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Increasing Physical Activity in Ankylosing Spondylitis: a Randomised Controlled Trial

Increasing Physical Activity in Ankylosing Spondylitis (INPACT-AS): a Randomised Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02374502
Acronym
INPACT-AS
Enrollment
40
Registered
2015-02-27
Start date
2015-03-31
Completion date
2015-11-30
Last updated
2016-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spondylitis, Ankylosing

Keywords

Spondylarthropathies, Motor Activity, Physical Therapists, Accelerometry

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.

Interventions

BEHAVIORALBrief 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.

Sponsors

University of Dublin, Trinity College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Free-living Physical Activityup to 12 weeks follow-upActigraph monitor GT3X-BT worn during waking hours over 7 days.

Secondary

MeasureTime frameDescription
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 capacityup to 12 weeks follow-upVO2peak measured by submaximal, incremental treadmill test
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)up to 12 weeks follow-up
Flexibilityup to 12 weeks follow-upBath Ankylosing Spondylitis Metrology Index (BASMI) & Chest Expansion
Muscular fitnessup to 12 weeks follow-upPush-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
Body Compositionup to 12 weeks follow-upBioelectric impedance analysis & waist/hip circumference

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026