PEPS: Physical Training Program in Ankylosing Spondylitis

• Sponsor: University Hospital, Toulouse (Other)
• Overall Status: Completed
• CT.gov ID: NCT02284646
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Actual Duration (Months): 60.2
• Patients Per Site Per Month: 0.9

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Ankylosing Spondylitis	Other: Personalized physical training program	N/A

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 Design

• Study Type: Interventional
• Actual 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
• Actual Study Start Date: Nov 25, 2014
• Actual Primary Completion Date: Oct 24, 2018
• Actual Study Completion Date: Nov 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percentage of patients reaching an ASAS 20 response [Week 12]

Secondary Outcome Measures

1. Percentage of patients reaching an ASAS 20 response [Week 24]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	Toulouse		France	31000

Sponsors and Collaborators

• University Hospital, Toulouse

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Toulouse
• ClinicalTrials.gov Identifier: NCT02284646
• Other Study ID Numbers: 13 7027 08
• First Posted: Nov 6, 2014
• Last Update Posted: Aug 26, 2020
• Last Verified: Aug 1, 2020

• Keywords provided by University Hospital, Toulouse: Ankylosing spondylitis; Physical training program
• Additional relevant MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing

Study Results

No Results Posted as of Aug 26, 2020