Physical Activity Through Health Technology in Axial Spondyloarthritis
9 juni 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
40
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Joy Chan
- Telefoonnummer: 206-744-3626
- E-mail: joychan@uw.edu
Studie Locaties
-
-
Washington
-
Seattle, Washington, Verenigde Staten, 98195
- Werving
- University of Washington
-
Contact:
- Joy Chan
- Telefoonnummer: 206-744-3626
- E-mail: exerciserx@uw.edu
-
Seattle, Washington, Verenigde Staten, 98104
- Werving
- Harborview Medical Center
-
Contact:
- Joy Chan
- Telefoonnummer: 206-744-3626
- E-mail: exerciserx@uw.edu
-
Hoofdonderzoeker:
- Rachael Stovall, MD, MAS
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
|
Actieve vergelijker: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Average minutes of physical activity/exercise during the week and % of participants with adherence to 60% or higher of the recommended exercises
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in disease activity over 12 weeks
Tijdsspanne: 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
Tijdsspanne: 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
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Barriers and facilitators to physical activity/exercise
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Rachael Stovall, MD, University of Washington
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 juni 2026
Primaire voltooiing (Geschat)
1 april 2027
Studie voltooiing (Geschat)
1 juni 2027
Studieregistratiedata
Eerst ingediend
3 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
9 juni 2026
Eerst geplaatst (Werkelijk)
11 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
11 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
9 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- STUDY00024247
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .