Actively Recruiting

Age: 18Years +
All Genders
NCT06807853

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

Led by University of Bonn · Updated on 2025-02-18

50

Participants Needed

1

Research Sites

82 weeks

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 inflammatoric autoimmune disease of the back with a prevalence around 1,4% (1) . In patients decreased function and decreased quality of life as well as chronic pain are strong burdens . Despite modern treatments like biological agents just 25% of the patients are at remission (2) . Besides the pharmacological treatment physical activity is known to be very important to gain disease control. A low physical activity is related to a higher disease activity and a high physical activity to better disease control. Until now there is no structured capture of the daily movements of patients with axial spondylarthritis in clinical practice. Our goal is to analyse the relationship between movement and disease activity and to implement concrete recommendations for movement in patients with axSpa. The primary objective of the study is to investigate which type, frequency and intensity of movement are helpful in gaining and remaining disease control in patients with axSpa. Methods This monocentric longitudinal study recordes movement, sport and physical parameters like heart frequency and heart rate variability through an observational period of 6 month via smartwatch. Meanwhile we record disease activity, pain and functional outcomes with regular surveys every two weeks. Patients in every phase of disease are eligible for inclusion, but they do must have an own iPhone due to software reasons. Data is collected in a specially programmed study-app. Fifty participants will be included in this study. Until now we have 24 patients included since april 2024. Patients come to clinic every 3 month as this is our standard in outclinic patients. We than do anamnesis and a physical examination. After the study period of 6 month we transmit the mobility and disease-related data of the surveys of the patients mobile device to our system. The primary endpoint is to find exact recommendations for concrete movement in patients with axSpa. So this is the first study that wants to give concrete recommendations for movement in patients with axSpa with the help of mobility tracking with smartwatches. This could help to prevent flares and also to recover quicker from a flare. 1. López-Medina und Moltó, "Update on the epidemiology, risk factors, and disease outcomes of axial spondyloarthritis". 2. Pina Vegas u. a., "Factors associated with remission at 5-year follow-up in recent-onset axial spondyloarthritis: results from the DESIR cohort".

CONDITIONS

Official 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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with Axial Spondyloarthritis
  • Must own an iPhone
  • Willing and able to wear a smartwatch
  • Able to regularly complete patient-reported outcome surveys at home
Not Eligible

You will not qualify if you...

  • Do not own an iPhone
  • Unable to physically or mentally wear a smartwatch
  • Unable to physically or mentally complete patient-reported outcome surveys regularly at home

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospital, Department for Rheumatology

Bonn, North Rhine-Westphalia, Germany, 53127

Actively Recruiting

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Research Team

P

Prof. Dr. med. Valentin S. Schaefer

CONTACT

D

Dr. med. Lena Hatzmann

CONTACT

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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