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

Arthritis Clinical Trial

— EMLAS  

Official title:

Efficacy of Modification of Lifestyle in the Treatment of Ankylosing Spondylitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05666115
• Other study ID #: EMLAS
• Status: Completed
• Phase: N/A
• Start date: January 2, 2023
• Est. completion date: June 10, 2023

Study information

• Verified date: June 2023
• Source: Camilo Jose Cela University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 10, 2023
• Est. primary completion date: June 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Autoimmune Diseases
• Collagen Diseases
• Rheumatic Diseases
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Dietary Supplement:
• Probiotic group
During the first 4 weeks, patients will be instructed to take two capsules of Enterelle plus (Bromatech lab, Manno, Switzerland) during morning time, before or after breakfast. Enterelle plus contains specific strains, i.e., S boulardi, E faecium, and acidophilus, that contribute to reduce the mycotic flora and modulate the gastrointestinal transit. For the next 8 weeks, participants will be told to ingest two capsules of Adomelle (Bromatech lab, Manno, Switzerland) at night, during or right after dinner. Adomelle contains several strains, including Bifidobacterium breve, that help to reduce abdominal fat, pain, and gas, and control the frequency of deposition

Other:
• Exercise group
This type of intervention has shown to benefit patients with several chronic conditions 23, including axSpA 13. Exercises combined high knees, lunges, basic burpees, plank, skipping, mountain climbers, and squats with jumps. The training routine will be conducted three times per week, and each session will last around 8 minutes (2 sets of 4 minutes, with a 10 second rest between them). All sessions will be individually tailored and supervised by a senior professional with a degree in Physiotherapy and Sciences of Physical Activity and Sport. Overall, participants will be told to continue exercising if low to moderate bearable pain appeared during training.

Locations

Country	Name	City	State
Spain	Elena Sonsoles Rodriguez Lopez	Arroyomolinos	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Camilo Jose Cela University

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be functional disability during daily life activities, evaluated with the Bath Ankylosing Spondylitis Functional Index.	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.	Change from Baseline BASFI at 4 and 12 weeks
Secondary	The secondary outcome will be disease activity during daily life activities, evaluated with the Bath Ankylosing Spondylitis Disease Activity Index.	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).	Change from Baseline BASDAI at 4 and 12 weeks
Secondary	Spinal mobility will be measured with the Bath Ankylosing Spondylitis Metrology Index (BASMI)	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".	Change from Baseline BASMI at 4 and 12 weeks
Secondary	The Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) 30 will be used to determine health-related quality of life	The ASQoL is valid, feasible and reliable. Total score range between 0 and 18, with higher scores indicating poorer quality of life.	Change from Baseline ASQoL at 4 and 12 weeks
Secondary	Biochemical measures (interleukin-1 (IL-1) and tumor necrosis factor a (TNFa))	A PeliKine compact enzyme-linked immunosorbent assay (ELISA) kit will be used to explore two inflammatory biomarkers	Change from Baseline biochemical measures at 4 and 12 weeks