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

NCT00764686 | Completed Phase 3 DMC

• 2 other identifiers: SS/2008/831/378/1173
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Spondylitis, Ankylosing

Keywords

Exercise; Education; Hydrotherapy; Physical Therapy Modalities

Outcome Measures

Primary Outcomes (1)

• Bath Ankylosing Spondylitis Metrology Index (BASMI)

  Pre-intervention, post-intervention and 4-week follow-up

Secondary Outcomes (3)

• 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

Study Arms (2)

1

EXPERIMENTAL

Low disease severity group

Other: Exercise and Education

2

EXPERIMENTAL

Higher disease severity group

Other: Exercise and Education

Interventions

Exercise and Education 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.

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of Ankylosing Spondylitis according to the modified New York criteria

You may not qualify if:

• Patients for whom hydrotherapy or land-exercise have been contra-indicated
• Cognitive Impairment
• Patients unwilling to give informed, written consent

Sponsors & Collaborators

• University College Dublin: lead

Study Sites (1)

Mater Misericordiae University Hospital

Dublin, Ireland

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing; Motor Activity

Interventions

Exercise; Educational Status

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Socioeconomic Factors; Population Characteristics

Study Officials

• Anne-Marie Keown, BSc MSc

  Mater Misericordiae University Hospital

  PRINCIPAL INVESTIGATOR

• Tara Cusack, PhD

  University College Dublin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 1, 2008
• First Posted: October 2, 2008
• Study Start: June 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: January 1, 2009
• Last Updated: September 29, 2009

Record last verified: 2009-09

Locations

IE (1)