Spondylitis, AnkylosingPhase 3NCT00764686
A Study Investigating an Exercise and Education Programme for Individuals With Ankylosing Spondylitis
A Phase 3 study testing Exercise and Education in people with Spondylitis, Ankylosing, run by University College Dublin at 1 site in Ireland.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spondylitis, Ankylosing
- What is being tested?
- Exercise and Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteIreland
- Study dates
- Jun 2008to Jan 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of Ankylosing Spondylitis according to the modified New York criteria
Who cannot join
- Patients for whom hydrotherapy or land-exercise have been contra-indicated
- Cognitive Impairment
- Patients unwilling to give informed, written consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Spondylitis, Ankylosing
- Being tested
- Exercise and Education
- Keywords
- Exercise, Education, Hydrotherapy, Physical Therapy Modalities
- Medical subject headings
- Spondylitis, Ankylosing, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and EducationOther
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 EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Low disease severity group Receives: Other: Exercise and Education |
| 2 | Experimental | Higher disease severity group Receives: Other: Exercise and Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Measured: Pre-intervention, post-intervention and 4-week follow-up
Secondary outcomes (3)
Bath Ankylosing Spondylitis Functional Index (BASFI)
Measured: Pre-intervention, post intervention and 4-week follow-up
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Measured: Pre-intervention, post-intervention and 4-week follow-up.
Semi-structured interview
Measured: Post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startJun 2008
- Primary completionOct 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spondylitis, AnkylosingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Investigators
- Anne-Marie Keown, BSc MSc, Principal investigator, Mater Misericordiae University HospitalTara Cusack, PhD, Principal investigator, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764686
- Sponsor's protocol ID
- SS/2008/83
- Other IDs
- 1/378/1173
- Status last verified
- Sep 2009
- First submitted
- 1 Oct 2008
- Last updated
- 29 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Investigating an Exercise and Education Programme for Individuals With Ankylosing Spondylitis.
- ClinicalTrials.gov ID
- NCT00764686
- Acronym / sponsor ID
- SS/2008/83
- Conditions
- Spondylitis, Ankylosing
- Keywords
- Exercise, Education, Hydrotherapy, Physical Therapy Modalities
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 2 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Exercise and EducationLow disease severity group |
| 2 | Experimental | Other: Exercise and EducationHigher disease severity group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A diagnosis of Ankylosing Spondylitis according to the modified New York criteria
Key exclusion criteria (3 listed)
- Patients for whom hydrotherapy or land-exercise have been contra-indicated
- Cognitive Impairment
- Patients unwilling to give informed, written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise and EducationOne 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. | Other | 2 |
| Exercise and EducationTwo hydrotherapy classes, one land-exercise class and one education session daily, for five days. Each exercise class and education are one hour in duration. | Other | 1 |
Primary outcome
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time frame: Pre-intervention, post-intervention and 4-week follow-up
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Marie Keown, BSc MSc principal investigator
Mater Misericordiae University Hospital
Tara Cusack, PhD principal investigator
University College Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exercise and Education in people with Spondylitis, Ankylosing, run by University College Dublin at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bath Ankylosing Spondylitis Metrology Index (BASMI) (time frame: Pre-intervention, post-intervention and 4-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2009.