DRKS00033783
Recruiting
Phase 1
Study on the efficiacy of an app-based intervention in patients with axial spondyloarthritis. - Bechterew-App Study 1
niversitätsklinikum Würzburg, Medizinische Klinik II, Rheumatologie/ Klinische Immunologie0 sites200 target enrollmentStarted: March 1, 2024Last updated:
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- niversitätsklinikum Würzburg, Medizinische Klinik II, Rheumatologie/ Klinische Immunologie
- Enrollment
- 200
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to one (—)
- Sex
- All
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
Investigators
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