Physical Training Program in Ankylosing Spondylitis

Study Overview
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Brief Summary
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Purpose: to assess the efficacy of a physical training program in patients with ankylosing spondylitis (AS) in a randomized controlled study

Detailed Description
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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).

Official Title
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Assessment of the Efficacy of a Physical Training Program in Patients With Ankylosing Spondylitis

Conditions
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Ankylosing Spondylitis

Intervention / Treatment
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* Other: Personalized physical training program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with AS according to ASAS criteria, treated or not with NSAID, synthetic DMARD or anti-TNF agent. Exclusion Criteria: Contraindications to physical training program (e.g. cardiac failure, pregnancy, painful arthroplasty or lower limbs damaged joint).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalized physical training<br>9-week personalized physical training program (ergometric bicycle) | Other: Personalized physical training program<br>* 9-week personalized physical training program (ergometric bicycle)<br>|
| No Intervention: Information about physical activity<br>2 sessions of information on physical activity | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients reaching an ASAS 20 response |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients reaching an ASAS 20 response |  | Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ankylosing spondylitis, Physical training program