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

Recruiting

• 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

• Registration Number: NCT06807853
• Lead Sponsor: University of Bonn

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".

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-01
• Study First Submitted: 2025-01-29
• Study First Submitted QC: 2025-01-29
• Status Verified: 2025-02
• Study First Posted: 2025-02-04
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-18
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recommendation for Rate of steps per day	From enrollment to Week 24	values: 0- \>20.000
Recommendation for minutes of training per day	From enrollment to Week 24
Recommendation for minutes of standing per day	From enrollment to Week 24
Recommendation for average heart frequence per day	From enrollment to Week 24
Recommendation for heart rate variability	From enrollment to Week 24

Secondary Outcome Measures

Name	Time	Method
Numeric rating scale pain at week 24	From enrollment to Week 24	minimum value: 0 maximum value: 10, higher scores mean a worse outcome.
Disease Activity depending on Movement of Patient	From enrollment to Week 24	using: * Numeric rating scale disease activity (NRS DA, values 0-10, best value: 0, worst value: 10),; * Bath Ankylosing Spondylitis Disease Activity Index (BASDAI, values 0-10, best value 0, worst value 10); * Bath Ankylosing Spondylitis Functional Index (BASFI, values 0-10, best value 0, worst value 10),; * Gesundheitsindex Axiale Spondyloarthritis - ASA-Score (ASAS, values: 0-17, best value: 0, worst value: 17),; * European Quality of Life 5 Dimensions Score (EQ-5D, for each dimension a 1-digit number expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state, best combined value 11111, worst combined value 55555),; * Morning stiffness Score (scale from 0 minutes to \>60 minues, worst value:\>60 min),; * Facit Fatigue Score (values 8-44, best value 44, value \< 30: suspicious for severe fatigue),; * Funktionsfragebogen Hannover (FFbH, values 0- 36, best value: 36, worst value 0 )

Trial Locations

Locations (1)

University Hospital, Department for Rheumatology; 🇩🇪 Bonn, NRW, Germany