Physical Training Program in Ankylosing Spondylitis (PEPS)

November 27, 2025 updated by: University Hospital, Toulouse

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31000
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients reaching an ASAS 20 response
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients reaching an ASAS 20 response
Time Frame: Week 24
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Arnaud constantin, MD, PHD, UH Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2014

Primary Completion (Actual)

October 24, 2018

Study Completion (Actual)

November 30, 2019

Study Registration Dates

First Submitted

November 3, 2014

First Submitted That Met QC Criteria

November 5, 2014

First Posted (Estimated)

November 6, 2014

Study Record Updates

Last Update Posted (Estimated)

December 5, 2025

Last Update Submitted That Met QC Criteria

November 27, 2025

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13 7027 08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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