M45
Conditions
Interventions
Group 1: The intervention arm is allowed to use the Axia app for 12 weeks after having received treatment as usual for 12 weeks
Sponsors
Universitätsklinikum Würzburg, Medizinische Klinik II, Rheumatologie/ Klinische Immunologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Minimum age of 18 years Specialist-confirmed diagnosis of axSpA (verification by a document issued by a specialist) and regular follow-up with an appropriate specialist (internal medicine, rheumatology, orthopedics, or general medicine) for the treatment of axSpA Stable treatment situation, in particular: For biologics/JAK inhibitors/sulfasalazine/methotrexate: stable dose for the last 8 weeks prior to study inclusion and throughout the study For NSAIDs: stable dose for the last 2 weeks prior to study inclusion and throughout the study No planned change in therapy within the next 12 weeks BASDAI score = 3.0 (assessed at screening) With reference to the past 4 weeks on average: At most 4 times per week of independent home-based axSpA-specific exercise, with a total duration of no more than 50 minutes At most 3 times per week of regular sports activities (including strength training, endurance sports, team sports, yoga, Pilates, and other sports), group exercise, or functional training, with a total duration of no more than 90 minutes With reference to the past 3 months prior to study inclusion: on average at most 1 physiotherapy session per week (individual treatment), and no planned increase in physiotherapy during the study Sufficient knowledge of the German language (able to complete questionnaires independently) Possession of a personal Android or iOS smartphone with mobile internet access, meeting the technical requirements for the use of the Bechterew app Adequate smartphone skills (participants who describe themselves as experienced in using smartphone apps and who report having independently used apps in the past) Willingness to undergo MRI examination Willingness to undergo bioimpedance measurement Willingness to attend three on-site visits at the study center
Exclusion criteria
Exclusion criteria: Lack of capacity to provide informed consent Current pregnancy Medical conditions that could pose a risk for increased exercise training. These include in particular: advanced heart failure (NYHA class III/IV), angina pectoris, severe COPD (GOLD stage 3/4), peripheral arterial disease > stage II B, obesity = grade III, active infectious diseases, acute malignant disease, myocardial infarction within the last 24 weeks prior to study inclusion, movement-restricting neurological diseases, acute orthopedic injury (e.g., fracture, ligament sprain), status post limb amputation, ongoing or planned chemotherapy or radiotherapy (list not exhaustive) Participants who, due to other health restrictions not specified under 8.3.2, are unable to engage in daily exercise Presence of an absolute contraindication to app usage according to the manufacturer’s specifications Current active use of another smartphone app for the treatment of axSpA. This also includes “fitness apps” that are not specifically designed for axSpA patients but are nevertheless used by potential participants as a therapeutic tool for axSpA Anatomical alterations that make assessment by MRI or by the EasyTorque device for isometric strength measurement impossible MRI-specific exclusion criteria: Claustrophobia Panic attacks or discomfort during previous MRI examinations Non-MRI-compatible implants (osteosynthesis material, pacemakers, prostheses, dental implants, etc.) Tattoos with iron-containing pigments, permanent makeup, transdermal patches Ventricular shunt Bioimpedance measurement exclusion criteria: Pacemaker Active prostheses
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of BASMI after week 24 compared to week 12 and week 0. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of the following variables at Week 24 compared to Week 12 and Week 0: - SPARCC SIS MRI score of the sacroiliac joints - SPARCC SSS MRI score of the sacroiliac joints - Functional strength - Isometric strength of the rectus abdominis and back muscles - Body composition (bioelectrical impedance) - Sexuality (Qualisex) - Sleep quality (ISI) - Work productivity (WPAI:SpA) - Fear of disease progression (PA-F-KF) - Quality of life (VR-12) - Depressiveness (PHQ-4) - Disease activity (BASDAI) - Analgesic requirements (Quantitative Analgesic Questionnaire, QAQ) Assessed once at Week 24: - Willingness to recommend (Net Promoter Score) - Evaluation of usability (uMARS) | — |
Countries
Germany
Contacts
Public ContactPatrick-Pascal Strunz
Universitätsklinikum Würzburg, Medizinische Klinik II, Rheumatologie/ Klinische Immunologie
Outcome results
None listed