NCT02284646

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 6, 2014

Completed
19 days until next milestone

Study Start

First participant enrolled

November 25, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

December 5, 2025

Status Verified

August 1, 2020

Enrollment Period

3.9 years

First QC Date

November 3, 2014

Last Update Submit

November 27, 2025

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing spondylitisPhysical training program

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients reaching an ASAS 20 response

    Week 12

Secondary Outcomes (1)

  • Percentage of patients reaching an ASAS 20 response

    Week 24

Study Arms (2)

Personalized physical training

EXPERIMENTAL

9-week personalized physical training program (ergometric bicycle)

Other: Personalized physical training program

Information about physical activity

NO INTERVENTION

2 sessions of information on physical activity

Interventions

Personalized physical training programOTHER

9-week personalized physical training program (ergometric bicycle)

Personalized physical training

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with AS according to ASAS criteria,
  • treated or not with NSAID,
  • synthetic DMARD or anti-TNF agent.

You may not qualify if:

  • Contraindications to physical training program (e.g. cardiac failure, pregnancy, painful arthroplasty or lower limbs damaged joint).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Toulouse, 31000, France

Location

Related Publications (1)

  • Pecourneau V, Degboe Y, Barnetche T, Cantagrel A, Constantin A, Ruyssen-Witrand A. Effectiveness of Exercise Programs in Ankylosing Spondylitis: A Meta-Analysis of Randomized Controlled Trials. Arch Phys Med Rehabil. 2018 Feb;99(2):383-389.e1. doi: 10.1016/j.apmr.2017.07.015. Epub 2017 Aug 30.

    PMID: 28860095RESULT

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Study Officials

  • Arnaud constantin, MD, PHD

    UH Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2014

First Posted

November 6, 2014

Study Start

November 25, 2014

Primary Completion

October 24, 2018

Study Completion

November 30, 2019

Last Updated

December 5, 2025

Record last verified: 2020-08

Locations

FR(1)