Ankylosing Spondylitis Clinical Trial
Official title:
Assessment of the Efficacy of a Physical Training Program in Patients With Ankylosing Spondylitis
Purpose: to assess the efficacy of a physical training program in patients with ankylosing spondylitis (AS) in a randomized controlled study
AS is a chronic inflammatory rheumatic disorder affecting spine, peripheral joints and
entheses. Patients undergo pain, stiffness and reduced mobility of spine and joints. Patients
experience limitations in physical activities and reduced quality of life. Some uncontrolled
studies reported benefits of physical activity in patients with AS.
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).
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