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| Sponsors and Collaborators: |
University College Dublin Health Research Board, Ireland |
|---|---|
| Information provided by: | University College Dublin |
| ClinicalTrials.gov Identifier: | NCT00764686 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Spondylitis, Ankylosing |
Other: Exercise and Education |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | A Study Investigating an Exercise and Education Programme for Individuals With Ankylosing Spondylitis. |
| Estimated Enrollment: | 18 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | January 2009 |
| Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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.
|
|
2: Experimental
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Tara Cusack, PhD | 00 353 1 7166513 | t.cusack@ucd.ie |
| Contact: Emma Carroll, Undergraduate | 00 353 1 879433224 | emma.carroll2@ucdconnect.ie |
| Ireland | |
| Mater Misericordiae University Hospital | Recruiting |
| Dublin, Ireland | |
| Contact: Breon White, BSc bwhite@mater.ie | |
| Principal Investigator: | Anne-Marie Keown, BSc MSc | Mater Misericordiae University Hospital |
| Principal Investigator: | Tara Cusack, PhD | University College Dublin |
More Information
| Responsible Party: | Mater Misericordiae University Hospital, Eccles Street, Dublin 7, Ireland ( Ms Anne-Marie Keown, Physiotherapy Manager ) |
| Study ID Numbers: | SS/2008/83, 1/378/1173 |
| Study First Received: | October 1, 2008 |
| Last Updated: | October 1, 2008 |
| ClinicalTrials.gov Identifier: | NCT00764686 |
| Health Authority: | Ireland: Medical Ethics Research Committee |
|
Exercise Education Hydrotherapy Physical Therapy Modalities |
|
Spinal Diseases Musculoskeletal Diseases Spondylarthropathy Arthritis Joint Diseases Spondylitis, Ankylosing |
Spondylarthritis Bone Diseases Spondylitis Ankylosis Spondylarthropathies |
|
Infection Bone Diseases, Infectious |
