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

NCT ID: NCT06807853

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-11-30

Brief Summary

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

Axial Spondyloarthritis; Axial Spondyloarthritis (AxSpA); Axial Spondylarthritis (r-axSpA); Axial Spondyloarthopathy; Axial Spondyloarthritis and Ankylosing Spondylitis; Axial Spondyloarthritis, Non-Radiographic; Axial and Peripheral Spondyloarthritis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Smartwatch

Smartwatch AppleWatch SE to track Mobility

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with Axial Spondyloarthritis
• Patients do must have an own iPhone due to software reasons
• do must be willing and able to wear a Smartwatch
• do must be able to regularly fill out the PROs at home

Exclusion Criteria

• no iphone
• no physical or mental Ability to wear a Smartwatch
• no physical or mental Ability to regularly fill out the PROs at home

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

University of Bonn

OTHER

Sponsor Role: lead

Responsible Party

Valentin Schäfer

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital, Department for Rheumatology

Bonn, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Prof. Dr. med. Valentin S. Schaefer

Role: CONTACT

valentin.Schaefer@ukbonn.de

+49228287-17016

Dr. med. Lena Hatzmann

Role: CONTACT

lena.hatzmann@ukbonn.de

+4915158280464

Other Identifiers

MAIN457A_FVMBO009

Identifier Type: OTHER

Identifier Source: secondary_id

115/23

Identifier Type: -

Identifier Source: org_study_id