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NCT Number: NCT00764686

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.

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Key information

Conditions

Spondylitis, Ankylosing Ankylosis Arthritis Axial Spondyloarthritis Behavior Bone Diseases Joint Diseases Motor Activity Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mater Misericordiae University Hospital

Dublin, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise and Education

Other

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.

Primary outcomes

  1. Bath Ankylosing Spondylitis Metrology Index (BASMI)

    Time frame: Pre-intervention, post-intervention and 4-week follow-up

Secondary outcomes

  1. Bath Ankylosing Spondylitis Functional Index (BASFI)

    Time frame: Pre-intervention, post intervention and 4-week follow-up

  2. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    Time frame: Pre-intervention, post-intervention and 4-week follow-up.

  3. Semi-structured interview

    Time frame: Post-intervention

Sponsors and collaborators

Lead sponsor

University College Dublin

Other

Registry information

Official study title

A Study Investigating an Exercise and Education Programme for Individuals With Ankylosing Spondylitis.

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Oct 2, 2008
Registry last updated
Sep 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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