A Study Investigating an Exercise and Education Programme for Individuals With Ankylosing Spondylitis

Phase 3

Completed

• Conditions: Spondylitis, Ankylosing
• Interventions: Other: Exercise and Education

• Registration Number: NCT00764686
• Lead Sponsor: University College Dublin

Brief Summary

Ankylosing Spondylitis(AS) is a chronic, inflammatory, rheumatic disease (Khan, 2002). AS is associated with increased work disability and use of healthcare resources (Ward et al, 2008). Evidence suggests that group exercise is the most effective form of physiotherapy management for individuals with Ankylosing Spondylitis (Dagfinrud et al, 2008). To date, no research has been published in relation to short, intensive group exercise programmes.

This study aims to investigate the effects of a five day exercise and education programme for individuals with Ankylosing Spondylitis. Effects of the programme on disease activity, function and spinal mobility will be measured using using validated quantitative measures; the overall value of the programme for patients will be explored by means of semi-structured interviews.

Detailed Description

Patients with a diagnosis of Ankylosing Spondylitis are referred to the 5-day exercise and education programme by consultant rheumatologists at the Mater Misericordiae University Hospital. All patients referred to the programmes beginning 06/24/2008 and 08/25/2008 will be invited to participate.

Participants scoring 0-6 on the Bath Ankylosing Spondylitis Metrology Index are classified as low disease severity level and are allocated to Group 1; participants with a score of 6.1-10 are classified as higher disease severity and allocated to Group 2. Group 1 has two hydrotherapy classes, a gym-based exercise class and an education session daily. Group 2 has one hydrotherapy class, a gym-based exercise class and an education session daily. Exercise sessions are 1 hour in duration and are given by staff physiotherapists. Education sessions are 1 hour in duration and are given by senior members of the rheumatology multi-disciplinary team at the Mater Misericordiae University Hospital.

Outcome will be assessed upon entry to the study (pre-intervention), at 5 days (post-intervention) and at 4 weeks (follow-up). A semi structured interview will be carried out with each participant immediately post-intervention to explore the overall value of the group programme for participants.

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2008-10
• Study First Submitted: 2008-10-01
• Study First Submitted QC: 2008-10-01
• Study First Posted: 2008-10-02
• Study Completion: 2009-01
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-28
• Last Update Posted: 2009-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• A diagnosis of Ankylosing Spondylitis according to the modified New York criteria

Exclusion Criteria

• Patients for whom hydrotherapy or land-exercise have been contra-indicated
• Cognitive Impairment
• Patients unwilling to give informed, written consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Exercise and Education	Low disease severity group
2	Exercise and Education	Higher disease severity group

Primary Outcome Measures

Name	Time	Method
Bath Ankylosing Spondylitis Metrology Index (BASMI)	Pre-intervention, post-intervention and 4-week follow-up

Secondary Outcome Measures

Name	Time	Method
Bath Ankylosing Spondylitis Functional Index (BASFI)	Pre-intervention, post intervention and 4-week follow-up
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	Pre-intervention, post-intervention and 4-week follow-up.
Semi-structured interview	Post-intervention

Trial Locations

Locations (1)

Mater Misericordiae University Hospital; 🇮🇪 Dublin, Ireland