Physical Activity Through Health Technology in Axial Spondyloarthritis

NCT07642622 | Recruiting DMC

• 1 other identifier: STUDY00024247
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Axial Spondyloarthritis

Keywords

digital health; exercise; mobile app

Outcome Measures

Primary Outcomes (2)

• Average minutes of physical activity/exercise during the week and % of participants with adherence to 60% or higher of the recommended exercises

  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.

  Week 0 (baseline), 6 and 12

• 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

  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.

  Weeks 6 and 12

Secondary Outcomes (2)

• Change in disease activity over 12 weeks

  Weeks 0 (baseline), 6, and 12

• Change in functional status

  Weeks 0 (baseline), 6, and 12

Other Outcomes (1)

• Barriers and facilitators to physical activity/exercise

  Weekly throughout the 12 week study

Study Arms (2)

ExerciseRx app

EXPERIMENTAL

the ExerciseRx app with personalized exercise recommendations, an educational handout, Fitbit-guided step goals, and physical therapy referral

Other: Physical activity program intervention

Usual care

ACTIVE COMPARATOR

An educational handout, Fitbit monitoring without step goals, and physical therapy referral

Other: Usual Care Group

Interventions

Usual Care Group OTHER

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.

Usual care

Physical activity program intervention OTHER

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.

ExerciseRx app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Arthritis Foundation: collaborator

Study Sites (2)

Harborview Medical Center

Seattle, Washington, 98104, United States

RECRUITING

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

Related Publications (1)

• Stovall R, Li R, Liew JW, Lui A, Patel S, Friedly J, Lin CY. Evaluating the performance and acceptability of an artificial intelligence digital health exercise platform in females with and without axial spondyloarthritis: a phase I study. Adv Rheumatol. 2026 Jan 30;66(1):17. doi: 10.1186/s42358-026-00519-1. No abstract available.

  PMID: 41618436 BACKGROUND

MeSH Terms

Conditions

Axial Spondyloarthritis; Motor Activity

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Behavior

Study Officials

• Rachael Stovall, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joy Chan

CONTACT

206-744-3626; joychan@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Acting Assistant Professor: School of Medicine, Rheumatology

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 11, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

US (2)