Increasing Physical Activity in Ankylosing Spondylitis: a Randomised Controlled Trial

NCT ID: NCT02374502

Last Updated: 2016-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-11-30

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.

Detailed Description

Participants will be randomly allocated to one of two groups. An intervention group will receive individual consultations with a physiotherapist. The aim of the meetings will be to motivate and support participants on an individual basis, with the goal of increasing weekly physical activity. The second group, the control group, will continue with their current management strategies. All participants will be assessed at baseline, post-intervention (after twelve weeks) and after a three month follow-up period. The primary outcome measure will be free-living physical activity over one week.

Conditions

Spondylitis, Ankylosing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Brief Intervention Group

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.

Group Type: EXPERIMENTAL

Brief Intervention

Intervention Type: 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.

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Brief Intervention

'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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Dublin, Trinity College

OTHER

Sponsor Role: lead

Responsible Party

Tom O'Dwyer

Lead Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Finbar O'Shea

Role: PRINCIPAL_INVESTIGATOR

St. James's Hospital, Ireland

Fiona Wilson

Role: PRINCIPAL_INVESTIGATOR

University of Dublin, Trinity College

Locations

Trinity Centre for Health Sciences

Dublin, , Ireland

Countries

Ireland

References

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.

Reference Type: DERIVED

PMID: 27989730 (View on PubMed)

Other Identifiers

REC2015/01/02

Identifier Type: -

Identifier Source: org_study_id