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New treatment option for Axial Spondyloarthrithis
Official title EXercise Therapy in Axial SpA, Inflammation and Biologic Therapy (ExTASI-B)
ClinicalTrials.gov ID: NCT06669702
What this study is testing
- What it's testing
- 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 therapy for people living with axial spondyloarthritis and taking biologic medications to further improve their quality of life and lower their symptoms and disease burden. The main questions it aims to answer are: Does a 12-week structured home-based aerobic exercise intervention have a favourable effect on markers of immune-mediated inflammation and symptom severity?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Loughborough, Leicestershire, United Kingdom
- Leicester, United Kingdom, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Loughborough, Leicestershire, United Kingdom; Leicester, United Kingdom, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.