Study on the efficiacy of an app-based intervention in patients with axial spondyloarthritis.

Phase 1

Recruiting

Conditions: M45
Ankylosing spondylitis

Registration Number: DRKS00033783

Lead Sponsor: niversitätsklinikum Würzburg, Medizinische Klinik II, Rheumatologie/ Klinische Immunologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

Clinically confirmed axSpA and regular connection to an appropriate specialist physician
Stable therapy situation
BASDAI score of = 3.5 in the screening questionnaire
Referring to the past 4 weeks on average:
Maximum of 4 times per week independent execution of axSpA-specific exercises at home, totaling a maximum of 50 minutes per week
Maximum of 3 times per week regular participation in sports (including strength training, endurance sports, team sports, yoga, pilates, and other sports), group gymnastics, or functional training, totaling a maximum of 90 minutes.
Referring to the last 3 months before study enrollment, on average, a maximum of 1 session per week of individual physiotherapy with no planned increase during the study
Sufficient proficiency in the German language
Ownership of an Android or iOS-compatible smartphone with mobile internet access, meeting the necessary requirements for using the Bechterew app
Adequate smartphone competence

Exclusion Criteria

Lack of capacity to consent
Current pregnancy
Conditions that could pose a risk for increased exercise training. These include particularly advanced heart failure (NYHA 3/4), angina pectoris, severe COPD GOLD 3/4), peripheral arterial occlusive disease (pAVK) = Grade II B, obesity from Grade III onwards, active infectious diseases, acute malignant disease, status post myocardial infarction within the last 24 weeks prior to study enrollment, movement-limiting neurological diseases, acute orthopedic injury (e.g., fracture, ligament strain), status post limb amputation, ongoing or planned chemotherapy or radiation therapy (non-exhaustive list)
Study participant is unable to engage in daily exercise due to other health restrictions not mentioned in Chapter 8.3.2
Presence of an absolute contraindication to app usage as per manufacturer instructions
Current active use of another smartphone app for the therapy of axSpA

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in ASQoL score (quality of life) after 12 weeks<br>Change in BASDAI score (disease activity) after 12 weeks<br>Change in BASFI score (functionality or disease-related difficulties in daily life) after 12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in the following variables at different time points (Week 8, 12, 26, 52):<br><br>ASQoL (quality of life; Week 8, 26, and Week 52)<br>BASDAI (disease activity; Week 8, 26, and Week 52)<br>BASFI (functionality or disease-related difficulties in daily life; Week 8, 26, and Week 52)<br>EARS (adherence to recommended exercise therapy; all time points)<br>HLS EU-Q16 (health literacy; only Week 8 and 12)<br>Patient Global Assessment (disease activity; all time points)<br>NRS Pain (pain; all time points)<br>ASKU (patient empowerment; all time points)<br>Occurrence of adverse events (safety endpoint; all time points)