, BASDAI, BASFI, BASMI, CRP, NSAID use and pain VAS at 12 and 24 weeks.
Statistical analysis: comparison of the percentage of patients reaching an ASAS 20 response at 12 weeks in each arm using a Fisher's exact test (main outcome).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Personalized physical training
9-week personalized physical training program (ergometric bicycle)
Personalized physical training program
9-week personalized physical training program (ergometric bicycle)
Information about physical activity
2 sessions of information on physical activity
No interventions assigned to this group
Interventions
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Personalized physical training program
9-week personalized physical training program (ergometric bicycle)
Eligibility Criteria
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Inclusion Criteria
* treated or not with NSAID,
* synthetic DMARD or anti-TNF agent.
Exclusion Criteria
18 Years
60 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Arnaud constantin, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
UH Toulouse
Locations
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University Hospital
Toulouse, , France
Countries
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References
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Pecourneau V, Degboe Y, Barnetche T, Cantagrel A, Constantin A, Ruyssen-Witrand A. Effectiveness of Exercise Programs in Ankylosing Spondylitis: A Meta-Analysis of Randomized Controlled Trials. Arch Phys Med Rehabil. 2018 Feb;99(2):383-389.e1. doi: 10.1016/j.apmr.2017.07.015. Epub 2017 Aug 30.
Other Identifiers
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13 7027 08
Identifier Type: -
Identifier Source: org_study_id
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