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.

Study Overview

• Status: Completed
• Conditions: Spondylitis, Ankylosing
• Intervention / Treatment: Other: Exercise and Education; Other: Exercise and Education

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.

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Phase 3

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland
    • Mater Misericordiae University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Low 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.; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bath Ankylosing Spondylitis Metrology Index (BASMI)	Pre-intervention, post-intervention and 4-week follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Bath Ankylosing Spondylitis Functional Index (BASFI)	Pre-intervention, post intervention and 4-week follow-up
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	Pre-intervention, post-intervention and 4-week follow-up.
Semi-structured interview	Post-intervention

Collaborators and Investigators

• Sponsor: University College Dublin
• Investigators: Principal Investigator: Anne-Marie Keown, BSc MSc, Mater Misericordiae University Hospital; Principal Investigator: Tara Cusack, PhD, University College Dublin

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: October 1, 2008
• First Submitted That Met QC Criteria: October 1, 2008
• First Posted (Estimate): October 2, 2008

Study Record Updates

• Last Update Posted (Estimate): September 29, 2009
• Last Update Submitted That Met QC Criteria: September 28, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Exercise; Education; Physical Therapy Modalities; Hydrotherapy
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: SS/2008/83; 1/378/1173