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Active Not Recruiting NCT05666115

Efficacy of Modification of Lifestyle in the Treatment of Ankylosing Spondylitis: a Pilot Study

Conditions: Arthritis, Rheumatic Diseases, Autoimmune Diseases

Sex: All
Ages: 18 Years – 60 Years
Phase: NA
Enrollment: 12
Sponsor: Camilo Jose Cela University

Location: Spain

Summary

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.

Eligibility Criteria

Inclusion Criteria: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 criteriaExclusion Criteria: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

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Source: ClinicalTrials.gov (NCT05666115). StuddyBuddy aggregates publicly available trial information.