M46
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with a diagnosis of spondyloarthritis will be recruited for the study. Written consent to study participation and data protection.
Exclusion criteria
Exclusion criteria: Pregnancy. No change of systemic immunosuppressive therapy in the last 3 months and in the intervention period (follow-up is excluded). No current benefit from ViViRA or Kaia App or previous inclusion in an exercise-related DiGA study. Previous exercise coaching. App-specific exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. compliance with DiGA use: - Investigation of how coaching (AI-based or personalized coaching) improves compliance when using DiGA versus DiGA without coaching. 2. compliance with regular physical activity: - Investigating how personalized coaching in the gym/strength training improves physical activity and exercise competence in rheumatic patients compared to physiotherapy. 3. mobility and physical function: - Examining how coaching affects range of motion (BASMI, physical measurements), gait (sensors), physical function in the context of disease (BASFI), strength (dynamometer), and functional limitations in daily living (HAQ). 4. pain and disease activity: - Examination of how coaching affects disease activity (BASDAI), inflammatory markers (CRP, interleukin) and pain (PAIN, VAS, Korff, PDI). 5. movement competence: - Examination of how coaching affects exercise competence (PAHCO), physical activity (WHO), BMI and fear of exercise (TSK). 6. quality of life: - Investigating how coaching affects quality of life (SF-36), sleep habits (PSQI) and work productivity (WPAI). | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison between the five groups (Kaia, ViViRA + coach, ViViRA, strength training + coach, strength training) in terms of physical and psychological parameters measured using the questionnaires described above - Differences in laboratory results between the five groups (Kaia, ViViRA + coach, ViViRA, strength training + coach, strength training) - Difference in cardiopulmonary outcomes between the five groups (Kaia, ViViRA + Coach, ViViRA, strength training + Coach, strength training) - Long-term observation after 24 and after 36 weeks in all five groups | — |
Countries
Germany
Contacts
Uniklinik Erlangen