- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00764686
A Study Investigating an Exercise and Education Programme for Individuals With Ankylosing Spondylitis
A Study Investigating an Exercise and Education Programme for Individuals With Ankylosing Spondylitis.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Dublin, Ireland
- Mater Misericordiae University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Low disease severity group
|
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.
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.
|
Experimental: 2
Higher disease severity group
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time Frame: Pre-intervention, post-intervention and 4-week follow-up
|
Pre-intervention, post-intervention and 4-week follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time Frame: Pre-intervention, post intervention and 4-week follow-up
|
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.
|
Pre-intervention, post-intervention and 4-week follow-up.
|
Semi-structured interview
Time Frame: Post-intervention
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Post-intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne-Marie Keown, BSc MSc, Mater Misericordiae University Hospital
- Principal Investigator: Tara Cusack, PhD, University College Dublin
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SS/2008/83
- 1/378/1173
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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