Physical Activity Through Health Technology in Axial Spondyloarthritis
9 de junio de 2026 actualizado por: Rachael Stovall, University of Washington
Expanding Access to Early Exercise Prescriptions for Underserved Patients With Axial Spondyloarthritis: A Digital Health Approach
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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
40
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Joy Chan
- Número de teléfono: 206-744-3626
- Correo electrónico: joychan@uw.edu
Ubicaciones de estudio
-
-
Washington
-
Seattle, Washington, Estados Unidos, 98195
- Reclutamiento
- University of Washington
-
Contacto:
- Joy Chan
- Número de teléfono: 206-744-3626
- Correo electrónico: exerciserx@uw.edu
-
Seattle, Washington, Estados Unidos, 98104
- Reclutamiento
- Harborview Medical Center
-
Contacto:
- Joy Chan
- Número de teléfono: 206-744-3626
- Correo electrónico: exerciserx@uw.edu
-
Investigador principal:
- Rachael Stovall, MD, MAS
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: ExerciseRx app
the ExerciseRx app with personalized exercise recommendations, an educational handout, Fitbit-guided step goals, and physical therapy referral
|
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.
|
|
Comparador activo: Usual care
An educational handout, Fitbit monitoring without step goals, and physical therapy referral
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Average minutes of physical activity/exercise during the week and % of participants with adherence to 60% or higher of the recommended exercises
Periodo de tiempo: 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.
|
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
Periodo de tiempo: 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.
|
Weeks 6 and 12
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in disease activity over 12 weeks
Periodo de tiempo: 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.
|
Weeks 0 (baseline), 6, and 12
|
|
Change in functional status
Periodo de tiempo: 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.
|
Weeks 0 (baseline), 6, and 12
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Barriers and facilitators to physical activity/exercise
Periodo de tiempo: Weekly throughout the 12 week study
|
Participants will receive weekly surveys from the ExerciseRx app regarding any barriers and facilitator to physical activity/exercise during the week.
|
Weekly throughout the 12 week study
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Rachael Stovall, MD, University of Washington
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de junio de 2026
Finalización primaria (Estimado)
1 de abril de 2027
Finalización del estudio (Estimado)
1 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
3 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
9 de junio de 2026
Publicado por primera vez (Actual)
11 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00024247
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .