Exercise therapy for people with axial spondyloarthritis
EXercise As an Anti-inflammatory Treatment in Axial Spondyloarthritis (axSpA) for Patients Taking Biologic Therapy: a Proof of Concept Study (ExTASI-B).
This study is testing if a 12-week home-based walking program can help people with axial spondyloarthritis feel better and improve their overall health while they are already on medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Loughborough University Academic / other |
| Locations | 2 sites (Loughborough, Leicestershire and 1 other locations) |
| Trial ID | NCT06669702 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of a 12-week structured home-based aerobic exercise program on individuals with axial spondyloarthritis who are already receiving biologic therapy. The study aims to determine if brisk walking can improve quality of life, reduce symptoms, and lower markers of immune-mediated inflammation. Additionally, it will assess the acceptability of the intervention through participant feedback and evaluate its impact on cardiometabolic health and body composition. The trial will involve 40 participants, with half receiving the exercise intervention and the other half continuing routine care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with axial spondyloarthritis who are stable on biologic treatment.
Not a fit: Patients unable to exercise due to physical or psychological barriers or those with significant cardiovascular comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance the quality of life and reduce disease burden for patients with axial spondyloarthritis.
How similar studies have performed: Previous studies have shown that exercise can lower inflammatory markers in other patient groups, suggesting potential success for this approach in axial spondyloarthritis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of axSpA by a consultant rheumatologist * Age=/\>18 years old * Without other significant cardiovascular comorbidities * Receiving stable dose biologic treatment * Able to commit to the time demands of the study Exclusion Criteria: * Unable to undertake exercise due to physical or psychological barriers * Presence of hip or peripheral joint disease * Contraindication to exercise training (American College of Sports Medicine guidelines) * Excessively active (score of high on IPAQ) * Unable to communicate sufficiently in English * Female participants who are pregnant, lactating, or planning pregnancy during the course of the study. * Inability to give informed consent or comply with testing and training protocol for any reason. * Presence of chronic anaemia (haemoglobin less than 13.5 g/dL for men; less than 12.0 g/dL for women; or haematocrit less than 41.0% in men, less than 36.0% in women. * Co-morbidity that the research team determine to be a contraindication to involvement Inclusion and exclusion criteria of healthy controls: Inclusion Criteria: * Aged between 18 years old and 65 years old * Not taking any long-term medication that affects inflammation or immune-mediated inflammation. * Free from infection or infection symptoms Exclusion criteria: The participant may not enter the study if ANY of the following apply: * Unable to undertake exercise due to physical or psychological barriers * Excessively active (score of high on IPAQ) * Unable to communicate sufficiently in English * Female participants who are pregnant, lactating, or planning pregnancy during the course of the study. * Inability to give informed consent or comply with testing and training protocol for any reason. * Have been diagnosed with or are aware of at least one of the following health issues: * Immune system disorder * Cardiovascular and/or cardiometabolic diseases, including but not limited to high blood pressure, high triglycerides and/or cholesterol levels, diabetes mellitus, etc. * Any chronic health condition that affects one's ability to partake in physical activity * Musculoskeletal injury that affects one's ability to partake in physical activity
Where this trial is running
Loughborough, Leicestershire and 1 other locations
- Loughborough University, National Centre for Sport and Exercise Medicine — Loughborough, Leicestershire, United Kingdom (Recruiting)
- University Hospitals of Leicester NHS trust — Leicester, United Kingdom, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Arumugam Moorthy, Dr — University Hospitals, Leicester
- Study coordinator: Nicolette C Bishop, PhD
- Email: N.C.Bishop@lboro.ac.uk
- Phone: 01509226385
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.