Physical Activity Through Health Technology in Axial Spondyloarthritis
9 juni 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
40
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Joy Chan
- Telefonnummer: 206-744-3626
- E-post: joychan@uw.edu
Studieorter
-
-
Washington
-
Seattle, Washington, Förenta staterna, 98195
- Rekrytering
- University of Washington
-
Kontakt:
- Joy Chan
- Telefonnummer: 206-744-3626
- E-post: exerciserx@uw.edu
-
Seattle, Washington, Förenta staterna, 98104
- Rekrytering
- Harborview Medical Center
-
Kontakt:
- Joy Chan
- Telefonnummer: 206-744-3626
- E-post: exerciserx@uw.edu
-
Huvudutredare:
- Rachael Stovall, MD, MAS
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Aktiv komparator: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Average minutes of physical activity/exercise during the week and % of participants with adherence to 60% or higher of the recommended exercises
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in disease activity over 12 weeks
Tidsram: 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
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Barriers and facilitators to physical activity/exercise
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Rachael Stovall, MD, University of Washington
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juni 2026
Primärt slutförande (Beräknad)
1 april 2027
Avslutad studie (Beräknad)
1 juni 2027
Studieregistreringsdatum
Först inskickad
3 juni 2026
Först inskickad som uppfyllde QC-kriterierna
9 juni 2026
Första postat (Faktisk)
11 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STUDY00024247
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
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