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 (SPARTAKUS)

SYMPTOM-ACCESSMENT in SUBJECTS with AXIAL SPONDYLOARTHRITIS with PATIENT-REPORTED OUTCOMES and MOBILITY TRACKING with SMARTWATCHES VIA SPECIALLY PROGRAMMED STUDY-APP to EVALUATE the EFFICACY of MOVEMENT and IMPLEMENT CONCRETE MOVEMENT RECOMMENDATIONS

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".

Study Overview

• Status: Recruiting
• Conditions: Axial Spondyloarthritis; Axial and Peripheral Spondyloarthritis; Axial Spondyloarthopathy; Axial Spondyloarthritis and Ankylosing Spondylitis; Axial Spondyloarthritis (AxSpA); Axial Spondylarthritis (r-axSpA); Axial Spondyloarthritis, Non-Radiographic
• Intervention / Treatment: Other: Smartwatch

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Prof. Dr. med. Valentin S. Schaefer; Phone Number: +49228287-17016; Email: valentin.Schaefer@ukbonn.de
• Study Contact Backup: Name: Dr. med. Lena Hatzmann; Phone Number: +4915158280464; Email: lena.hatzmann@ukbonn.de

Study Locations

• Germany
  • NRW
    • Bonn, NRW, Germany, 53127
      • Recruiting
      • University Hospital, Department for Rheumatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients prensenting in University Clinic Bonn, Department of Rheumatology

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recommendation for Rate of steps per day	values: 0- >20.000	From enrollment to Week 24
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

Outcome Measure	Measure Description	Time Frame
Numeric rating scale pain at week 24	minimum value: 0 maximum value: 10, higher scores mean a worse outcome.	From enrollment to Week 24
Disease Activity depending on Movement of Patient	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 )	From enrollment to Week 24

Collaborators and Investigators

• Sponsor: University of Bonn
• Collaborators: Novartis; Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: January 29, 2025
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Smartwatch; Disease Activity; Mobile Device; Patient-Reported Outcomes (PROs); Mobility Tracking; Study-App; Movement Recommedations
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Infections; Bone Diseases, Infectious; Spinal Diseases; Spondylarthropathies; Ankylosis; Axial Spondyloarthritis; Non-Radiographic Axial Spondyloarthritis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: 115/23; MAIN457A_FVMBO009 (Other Identifier: Novartis)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No