Axial Spondyloarthritis
Conditions
Keywords
digital health, exercise, mobile app
Brief summary
The purpose of this study is to find out whether a mobile app called the ExerciseRx app is a practical and helpful way for people with axial spondyloarthritis (axSpA) to receive exercise recommendations as part of their regular rheumatology care. Researchers want to learn: Whether people with axSpA find the ExerciseRx app easy to use and helpful for supporting regular exercise. Whether using the ExerciseRx app leads to improvements in symptoms, physical function, and disease activity compared with usual care. Participants assigned to the ExerciseRx group will use the app to complete guided exercises for 20-30 minutes, four times per week. They will also receive personalized weekly step-count goals to help increase their physical activity. Researchers will compare outcomes between participants using the app and those receiving usual care.
Interventions
OTHERPhysical activity program intervention
Patients complete home exercise sessions given via the ExerciseRx app over 20-30 minutes 4 times per week for 12 weeks and receive daily step count goals. Patients also receive a FitBit to wear continuously throughout the study, and are given access to view their step counts via the ExerciseRx app, and receive an educational handout with exercises for axial spondyloarthritis.
OTHERUsual Care Group
Patients receive recommendations from their physicians to continue their usual physical activity as tolerated, receive a FitBit to wear continuously throughout the study, with the ExerciseRx app locked to the baseline home screen, and receive an educational handout with exercises for axial spondyloarthritis.
Sponsors
University of Washington
Arthritis Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of axial spondyloarthritis by a rheumatologist * English speaking * Insufficiently active (less than 150 minutes of moderate intensity aerobic activity per week) * Willing to wear a Fitbit for the study duration * Willing to have or create a Google account and download the Google Health app (previously known as the Fitbit app)
Exclusion criteria
* Currently pregnant * International travel or any circumstance causing lack of access to wi-fi/Internet at any point during the study period * Recent or planned surgery that may affect ability to engage in physical activity * Unable to exercise for health reasons, or a provider has recommended against exercising for safety/health reasons * Unable to walk safely without difficulty, or is a fall risk (i.e., 3+ falls in past 6 months) * History of a fall resulting in a fracture or head injury in the past 6 months * Cardiovascular contraindicators for physical activity, or history of cardiovascular problems that may be exacerbated by physical activity, as defined by their rheumatologist * Diabetes causing hypoglycemia following physical activity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average minutes of physical activity/exercise during the week and % of participants with adherence to 60% or higher of the recommended exercises | Week 0 (baseline), 6 and 12 | We will measure feasibility by adherence to the recommended exercises in the intervention arm, including any additional reported physical activity throughout each week. In the usual care arm, participants will report any physical therapy exercises completed from the handout, as well as other physical activity/exercise. Adherence will be measured using the modified Short QUestionnaire to ASsess Health-enhancing physical activity (mSQUASH), a validated tool for capturing physical activity in axSpA. For those in the intervention arm, adherence will also be captured via the built-in tracking features of the ExerciseRx app, providing an additional measure of feasibility. Adherence or engagement with the ExerciseRx app will be measured in three domains: frequency of app use, adherence to recommended exercises, and interaction with behavioral features. |
| Acceptability of the ExeriseRx app as a platform to complete recommended exercises for axial spondyloarthritis including % of participants with average score above 5 on MAUQ indicating usability | Weeks 6 and 12 | We will measure acceptability using the mHealth App Usability Questionnaire (MAUQ). Scores range from 1 to 7 with scores above 5 on a 7-point Likert scale considered to show usability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in disease activity over 12 weeks | Weeks 0 (baseline), 6, and 12 | We will measure changes in disease activity over the course of the study with Bath Axial Spondyloarthritis Disease Activity Index (BASDAI), a validated measure in axSpA. BASDAI ranges from 0-10 with 0 indicating remission and 10 indicated very high disease activity. |
| Change in functional status | Weeks 0 (baseline), 6, and 12 | We will measure changes in functional status over the course of the study via the Bath Axial Spondyloarthritis Functional Index (BASFI), a validated measure in axSpA. BASFI ranges from 0-10 with 0 indicating full function and 10 indicating severe functional impairment. |
Countries
United States
Contacts
CONTACTJoy Chan
PRINCIPAL_INVESTIGATORRachael Stovall, MD
University of Washington
Outcome results
None listed