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

Camilo Jose Cela University

Status: Completed

Conditions: Arthritis; Rheumatic Diseases; Autoimmune Diseases

Treatments: Other: Exercise group; Dietary Supplement: Probiotic group

Study type: Interventional

Funder types: Other

Identifiers

NCT05666115

EMLAS

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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 criteria

Exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 2 patient groups

Probiotic group

Experimental group

Description:

Participants in the probiotics group will receive probiotic supplementation for 12 weeks.

Treatment:

Dietary Supplement: Probiotic group

Exercise group

Active Comparator group

Description:

The control group will undergo a 12-week online-delivered Tabata program, as a form of high-intensity interval training.

Treatment:

Other: Exercise group