Actively Recruiting
Symptom Assessment in Axial Spondyloarthritis Using Patient-Reported Outcomes and Smartwatch Mobility Tracking to Develop Movement Recommendations
Led by University of Bonn · Updated on 2025-02-18
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Bonn
Lead Sponsor
N
Novartis
Collaborating Sponsor
AI-Summary
What this Trial Is About
Axial spondyloarthritis (axSpa) is a chronic autoimmune disease affecting the back, causing pain, reduced function, and lower quality of life. Despite treatments like biological agents, only about 25% of patients reach remission. Physical activity plays an important role in controlling the disease, but daily movement patterns are not yet tracked in clinical practice. This study aims to analyze how different types, frequencies, and intensities of movement affect disease control and to develop clear movement recommendations for patients with axSpa. This is a monocentric longitudinal observational study where 50 participants with axSpa will be monitored over 6 months. Movement, physical activity, heart rate, and heart rate variability data are collected continuously using an AppleWatch SE smartwatch paired with a specially designed study app on the participant's own iPhone. Every two weeks, patients complete surveys about disease activity, pain, and function. Patients visit the clinic every 3 months for physical exams and assessments. Data from the smartwatch and surveys will be analyzed to create specific movement recommendations. Participants will wear the smartwatch and use the app to track activity and report symptoms throughout the 6-month study. Clinical visits occur every 3 months for examinations and medical history updates. Researchers measure outcomes such as daily steps, training and standing time, average heart rate, heart rate variability, pain levels, and disease activity. The goal is to provide concrete advice on movement to help manage axSpa symptoms, prevent flares, and improve recovery. The total participation time is 6 months with data collected continuously and surveys completed biweekly.
CONDITIONS
Brief Title
A LONGITUDINAL OBSERVATIONAL STUDY to EVALUATE the EFFICACY of MOVEMENT and IMPLEMENT CONCRETE MOVEMENT RECOMMENDATIONS with the HELP of MOBILITY TRACKING with SMARTWATCHES in SUBJECTS with AXIAL SPONDYLOARTHRITIS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with axial spondyloarthritis
- Own an iPhone to use the study app
- Willing and able to wear a smartwatch regularly
- Able to complete patient-reported outcome surveys at home regularly
You will not qualify if you...
- Do not have an iPhone
- Unable to wear a smartwatch due to physical or mental reasons
- Unable to complete patient-reported outcome surveys at home due to physical or mental reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - 24 weeks
Participants wear a smartwatch to track mobility and complete patient-reported outcome surveys at home regularly to evaluate movement and symptoms.
Continuous monitoring with smartwatch and regular remote surveys
Trial Site Locations
Total: 1 location
1
University Hospital, Department for Rheumatology
Bonn, North Rhine-Westphalia, Germany, 53127
Actively Recruiting
Research Team
P
Prof. Dr. med. Valentin S. Schaefer
D
Dr. med. Lena Hatzmann
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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