Clinical trial NCT02374502: Increasing Physical Activity in Ankylosing Spondylitis: a Randomised Controlled Trial
Official title: Increasing Physical Activity in Ankylosing Spondylitis (INPACT-AS): a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spondylitis, Ankylosing
Keywords: Spondylarthropathies
Motor Activity
Physical Therapists
Accelerometry
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
First posted: 2015-02-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Free-living Physical Activity
timeFrame: up to 12 weeks follow-up
Secondary outcomes:
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: up to 12 weeks follow-up
measure: Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: up to 12 weeks follow-up
measure: Bath Ankylosing Spondylitis Global score (BAS-G)
timeFrame: up to 12 weeks follow-up
measure: Ankylosing Spondylitis Quality of Life questionnaire (ASQoL)
timeFrame: up to 12 weeks follow-up
measure: Cardiorespiratory capacity
timeFrame: up to 12 weeks follow-up
measure: Body Composition
timeFrame: up to 12 weeks follow-up
measure: Flexibility
timeFrame: up to 12 weeks follow-up
measure: Muscular fitness
timeFrame: up to 12 weeks follow-up
measure: Exercise Barriers and Beliefs Scale (EBBS)
timeFrame: up to 12 weeks follow-up
measure: Arthritis self-efficacy questionnaire (Ankylosing Spondylitis version)
timeFrame: up to 12 weeks follow-up
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Trinity Centre for Health Sciences
Study officials:
affiliation: St. James's Hospital, Ireland
name: Finbar O'Shea
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Dublin, Trinity College
name: Fiona Wilson
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.