Health Technology to Improve Exercise in axSpA

November 2, 2022 updated by: Laura Passalent, University Health Network, Toronto

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • University Health Network - Toronto Western Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group

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.
Other: Health technology-based intervention strategy
Patient-centered, technology-based intervention strategy aimed at increasing physical activity in patients with axSpA
No Intervention: Control Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in levels of physical activity as measured by the International Physical Activity Questionnaire-Short Form questionnaire (IPAQ-SF)
Time Frame: 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.
Assessed electronically by an e-survey platform at baseline, 3, 6, 9 and 12 weeks in the intervention and control groups.
Changes in exercise behaviour as measured by an adapted Stanford Exercise Behaviours Questionnaire
Time Frame: Assessed 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.
Assessed electronically by an e-survey platform at baseline, 3, 6, 9 and 12 weeks in the intervention and control groups.
Change in levels of physical activity as measured by Accelerometry
Time Frame: Assessed 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.
Assessed at baseline and at 12 weeks.
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)
Time Frame: Assessed at baseline and at 12 weeks.
The EBBS measures perceptions regarding the benefits of, and barriers to, exercise.
Assessed at baseline and at 12 weeks.
Change in functioning and health as a result of the technology-based intervention strategy as measured by the ASAS Health Index
Time Frame: Assessed 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'
Assessed at baseline and at 12 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in disease activity over the course of 12 weeks as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDI) questionnaire
Time Frame: From 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.
From baseline, assessed up to 12 weeks.
Change in function over the course of 12 weeks as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) questionnaire
Time Frame: From baseline, assessed up to 12 weeks.
Function as measured by the BASFI questionnaire (0 - 10 visual analog scale) weekly.
From baseline, assessed up to 12 weeks.
Number of accepted invites over the course of 12 weeks
Time Frame: From baseline, assessed up to 12 weeks.
Acceptance of planned exercise, as measured by uptake of health technology-based intervention strategy
From baseline, assessed up to 12 weeks.
Frequency of physical activity sessions as a result of the technology-based intervention strategy over the course of 12 weeks
Time Frame: From baseline, assessed up to 12 weeks.
Acceptance of planned exercise, as measured by uptake of health technology-based intervention strategy
From baseline, assessed up to 12 weeks.
Duration of physical activity sessions as a result of the technology-based intervention strategy over the course of 12 weeks
Time Frame: From baseline, assessed up to 12 weeks.
Acceptance of planned exercise, as measured by uptake of health technology-based intervention strategy
From baseline, assessed up to 12 weeks.
Acceptance of health technology-based intervention strategy, as measured by the Mobile Application Rating Scale
Time Frame: Assessed 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.
Assessed at 12 weeks.
Number of enrolled participants who complete the study
Time Frame: Assessed at 12 weeks.
Adherence, as measured by the rate of study completion.
Assessed at 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Canadian Initiative for Outcomes in Rheumatology Care

Investigators

  • Principal Investigator: Laura Passalent, University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

July 29, 2022

First Submitted That Met QC Criteria

August 15, 2022

First Posted (Actual)

August 17, 2022

Study Record Updates

Last Update Posted (Actual)

November 3, 2022

Last Update Submitted That Met QC Criteria

November 2, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-5919

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Axial Spondyloarthritis

Clinical Trials on Health technology-based intervention strategy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe