Clinical trial NCT05504616: Health Technology to Improve Exercise in axSpA
Official title: Physical Activity in Axial Spondyloarthritis: Development and Implementation of an Evidence-Based Health Technology Approach to Improve Adherence to Recommended Guidelines
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Axial Spondyloarthritis
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Initiative for Outcomes in Rheumatology Care
First posted: 2022-08-17
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Repeated measures randomized control pre-test/post-test design comparing an intervention group with a control group (usual care).
Primary purpose: TREATMENT

Brief summary: Despite the known benefits of physical activity, the majority of Canadians fail to meet recommended guidelines. Patients with axial spondyloarthritis (axSpA) also fail to meet recommended guidelines. Exercise, a critical component of physical activity, is considered the cornerstone of axSpA management. Simple health technologies such as mobile phone messaging and email can be useful tools to increase engagement in regular physical activity among the general public and patients with chronic disease. As such, the aim of this research project is to develop and test a patient-centered strategy that provides education on the importance of physical activity and utilizes existing health technologies (such as smart phone applications) to encourage regular participation in physical activity. The results of this study are expected to demonstrate that patients with axSpA will increase their daily engagement in physical activity, and therefore improve symptoms, function and overall quality of life.


Eligibility criteria: Inclusion Criteria:

* Adults (aged 18 and older) with a diagnosis of axSpA based on ASAS criteria
* Have access to email and a smart phone device (Android or iOS operating systems)
* Enrolled in the SPARCC Research Program
* Passes pre-participation health screen

Exclusion Criteria:

* Non-English speaking
* Not enrolled in the SPARCC Research Program
* Comorbidities or physical impairments that may preclude physical activity (e.g., symptomatic cardiovascular disease; wheelchair bound etc.)

Primary outcomes:
measure: Changes in levels of physical activity as measured by the International Physical Activity Questionnaire-Short Form questionnaire (IPAQ-SF)
timeFrame: Assessed electronically by an e-survey platform at baseline, 3, 6, 9 and 12 weeks in the intervention and control groups.
measure: Changes in exercise behaviour as measured by an adapted Stanford Exercise Behaviours Questionnaire
timeFrame: Assessed electronically by an e-survey platform at baseline, 3, 6, 9 and 12 weeks in the intervention and control groups.
measure: Change in levels of physical activity as measured by Accelerometry
timeFrame: Assessed at baseline and at 12 weeks.
measure: Change in perceived benefits and barriers to exercise as a result of the technology-based intervention strategy as measured by the Exercise Benefits/Barriers Scale (EBBS)
timeFrame: Assessed at baseline and at 12 weeks.
measure: Change in functioning and health as a result of the technology-based intervention strategy as measured by the ASAS Health Index
timeFrame: Assessed at baseline and at 12 weeks.
Secondary outcomes:
measure: Change in disease activity over the course of 12 weeks as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDI) questionnaire
timeFrame: From baseline, assessed up to 12 weeks.
measure: Change in function over the course of 12 weeks as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) questionnaire
timeFrame: From baseline, assessed up to 12 weeks.
measure: Number of accepted invites over the course of 12 weeks
timeFrame: From baseline, assessed up to 12 weeks.
measure: Frequency of physical activity sessions as a result of the technology-based intervention strategy over the course of 12 weeks
timeFrame: From baseline, assessed up to 12 weeks.
measure: Duration of physical activity sessions as a result of the technology-based intervention strategy over the course of 12 weeks
timeFrame: From baseline, assessed up to 12 weeks.
measure: Acceptance of health technology-based intervention strategy, as measured by the Mobile Application Rating Scale
timeFrame: Assessed at 12 weeks.
measure: Number of enrolled participants who complete the study
timeFrame: Assessed at 12 weeks.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network - Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Laura Passalent
role: PRINCIPAL_INVESTIGATOR
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