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
  Purpose

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.


Condition Intervention Phase
Spondylitis, Ankylosing
Other: Exercise and Education
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study Investigating an Exercise and Education Programme for Individuals With Ankylosing Spondylitis.

Resource links provided by NLM:


Further study details as provided by University College Dublin:

Primary Outcome Measures:
  • Bath Ankylosing Spondylitis Metrology Index (BASMI) [ Time Frame: Pre-intervention, post-intervention and 4-week follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 18
Study Start Date: June 2008
Study Completion Date: January 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Low disease severity group
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: 2
Higher disease severity group
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.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00764686

Locations
Ireland
Mater Misericordiae University Hospital
Dublin, Ireland
Sponsors and Collaborators
University College Dublin
Investigators
Principal Investigator: Anne-Marie Keown, BSc MSc Mater Misericordiae University Hospital
Principal Investigator: Tara Cusack, PhD University College Dublin
  More Information

No publications provided

Responsible Party: Ms Anne-Marie Keown, Physiotherapy Manager, Mater Misericordiae University Hospital, Eccles Street, Dublin 7, Ireland
ClinicalTrials.gov Identifier: NCT00764686     History of Changes
Other Study ID Numbers: SS/2008/83, 1/378/1173
Study First Received: October 1, 2008
Last Updated: September 28, 2009
Health Authority: Ireland: Medical Ethics Research Committee

Keywords provided by University College Dublin:
Exercise
Education
Hydrotherapy
Physical Therapy Modalities

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on April 21, 2014