💬In plain words
What the trial is, and whether it could suit you
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?
As a secondary aim and outcome, this study will investigate:
* The acceptability of this intervention using questionnaires with free text boxes and one-to-one semi-structured interviews in a subset (50%) of participants (Q-ExTASI-B substudy).
* The effect of the home-based intervention on circulating markers of cardiometabolic
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
💊
What it tests
- 12-week home based exercise
- Routine care
Loughborough University, National Centre for Sport and Exercise Medicine
Loughborough, United Kingdom
University Hospitals of Leicester NHS trust
Leicester, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
HealthTeky