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Axial SpondyloarthritisSPARTAKUSNCT06807853

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

An observational study of Axial Spondyloarthritis and Axial Spondyloarthritis (AxSpA), run by University of Bonn at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 . Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Smartwatch
How many people
50 participants
Where
1 siteGermany
Study dates
1 Apr 2024to Nov 2025
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients prensenting in University Clinic Bonn, Department of Rheumatology

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Prof. Dr. med. Valentin S. Schaefer contact

+49228287-17016

valentin.Schaefer@ukbonn.de

Dr. med. Lena Hatzmann contact

+4915158280464

lena.hatzmann@ukbonn.de

Germany1 site, 1 recruiting

  • University Hospital, Department for Rheumatology

    Bonn, North Rhine-Westphalia, 53127

    Recruiting

Other trials in Germany

About this study

Official title: 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.

Read more

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".
Being tested
Smartwatch
Keywords
Mobility Tracking, Patient-Reported Outcomes (PROs), Disease Activity, Smartwatch, Study-App, Mobile Device, Movement Recommedations
Medical subject headings
Axial Spondyloarthritis, Spondylitis, Ankylosing, Non-Radiographic Axial Spondyloarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SmartwatchOther

    Smartwatch AppleWatch SE to track Mobility

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommendation for Rate of steps per day

    values: 0- >20.000

    Measured: From enrollment to Week 24

  2. Recommendation for minutes of training per day

    Measured: From enrollment to Week 24

  3. Recommendation for minutes of standing per day

    Measured: From enrollment to Week 24

  4. Recommendation for average heart frequence per day

    Measured: From enrollment to Week 24

  5. Recommendation for heart rate variability

    Measured: From enrollment to Week 24

Secondary outcomes (2)

  1. Numeric rating scale pain at week 24

    minimum value: 0 maximum value: 10, higher scores mean a worse outcome.

    Measured: From enrollment to Week 24

  2. 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 )

    Measured: From enrollment to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2025
  2. Study start1 Apr 2024
  3. Primary completionNov 2025 (estimated)
  4. Study completionNov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
50 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06807853
Sponsor's protocol ID
115/23
Other IDs
MAIN457A_FVMBO009
Acronym
SPARTAKUS
Status last verified
Feb 2025
First submitted
29 Jan 2025
Last updated
18 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Axial Spondyloarthritis and Axial Spondyloarthritis (AxSpA), run by University of Bonn at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Prof. Dr. med. Valentin S. Schaefer (+49228287-17016, valentin.Schaefer@ukbonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommendation for Rate of steps per day (time frame: From enrollment to Week 24). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06807853.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.

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SPARTAKUS Clinical Trial NCT06807853 | AzTrials