Axial SpondyloarthritisNCT07642622
Physical Activity Through Health Technology in Axial Spondyloarthritis
A study testing Physical activity program intervention in people with Axial Spondyloarthritis, run by University of Washington at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Axial Spondyloarthritis
- What is being tested?
- Physical activity program intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Harborview Medical Center
Seattle, Washington, 98104
Joy Chan, 206-744-3626, exerciserx@uw.edu
Rachael Stovall, MD, MAS
- Recruiting
University of Washington
Seattle, Washington, 98195
Joy Chan, 206-744-3626, exerciserx@uw.edu
About this study
Official title: 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:
Read more
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.
- Conditions
- Axial Spondyloarthritis
- Being tested
- Physical activity program intervention, Usual Care Group
- Keywords
- digital health, exercise, mobile app
- Medical subject headings
- Axial Spondyloarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity program interventionOther
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.
Usual Care GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ExerciseRx app | Experimental | the ExerciseRx app with personalized exercise recommendations, an educational handout, Fitbit-guided step goals, and physical therapy referral Receives: Other: Physical activity program intervention |
| Usual care | Active comparator | An educational handout, Fitbit monitoring without step goals, and physical therapy referral Receives: Other: Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average minutes of physical activity/exercise during the week and % of participants with adherence to 60% or higher of the recommended exercises
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.
Measured: 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
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.
Measured: Weeks 6 and 12
Secondary outcomes (2)
Change in disease activity over 12 weeks
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.
Measured: Weeks 0 (baseline), 6, and 12
Change in functional status
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.
Measured: Weeks 0 (baseline), 6, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Arthritis Foundation
- Responsible party
- Principal investigator, Rachael Stovall, University of Washington
- Investigators
- Rachael Stovall, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642622
- Sponsor's protocol ID
- STUDY00024247
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 41618436
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Access to Early Exercise Prescriptions for Underserved Patients With Axial Spondyloarthritis: A Digital Health Approach
- ClinicalTrials.gov ID
- NCT07642622
- Acronym / sponsor ID
- STUDY00024247
- Conditions
- Axial Spondyloarthritis
- Keywords
- digital health, exercise, mobile app
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Arthritis Foundation
- Study start
- Jun 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ExerciseRx app | Experimental | Other: Physical activity program interventionthe ExerciseRx app with personalized exercise recommendations, an educational handout, Fitbit-guided step goals, and physical therapy referral |
| Usual care | Active comparator | Other: Usual Care GroupAn educational handout, Fitbit monitoring without step goals, and physical therapy referral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity program interventionPatients 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 | ExerciseRx app |
| Usual Care GroupPatients 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. | Other | Usual care |
Primary outcome
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
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.
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
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Background: PubMed 41618436Stovall 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachael Stovall, MD principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity program intervention in people with Axial Spondyloarthritis, run by University of Washington at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joy Chan (206-744-3626, joychan@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07642622, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.