Physical Activity Through Health Technology in Axial Spondyloarthritis

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Average minutes of physical activity/exercise during the week and % of participants with adherence to 60% or higher of the recommended exercises [Срок оценки: 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 [Срок оценки: Weeks 6 and 12]

Вторичные конечные точки (2)

• Change in disease activity over 12 weeks [Срок оценки: Weeks 0 (baseline), 6, and 12]
• Change in functional status [Срок оценки: Weeks 0 (baseline), 6, and 12]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Harborview Medical Center — Seattle
• University of Washington — Seattle

Публикации

• 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

Идентификаторы

NCT: NCT07642622 · STUDY00024247

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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