DRKS00033783招募中1 期
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 个研究点目标入组 200 人开始时间: 2024年3月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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