Clinical trial NCT00764686: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spondylitis, Ankylosing
Keywords: Exercise
Education
Hydrotherapy
Physical Therapy Modalities
Lead sponsor: University College Dublin
Sponsor class: OTHER
First posted: 2008-10-02
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Bath Ankylosing Spondylitis Metrology Index (BASMI)
timeFrame: Pre-intervention, post-intervention and 4-week follow-up
Secondary outcomes:
measure: Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: Pre-intervention, post intervention and 4-week follow-up
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Pre-intervention, post-intervention and 4-week follow-up.
measure: Semi-structured interview
timeFrame: Post-intervention
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
Study officials:
affiliation: Mater Misericordiae University Hospital
name: Anne-Marie Keown, BSc MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University College Dublin
name: Tara Cusack, PhD
role: PRINCIPAL_INVESTIGATOR
References: