Increasing Physical Activity in Ankylosing Spondylitis: a Randomised Controlled Trial

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Spondylitis, Ankylosing

Intervention / Treatment
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* Behavioral: Brief Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief Intervention Group<br>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<br>* '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.<br>|
| No Intervention: Control Group<br>Participants in this control group will be asked to continue with their current levels of physical activity. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Free-living Physical Activity | Actigraph monitor GT3X-BT worn during waking hours over 7 days. | up to 12 weeks follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | VO2peak measured by submaximal, incremental treadmill test | up to 12 weeks follow-up | 
| Body Composition | Bioelectric impedance analysis & waist/hip circumference | up to 12 weeks follow-up | 
| Flexibility | Bath Ankylosing Spondylitis Metrology Index (BASMI) & Chest Expansion | up to 12 weeks follow-up | 
| Muscular fitness | Push-up test and curl-up test | up to 12 weeks follow-up | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spondylarthropathies, Motor Activity, Physical Therapists, Accelerometry