A Study Investigating an Exercise and Education Programme for Individuals With Ankylosing Spondylitis
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|ClinicalTrials.gov Identifier: NCT00764686|
Recruitment Status : Completed
First Posted : October 2, 2008
Last Update Posted : September 29, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Spondylitis, Ankylosing||Other: Exercise and Education||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study Investigating an Exercise and Education Programme for Individuals With Ankylosing Spondylitis.|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||January 2009|
Low disease severity group
Other: 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.
Higher disease severity group
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.
- Bath Ankylosing Spondylitis Metrology Index (BASMI) [ Time Frame: Pre-intervention, post-intervention and 4-week follow-up ]
- Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: Pre-intervention, post intervention and 4-week follow-up ]
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: Pre-intervention, post-intervention and 4-week follow-up. ]
- Semi-structured interview [ Time Frame: Post-intervention ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00764686
|Mater Misericordiae University Hospital|
|Principal Investigator:||Anne-Marie Keown, BSc MSc||Mater Misericordiae University Hospital|
|Principal Investigator:||Tara Cusack, PhD||University College Dublin|