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Physical Training Program in Ankylosing Spondylitis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02284646
Acronym
PEPS
Enrollment
56
Registered
2014-11-06
Start date
2014-11-25
Completion date
2019-11-30
Last updated
2025-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing spondylitis, Physical training program

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).

Interventions

OTHERPersonalized physical training program

9-week personalized physical training program (ergometric bicycle)

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frame
Percentage of patients reaching an ASAS 20 responseWeek 12

Secondary

MeasureTime frame
Percentage of patients reaching an ASAS 20 responseWeek 24

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026