Physical Training Program in Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

— PEPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02284646
• Other study ID #: 13 7027 08
• Status: Completed
• Phase: N/A
• Start date: November 25, 2014
• Est. completion date: November 30, 2019

Study information

• Verified date: August 2020
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 30, 2019
• Est. primary completion date: October 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Other:
• Personalized physical training program
9-week personalized physical training program (ergometric bicycle)

Locations

Country	Name	City	State
France	University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients reaching an ASAS 20 response		Week 12
Secondary	Percentage of patients reaching an ASAS 20 response		Week 24