Physical Activity Through Health Technology in Axial Spondyloarthritis

ConditionAxial Spondyloarthritis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Washington

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Physical activity program intervention
Other 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.
Usual Care Group
Other intervention
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.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: ExerciseRx appExperimental treatment 1 intervention

Group B: Usual careActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

Weeks 6 and 12

Secondary outcomes

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.

Time frame

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.

Time frame

Weeks 0 (baseline), 6, and 12

Other outcomes

Barriers and facilitators to physical activity/exercise

Participants will receive weekly surveys from the ExerciseRx app regarding any barriers and facilitator to physical activity/exercise during the week.

Time frame

Weekly throughout the 12 week study

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Washington

Lead sponsor

Arthritis Foundation

Collaborator

Source ClinicalTrials.gov

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