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

Spondylitis, Ankylosing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00764686
• Other study ID #: SS/2008/83
• Secondary ID: 1/378/1173
• Status: Completed
• Phase: Phase 3
• First received: October 1, 2008
• Last updated: September 28, 2009
• Start date: June 2008
• Est. completion date: January 2009

Study information

• Verified date: September 2009
• Source: University College Dublin
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Medical Ethics Research Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spondylitis
• Spondylitis, Ankylosing

Intervention

Other:
• Exercise and Education
One hydrotherapy class, one land-exercise class and one education session daily, for five days. Each exercise class and education session is one hour in duration.
• Exercise and Education
Two hydrotherapy classes, one land-exercise class and one education session daily, for five days. Each exercise class and education are one hour in duration.

Locations

Country	Name	City	State
Ireland	Mater Misericordiae University Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
University College Dublin

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bath Ankylosing Spondylitis Metrology Index (BASMI)		Pre-intervention, post-intervention and 4-week follow-up	No
Secondary	Bath Ankylosing Spondylitis Functional Index (BASFI)		Pre-intervention, post intervention and 4-week follow-up	No
Secondary	Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)		Pre-intervention, post-intervention and 4-week follow-up.	No
Secondary	Semi-structured interview		Post-intervention	No