A Study Investigating an Exercise and Education Programme for Individuals With Ankylosing Spondylitis - Full Text View

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:

Genetics Home Reference related topics: ankylosing spondylitis

MedlinePlus related topics: Ankylosing Spondylitis Exercise and Physical Fitness

U.S. FDA Resources

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 May 19, 2013