NCT05666115

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Camilo Jose Cela University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthritis
• Rheumatic Diseases
• Autoimmune Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-01-02
• Primary completion: 2023-06-10
• Completion: 2023-06-10
• First posted: 2022-12-27
• Last updated: 2023-06-15

Locations

1 site across 1 country: Spain