Increasing Physical Activity in Ankylosing Spondylitis: a Randomised Controlled Trial

Not Applicable

Completed

• Conditions: Spondylitis, Ankylosing
• Interventions: Behavioral: Brief Intervention

• Registration Number: NCT02374502
• Lead Sponsor: University of Dublin, Trinity College

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.

Study Timeline

• Study First Submitted: 2015-02-23
• Study First Submitted QC: 2015-02-26
• Study First Posted: 2015-02-27
• Study Start: 2015-03
• Primary Completion: 2015-10
• Study Completion: 2015-11
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-08
• Last Update Posted: 2016-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brief Intervention Group	Brief Intervention	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.

Primary Outcome Measures

Name	Time	Method
Free-living Physical Activity	up to 12 weeks follow-up	Actigraph monitor GT3X-BT worn during waking hours over 7 days.

Secondary Outcome Measures

Name	Time	Method
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	up to 12 weeks follow-up
Flexibility	up to 12 weeks follow-up	Bath Ankylosing Spondylitis Metrology Index (BASMI) \& Chest Expansion
Body Composition	up to 12 weeks follow-up	Bioelectric impedance analysis \& waist/hip circumference
Muscular fitness	up to 12 weeks follow-up	Push-up test and curl-up test
Exercise Barriers and Beliefs Scale (EBBS)	up to 12 weeks follow-up
Arthritis self-efficacy questionnaire (Ankylosing Spondylitis version)	up to 12 weeks follow-up
Bath Ankylosing Spondylitis Functional Index (BASFI)	up to 12 weeks follow-up
Ankylosing Spondylitis Quality of Life questionnaire (ASQoL)	up to 12 weeks follow-up
Bath Ankylosing Spondylitis Global score (BAS-G)	up to 12 weeks follow-up
Cardiorespiratory capacity	up to 12 weeks follow-up	VO2peak measured by submaximal, incremental treadmill test

Trial Locations

Locations (1)

Trinity Centre for Health Sciences; 🇮🇪 Dublin, Ireland