A Study Investigating an Exercise and Education Programme for Individuals With Ankylosing Spondylitis
Primary Purpose
Spondylitis, Ankylosing
Status
Completed
Phase
Phase 3
Locations
Ireland
Study Type
Interventional
Intervention
Exercise and Education
Exercise and Education
Sponsored by
About this trial
This is an interventional treatment trial for Spondylitis, Ankylosing focused on measuring Exercise, Education, Hydrotherapy, Physical Therapy Modalities
Eligibility Criteria
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
Sites / Locations
- Mater Misericordiae University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Low disease severity group
Higher disease severity group
Outcomes
Primary Outcome Measures
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Secondary Outcome Measures
Bath Ankylosing Spondylitis Functional Index (BASFI)
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Semi-structured interview
Full Information
NCT ID
NCT00764686
First Posted
October 1, 2008
Last Updated
September 28, 2009
Sponsor
University College Dublin
1. Study Identification
Unique Protocol Identification Number
NCT00764686
Brief Title
A Study Investigating an Exercise and Education Programme for Individuals With Ankylosing Spondylitis
Official Title
A Study Investigating an Exercise and Education Programme for Individuals With Ankylosing Spondylitis.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University College Dublin
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondylitis, Ankylosing
Keywords
Exercise, Education, Hydrotherapy, Physical Therapy Modalities
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Low disease severity group
Arm Title
2
Arm Type
Experimental
Arm Description
Higher disease severity group
Intervention Type
Other
Intervention Name(s)
Exercise and Education
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise and Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time Frame
Pre-intervention, post-intervention and 4-week follow-up
Secondary Outcome Measure Information:
Title
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time Frame
Pre-intervention, post intervention and 4-week follow-up
Title
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame
Pre-intervention, post-intervention and 4-week follow-up.
Title
Semi-structured interview
Time Frame
Post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Marie Keown, BSc MSc
Organizational Affiliation
Mater Misericordiae University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tara Cusack, PhD
Organizational Affiliation
University College Dublin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mater Misericordiae University Hospital
City
Dublin
Country
Ireland
12. IPD Sharing Statement
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A Study Investigating an Exercise and Education Programme for Individuals With Ankylosing Spondylitis
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