Increasing Physical Activity in Ankylosing Spondylitis: a Randomised Controlled Trial

NCT02374502 | Completed

• 1 other identifier: REC2015/01/02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Ankylosing spondylitis is a chronic inflammatory condition that mostly affects the spine. This results in back pain and stiffness, and causes difficulty with daily activities. Physical activity and exercise are key components of the management of ankylosing spondylitis, however many adults with ankylosing spondylitis do not meet physical activity recommendations. This study aims to investigate the effects of a twelve week intervention designed to increase physical activity and exercise in adults with ankylosing spondylitis.

Conditions

Spondylitis, Ankylosing

Keywords

Spondylarthropathies; Motor Activity; Physical Therapists; Accelerometry

Outcome Measures

Primary Outcomes (1)

• Free-living Physical Activity

  Actigraph monitor GT3X-BT worn during waking hours over 7 days.

  up to 12 weeks follow-up

Secondary Outcomes (10)

• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  up to 12 weeks follow-up

• Bath Ankylosing Spondylitis Functional Index (BASFI)

  up to 12 weeks follow-up

• Bath Ankylosing Spondylitis Global score (BAS-G)

  up to 12 weeks follow-up

• Ankylosing Spondylitis Quality of Life questionnaire (ASQoL)

  up to 12 weeks follow-up

• Cardiorespiratory capacity

  up to 12 weeks follow-up

Study Arms (2)

Brief Intervention Group

EXPERIMENTAL

Participants in this intervention group will receive a twelve week 'Brief Intervention' delivered by a physiotherapist. Participants will have an initial consultation with a physiotherapist, followed by a number of follow-up sessions. The number and timing of follow-up sessions will be at the participant's discretion (a minimum of 3 and a maximum of 11 over the duration of the study). The follow-up sessions can be face-to-face, over the telephone, or video conferencing depending on participant preference. Participants may additionally opt-in for a weekly email or text message reminder of physical activity goals.

Behavioral: Brief Intervention

Control Group

NO INTERVENTION

Participants in this control group will be asked to continue with their current levels of physical activity.

Interventions

Brief Intervention BEHAVIORAL

'Brief Intervention' is the term used to mean verbal advice, discussion, negotiation or encouragement, with or without written or other support or follow-up. 'Brief Interventions' provide a structured way to deliver advice and involve the provision of formal help and follow-up. They aim to equip people with tools to change attitudes and handle underlying problems.

Brief Intervention Group

Eligibility Criteria

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

You may qualify if:

• Diagnosis of ankylosing spondylitis (diagnosed by a rheumatologist).
• Able to read and understand the English language.
• On stable pharmacological management.

You may not qualify if:

• Under 18 years of age, or over 64 years of age
• Unable to read and understand the English language
• Concomitant cardiac, respiratory or neurological condition
• Co-morbidity restricting physical activity or inability to ambulate without a mobility aid
• Acute lower limb injury
• Uncontrolled epilepsy
• Cognitive difficulties limiting ability to follow safety and protocol instructions
• Pregnant
• Change in medication (type of dosage) within six weeks of testing
• On beta-blocker medication.

Sponsors & Collaborators

• University of Dublin, Trinity College: lead

Study Sites (1)

Trinity Centre for Health Sciences

Dublin, D8, Ireland

Location

Related Publications (1)

• O'Dwyer T, Monaghan A, Moran J, O'Shea F, Wilson F. Behaviour change intervention increases physical activity, spinal mobility and quality of life in adults with ankylosing spondylitis: a randomised trial. J Physiother. 2017 Jan;63(1):30-39. doi: 10.1016/j.jphys.2016.11.009. Epub 2016 Dec 8.

  PMID: 27989730 DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing; Spondylarthropathies; Motor Activity

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Finbar O'Shea

  St. James's Hospital, Ireland

  PRINCIPAL INVESTIGATOR

• Fiona Wilson

  University of Dublin, Trinity College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead Investigator

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: February 27, 2015
• Study Start: March 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 9, 2016

Record last verified: 2016-03

Locations

IE (1)