Clinical trial NCT05666115: Efficacy of Modification of Lifestyle in the Treatment of Ankylosing Spondylitis: a Pilot Study
Official title: Efficacy of Modification of Lifestyle in the Treatment of Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis
Rheumatic Diseases
Autoimmune Diseases
Lead sponsor: Camilo Jose Cela University
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 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

Primary outcomes:
measure: The primary outcome will be functional disability during daily life activities, evaluated with the Bath Ankylosing Spondylitis Functional Index.
timeFrame: Change from Baseline BASFI at 4 and 12 weeks
Secondary outcomes:
measure: The secondary outcome will be disease activity during daily life activities, evaluated with the Bath Ankylosing Spondylitis Disease Activity Index.
timeFrame: Change from Baseline BASDAI at 4 and 12 weeks
measure: Spinal mobility will be measured with the Bath Ankylosing Spondylitis Metrology Index (BASMI)
timeFrame: Change from Baseline BASMI at 4 and 12 weeks
measure: The Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) 30 will be used to determine health-related quality of life
timeFrame: Change from Baseline ASQoL at 4 and 12 weeks
measure: Biochemical measures (interleukin-1 (IL-1) and tumor necrosis factor a (TNFa))
timeFrame: Change from Baseline biochemical measures at 4 and 12 weeks
Other outcomes:
Locations:
city: Arroyomolinos
country: Spain
facility: Elena Sonsoles Rodriguez Lopez
state: Madrid
Study officials:
References: