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

Not Applicable

Completed

• Conditions: Autoimmune Diseases; Rheumatic Diseases; Arthritis
• Interventions: Other: Exercise group; Dietary Supplement: Probiotic group

• Registration Number: NCT05666115
• Lead Sponsor: Camilo Jose Cela University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-22
• Study First Submitted QC: 2022-12-16
• Study First Posted: 2022-12-27
• Study Start: 2023-01-02
• Status Verified: 2023-06
• Primary Completion: 2023-06-10
• Study Completion: 2023-06-10
• Last Update Submitted: 2023-06-14
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise group	Exercise group	The control group will undergo a 12-week online-delivered Tabata program, as a form of high-intensity interval training.
Probiotic group	Probiotic group	Participants in the probiotics group will receive probiotic supplementation for 12 weeks.

Primary Outcome Measures

Name	Time	Method
The primary outcome will be functional disability during daily life activities, evaluated with the Bath Ankylosing Spondylitis Functional Index.	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.

Secondary Outcome Measures

Name	Time	Method
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 ASQoL is valid, feasible and reliable. Total score range between 0 and 18, with higher scores indicating poorer quality of life.
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	Disease activity will be assessed with the Bath Ankylosing Spondylitis Disease Activity Index. The Bath Ankylosing Spondylitis Disease Activity Index explores five different constructs (fatigue, spinal or peripheral joint pain, localized tenderness, and morning stiffness), with lower scores representing less disease activity (scale of 0 to 10).
Spinal mobility will be measured with the Bath Ankylosing Spondylitis Metrology Index (BASMI)	Change from Baseline BASMI at 4 and 12 weeks	Bath Ankylosing Spondylitis Metrology Index as a composite index including lumbar flexion and side flexion (cm), tragus-to-wall and intermalleolar distance (cm), and cervical rotation (degrees). Final scores of the BASMI range from 0 "no mobility limitation" to 10 "severe limitation".
Biochemical measures (interleukin-1 (IL-1) and tumor necrosis factor a (TNFa))	Change from Baseline biochemical measures at 4 and 12 weeks	A PeliKine compact enzyme-linked immunosorbent assay (ELISA) kit will be used to explore two inflammatory biomarkers

Trial Locations

Locations (1)

Elena Sonsoles Rodriguez Lopez; 🇪🇸 Arroyomolinos, Madrid, Spain