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Physical Training Program in Ankylosing Spondylitis (PEPS)

Primary Purpose

Ankylosing Spondylitis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Personalized physical training program
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring Ankylosing spondylitis, Physical training program

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Personalized physical training

Information about physical activity

Arm Description

9-week personalized physical training program (ergometric bicycle)

2 sessions of information on physical activity

Outcomes

Primary Outcome Measures

Percentage of patients reaching an ASAS 20 response

Secondary Outcome Measures

Percentage of patients reaching an ASAS 20 response

Full Information

First Posted
November 3, 2014
Last Updated
August 24, 2020
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT02284646
Brief Title
Physical Training Program in Ankylosing Spondylitis
Acronym
PEPS
Official Title
Assessment of the Efficacy of a Physical Training Program in Patients With Ankylosing Spondylitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
November 25, 2014 (Actual)
Primary Completion Date
October 24, 2018 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
Ankylosing spondylitis, Physical training program

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Personalized physical training
Arm Type
Experimental
Arm Description
9-week personalized physical training program (ergometric bicycle)
Arm Title
Information about physical activity
Arm Type
No Intervention
Arm Description
2 sessions of information on physical activity
Intervention Type
Other
Intervention Name(s)
Personalized physical training program
Intervention Description
9-week personalized physical training program (ergometric bicycle)
Primary Outcome Measure Information:
Title
Percentage of patients reaching an ASAS 20 response
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percentage of patients reaching an ASAS 20 response
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud constantin, MD, PHD
Organizational Affiliation
UH Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Toulouse
ZIP/Postal Code
31000
Country
France

12. IPD Sharing Statement

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Physical Training Program in Ankylosing Spondylitis

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