Efficacy of Modification of Lifestyle in the Treatment of Ankylosing Spondylitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- The primary outcome will be functional disability during daily life activities, evaluated with the Bath Ankylosing Spondylitis Functional Index.
研究概览
简要总结
Axial spondyloarthritis (axSpA) is a chronic inflammatory immune disorder with a global prevalence that ranges from 20 to 160 cases per 10000 individuals. axSpA has two forms of clinical presentation (radiographic and non-radiographic) based on the presence or absence of radiographic sacroiliitis. This condition mostly affects the vertebral spine, and is characterized by joint pain and stiffness, fatigue, and restricted function, which leads to a substantial physical, psychological, and socioeconomic burden. The clinical management of axSpA needs to combine pharmacological and non-pharmacological approaches to reduce inflammation and improve health-related quality of life.
The aim of the study will be to determine if a 12-week probiotic supplementation will be more effective than an online-delivered strength training program at improving functional capacity in adults with non-radiographic axSpA. As a secondary aim, we will compare the impact of both interventions on disease activity, spinal mobility, quality of life and biochemical measures. This will be the first randomized controlled trial where probiotics are compared with an active intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be aged 18 years or older and have a confirmed diagnosis of non-radiographic axSpA following the 2009 Assessment of the SpondyloArthritis International Society classification criteria
排除标准
- •Any systemic disease or comorbidity that may severely impair exercise capacity.
- •A high sensitivity C-reactive protein 10-fold greater than the normal upper limit (2.87 mg/l).
- •Any changes to medical treatment within the previous 2 months, and having an active peripheral arthritis
结局指标
主要结局
The primary outcome will be functional disability during daily life activities, evaluated with the Bath Ankylosing Spondylitis Functional Index.
时间窗: Change from Baseline BASFI at 4 and 12 weeks
The Bath Ankylosing Spondylitis Functional Index includes 10 items (scale of 0 to 10, higher scores denoting worse performance), and is among the recommended core set of instruments for axSpA.
次要结局
- The Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) 30 will be used to determine health-related quality of life(Change from Baseline ASQoL at 4 and 12 weeks)
- The secondary outcome will be disease activity during daily life activities, evaluated with the Bath Ankylosing Spondylitis Disease Activity Index.(Change from Baseline BASDAI at 4 and 12 weeks)
- Spinal mobility will be measured with the Bath Ankylosing Spondylitis Metrology Index (BASMI)(Change from Baseline BASMI at 4 and 12 weeks)
- Biochemical measures (interleukin-1 (IL-1) and tumor necrosis factor a (TNFa))(Change from Baseline biochemical measures at 4 and 12 weeks)
研究者
Elena Sonsoles Rodriguez López
Principal Investigator
Camilo Jose Cela University