Physical Training Program in Ankylosing Spondylitis

Not Applicable

Completed

• Conditions: Ankylosing Spondylitis
• Interventions: Other: Personalized physical training program

• Registration Number: NCT02284646
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

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

Detailed Description

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).

Study Timeline

• Study First Submitted: 2014-11-03
• Study First Submitted QC: 2014-11-05
• Study First Posted: 2014-11-06
• Study Start: 2014-11-25
• Primary Completion: 2018-10-24
• Study Completion: 2019-11-30
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-24
• Last Update Posted: 2020-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Personalized physical training	Personalized physical training program	9-week personalized physical training program (ergometric bicycle)

Primary Outcome Measures

Name	Time	Method
Percentage of patients reaching an ASAS 20 response	Week 12

Secondary Outcome Measures

Name	Time	Method
Percentage of patients reaching an ASAS 20 response	Week 24

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Toulouse, France