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

This study has been completed.
Sponsor:
Information provided by:
University College Dublin
ClinicalTrials.gov Identifier:
NCT00764686
First received: October 1, 2008
Last updated: September 28, 2009
Last verified: September 2009

October 1, 2008
September 28, 2009
June 2008
October 2008   (final data collection date for primary outcome measure)
Bath Ankylosing Spondylitis Metrology Index (BASMI) [ Time Frame: Pre-intervention, post-intervention and 4-week follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00764686 on ClinicalTrials.gov Archive Site
  • Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: Pre-intervention, post intervention and 4-week follow-up ] [ Designated as safety issue: No ]
  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: Pre-intervention, post-intervention and 4-week follow-up. ] [ Designated as safety issue: No ]
  • Semi-structured interview [ Time Frame: Post-intervention ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Spondylitis, Ankylosing
  • Other: Exercise and Education
    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.
  • Other: Exercise and Education
    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: 1
    Low disease severity group
    Intervention: Other: Exercise and Education
  • Experimental: 2
    Higher disease severity group
    Intervention: Other: Exercise and Education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
January 2009
October 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Ireland
 
NCT00764686
SS/2008/83, 1/378/1173
Yes
Ms Anne-Marie Keown, Physiotherapy Manager, Mater Misericordiae University Hospital, Eccles Street, Dublin 7, Ireland
University College Dublin
Not Provided
Principal Investigator: Anne-Marie Keown, BSc MSc Mater Misericordiae University Hospital
Principal Investigator: Tara Cusack, PhD University College Dublin
University College Dublin
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP