Status:
RECRUITING
EXercise Therapy in Axial SpA, Inflammation and Biologic Therapy (ExTASI-B)
Lead Sponsor:
Loughborough University
Collaborating Sponsors:
University Hospitals, Leicester
Conditions:
Axial Spondyloarthrithis
Inflammatory Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this randomised controlled trial study is to investigate whether exercise (brisk walking, equal to 13 on a rating of perceived exertion scale; somewhat hard) can be used as an adjuvant the...
Detailed Description
Over 200,000 people in the UK have axial spondyloarthritis. In 80% of cases the condition begins in the second or third decade of life. Exercise is encouraged as an essential treatment of axial spondy...
Eligibility 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
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06669702
Start Date
August 1 2024
End Date
July 31 2029
Last Update
November 5 2024
Active Locations (2)
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1
Loughborough University, National Centre for Sport and Exercise Medicine
Loughborough, Leicestershire, United Kingdom, LE113TU
2
University Hospitals of Leicester NHS trust
Leicester, United Kingdom, United Kingdom, LE15WW