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

NCT ID: NCT00764686

Last Updated: 2009-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2009-01-31

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.

Conditions

Spondylitis, Ankylosing

Keywords

Exercise; Education; Hydrotherapy; Physical Therapy Modalities

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Low disease severity group

Group Type: EXPERIMENTAL

Exercise and Education

Intervention Type: OTHER

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.

2

Higher disease severity group

Group Type: EXPERIMENTAL

Exercise and Education

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College Dublin

OTHER

Sponsor Role: lead

Responsible Party

Mater Misericordiae University Hospital, Eccles Street, Dublin 7, Ireland

Principal Investigators

Anne-Marie Keown, BSc MSc

Role: PRINCIPAL_INVESTIGATOR

Mater Misericordiae University Hospital

Tara Cusack, PhD

Role: PRINCIPAL_INVESTIGATOR

University College Dublin

Locations

Mater Misericordiae University Hospital

Dublin, , Ireland

Countries

Ireland

Other Identifiers

1/378/1173

Identifier Type: -

Identifier Source: secondary_id

SS/2008/83

Identifier Type: -

Identifier Source: org_study_id