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Physical Training Program in Ankylosing Spondylitis (PEPS)

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ClinicalTrials.gov Identifier: NCT02284646
Recruitment Status : Recruiting
First Posted : November 6, 2014
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Other: Personalized physical training program Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of the Efficacy of a Physical Training Program in Patients With Ankylosing Spondylitis
Study Start Date : November 2014
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : November 2017


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



Primary Outcome Measures :
  1. Percentage of patients reaching an ASAS 20 response [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Percentage of patients reaching an ASAS 20 response [ Time Frame: Week 24 ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02284646


Contacts
Contact: Arnaud Constantin, MD, PHD +33561776976 ext 33 arnaud.constantin@univ-tlse.fr
Contact: Daniel Riviere, MD, PHD +33567771690 ext 33 riviere.d@chu-toulouse.fr

Locations
France
University Hospital Recruiting
Toulouse, France, 31000
Contact: Arnaud Constantin, MD    +33561776976      
Principal Investigator: Arnaud Constantin, MD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Arnaud constantin, MD, PHD UH Toulouse

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02284646     History of Changes
Other Study ID Numbers: 13 7027 08
First Posted: November 6, 2014    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by University Hospital, Toulouse:
Ankylosing spondylitis
Physical training program

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis