Health Technology to Improve Exercise in Ankylosing Spondylitis

Overseen By Laura Passalent

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Non-English, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if health technology, such as smartphone apps and emails, can help individuals with ankylosing spondylitis (a type of arthritis affecting the spine) remain more active. The trial will assess whether these tools can promote regular exercise, which is vital for managing symptoms and improving quality of life. One group of participants will use these tech tools as part of a health technology-based intervention strategy, while the other group will continue their usual care routines. Individuals with ankylosing spondylitis who use a smartphone and are part of the SPARCC Research Program may be well-suited for this study. As an unphased trial, this study provides a unique opportunity to explore innovative methods for enhancing daily life and managing symptoms effectively.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on increasing physical activity using health technology.

What prior data suggests that this health technology-based intervention strategy is safe?

Research shows that using health technology to encourage exercise is safe for people with ankylosing spondylitis, a type of arthritis affecting the spine. One study used wearable devices to help individuals with this condition exercise at home and found the devices safe and easy to use. Another study examined high-intensity interval training (HIIT) and found it improved heart health without worsening the condition.

These findings suggest that using apps and digital tools to encourage exercise is likely safe and can improve health without causing harm. For those considering joining a trial like this, the evidence so far indicates it's a safe way to become more active. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a health technology-based approach to boost exercise habits in people with ankylosing spondylitis (AS). Unlike traditional care, which often involves medication and standard exercise guidance, this intervention uses digital tools like educational modules and the ADAS application to encourage physical activity. This tech-driven strategy aims to make it easier for patients to integrate beneficial exercise routines into their daily lives, potentially leading to improved outcomes without additional medication. By leveraging technology, this approach could offer more personalized and consistent support, making it a promising addition to AS management.

What evidence suggests that this health technology-based intervention strategy is effective for improving exercise in ankylosing spondylitis?

Research has shown that exercise is crucial for managing axial spondyloarthritis (axSpA). A review of studies found that both supervised and home exercise programs can reduce symptoms in ankylosing spondylitis, a type of axSpA. Other studies indicate that digital exercise programs can decrease disease activity and improve health in these patients. Digital health tools, like mobile apps, have successfully encouraged regular exercise without increasing health risks. One small study suggested that technology-assisted home exercises can significantly improve health outcomes for axSpA patients. These findings support using health technology, such as the intervention tested in this trial, to enhance exercise participation and overall quality of life for people with axSpA. ^{1 6 7 8 9}

Who Is on the Research Team?

Laura Passalent

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for adults over 18 with axial spondyloarthritis (axSpA) who are part of the SPARCC Research Program. Participants must pass a health screen, have access to email and a smartphone, and be able to engage in physical activity without restrictions from other serious health issues.

Inclusion Criteria

Enrolled in the SPARCC Research Program

Passes pre-participation health screen

Have access to email and a smart phone device (Android or iOS operating systems)

Exclusion Criteria

Not enrolled in the SPARCC Research Program

I do not have health issues that stop me from being active.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive educational modules and access to health technology tools to encourage physical activity

12 weeks

Electronic communication at baseline, 3, 6, 9, and 12 weeks

Follow-up

Participants are monitored for changes in physical activity, exercise behavior, and health outcomes

12 weeks

Electronic assessments at baseline, 3, 6, 9, and 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Health technology-based intervention strategy

Trial Overview The study aims to develop and test a strategy using health technology like smartphone apps and emails to encourage regular exercise among axSpA patients. The goal is for participants to increase daily physical activity, which may improve symptoms and quality of life.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

Participants randomized to the intervention group will receive an initial electronic communication (i.e. email) that includes: * Link to physical activity education. This will be an educational module based on Phase 1 results and evidence-based literature regarding the benefits of physical activity in the general population and specific to axSpA. * One week after receiving the physical activity educational module, participants will receive access to the ADAS application and an .ics file for each 3-week cycle of electronic calendar reminders to engage in physical activity.

Group II: Control Group Active Control 1 Intervention

Participants randomized to the control group will receive usual care, which includes standard rheumatology care and access to educational materials on the importance of exercise and physical activity available through the TWH Spondylitis Program and through the public domain. They will receive a link to the physical activity educational module at baseline. They also have access to the program physiotherapist for a single one-hour individualized exercise consultation as requested by either the patient or the treating rheumatologist.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Canadian Initiative for Outcomes in Rheumatology Care

Collaborator

Trials

6

Recruited

540+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12421769/

Facilitators influencing participation in digitally-based high ... High-intensity interval training (HIIT) is an effective way to improve cardiovascular health without risk of increased disease activity.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12280830/

Effects of a Digital Functional Exercise Program on the ... A recent meta-analysis found that both supervised and home-based exercise programs are beneficial in reducing Bath Ankylosing Spondylitis ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06462937

NCT06462937 | A Digital Exercise Intervention in Patients ... Main objectives: To assess if a digital personally tailored exercise program with remote follow-up can reduce disease activity measured by ankylosing ...

4. thelancet.com thelancet.com/journals/lanrhe/article/PIIS2665-9913(24)00186-3/abstract

Digital health technologies to strengthen patient-centred ... Digital health technologies to strengthen patient-centred outcome assessment in clinical trials in inflammatory arthritis

5. jmir.org jmir.org/2022/1/e29703/

Randomized Pilot Controlled Clinical Trial Our pilot study suggests that this technology-assisted combined home-based exercise program can improve the clinical outcomes of patients with AS who have no ...

6. withpower.com withpower.com/trial/phase-spondylarthritis-8-2022-d1f2b

Health Technology to Improve Exercise in Ankylosing ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8808346/

Adherence, Efficacy, and Safety of Wearable Technology ... The goal of the research was to investigate the adherence, efficacy, and safety of a wearable technology–assisted combined home-based exercise program in AS.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0003496725009082

Remote monitoring or patient-initiated care in axial ... This study aimed to determine whether novel follow-up regimen, remote monitoring, or patient-initiated care is noninferior to usual care in maintaining low ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0003496724095335

Efficacy of a tight-control and treat-to-target strategy in axial ... This is the first study evaluating the efficacy of a treat-to-target and tight control (TC) approach in axSpA compared with UC.