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Health Technology to Improve Exercise in axSpA

Physical Activity in Axial Spondyloarthritis: Development and Implementation of an Evidence-Based Health Technology Approach to Improve Adherence to Recommended Guidelines

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05504616
Enrollment
106
Registered
2022-08-17
Start date
2022-07-21
Completion date
2024-12-31
Last updated
2022-11-03

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

Conditions

Axial Spondyloarthritis

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.

Interventions

OTHERHealth technology-based intervention strategy

Patient-centered, technology-based intervention strategy aimed at increasing physical activity in patients with axSpA

Sponsors

Canadian Initiative for Outcomes in Rheumatology Care
CollaboratorOTHER
University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Repeated measures randomized control pre-test/post-test design comparing an intervention group with a control group (usual care).

Eligibility

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

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.)

Design outcomes

Primary

MeasureTime frameDescription
Changes in levels of physical activity as measured by the International Physical Activity Questionnaire-Short Form questionnaire (IPAQ-SF)Assessed electronically by an e-survey platform at baseline, 3, 6, 9 and 12 weeks in the intervention and control groups.The IPAQ-SF is a self-report questionnaire designed to estimate total physical activity in MET-min/week by assessing the types of intensity of physical activity and sitting time that people do as part of their daily lives.
Changes in exercise behaviour as measured by an adapted Stanford Exercise Behaviours QuestionnaireAssessed electronically by an e-survey platform at baseline, 3, 6, 9 and 12 weeks in the intervention and control groups.2-item questionnaire measuring total time (minutes) spent on stretching and strengthening exercises each week.
Change in levels of physical activity as measured by AccelerometryAssessed at baseline and at 12 weeks.Participants wear an accelerometer for 7 consecutive days at baseline and again at 12 weeks. The participant will mail back the activity monitor using a pre-paid envelope following each seven-day period.
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)Assessed at baseline and at 12 weeks.The EBBS measures perceptions regarding the benefits of, and barriers to, exercise.
Change in functioning and health as a result of the technology-based intervention strategy as measured by the ASAS Health IndexAssessed at baseline and at 12 weeks.The self-report questionnaire measures functioning and health across 17 aspects of health and 9 environmental factors in patients with spondyloarthritis. The items measure the concept of 'functioning, disability and health'

Secondary

MeasureTime frameDescription
Acceptance of health technology-based intervention strategy, as measured by the Mobile Application Rating ScaleAssessed at 12 weeks.Acceptance of intervention, as measured by the Mobile Application Rating Scale. MARS is a 5-point scale from 1-inadequate or strongly disagree to 5-excellent or strongly agree that accesses app quality, app subjective quality, and perceived impact of the app on user's knowledge, intentions to change as well as the likelihood of actual change in the target health behaviour. Higher scores indicate greater quality and acceptance of the intervention.
Change in disease activity over the course of 12 weeks as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDI) questionnaireFrom baseline, assessed up to 12 weeks.Disease activity, including pain, fatigue and stiffness as measured by the BASDAI questionnaire (a 0 - 10 visual analog scale) weekly.
Number of enrolled participants who complete the studyAssessed at 12 weeks.Adherence, as measured by the rate of study completion.
Change in function over the course of 12 weeks as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) questionnaireFrom baseline, assessed up to 12 weeks.Function as measured by the BASFI questionnaire (0 - 10 visual analog scale) weekly.
Number of accepted invites over the course of 12 weeksFrom baseline, assessed up to 12 weeks.Acceptance of planned exercise, as measured by uptake of health technology-based intervention strategy
Frequency of physical activity sessions as a result of the technology-based intervention strategy over the course of 12 weeksFrom baseline, assessed up to 12 weeks.Acceptance of planned exercise, as measured by uptake of health technology-based intervention strategy
Duration of physical activity sessions as a result of the technology-based intervention strategy over the course of 12 weeksFrom baseline, assessed up to 12 weeks.Acceptance of planned exercise, as measured by uptake of health technology-based intervention strategy

Countries

Canada

Contacts

Primary ContactJennifer Dutra
jennifer.dutra@uhnresearch.ca(416) 603-5800
Backup ContactLaura Passalent
laura.passalent@uhn.ca(416) 603-5800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026