Efficacy of Modification of Lifestyle in the Treatment of Ankylosing Spondylitis: a Pilot Study
Efficacy of Modification of Lifestyle in the Treatment of Ankylosing Spondylitis: a Pilot Study
NCT ID: NCT05666115 Phase: NA Status: COMPLETED Enrollment: 12 Completion: 2023-06-10
Conditions
Arthritis, Rheumatic Diseases, Autoimmune Diseases
Interventions
Probiotic group, Exercise group
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.
Primary Outcome
The primary outcome will be functional disability during daily life activities, evaluated with the Bath Ankylosing Spondylitis Functional Index.