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Recruiting NCT07642622

Physical Activity Through Health Technology in Axial Spondyloarthritis

No phase Interventional Axial Spondyloarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Physical activity program intervention, Usual Care Group.
Who it may be relevant to
Registry conditions: Axial Spondyloarthritis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Expanding Access to Early Exercise Prescriptions for Underserved Patients With Axial Spondyloarthritis: A Digital Health Approach

Overview

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

  • Other Physical 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.
  • Other Usual 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.

Primary outcome measures

  • Average minutes of physical activity/exercise during the week and % of participants with adherence to 60% or higher of the recommended exercises [Time frame: 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 [Time frame: Weeks 6 and 12]
Secondary outcome measures (2)
  • Change in disease activity over 12 weeks [Time frame: Weeks 0 (baseline), 6, and 12]
  • Change in functional status [Time frame: Weeks 0 (baseline), 6, and 12]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Harborview Medical Center — Seattle
  • University of Washington — Seattle

Publications

  • 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. PMID 41618436

Identifiers

NCT: NCT07642622 · STUDY00024247

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗