At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- Mix of remote tasks and in-person visits
- Drug or intervention
- 12-week home based exercise (behavioural), Routine care (behavioural)
- How long the study runs
- Study runs about 59 months (dates as stated)
- About the drug or intervention
- 12-week home based exercise — behavioural: Patients allocated to the exercise arm will be prescribed a home-based walking exercise programme consisting of 30 minutes of walking on 5 days per week at an rating of perceived exertion in the range of 12-14 (somewhat hard). · Routine care — behavioural: Participants in this group will continue with their current routine care and will be given a diary of exercises that they can do, which are usually given to them as part of their health care routine by physiotherapists or consultants.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 60
- Started
- 2024-08-01
- Last checked
- 2024-11
Plain English Summary
What is this study?
- • Testing a new treatment for axial spondyloarthrithis
- • NA - 60 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with axial spondyloarthrithis
Where?
- • Loughborough - Loughborough University, National Centre for Sport and Exercise Medicine
- • Leicester - University Hospitals of Leicester NHS trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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 health, anthropometrical measures, and immune markers that associate with systemic inflammation. * The effect of the home-based intervention on objective measures of physical function and exercise tolerance The study will compare the data of a healthy group with that of people living with axial spondyloarthritis. Within the patient population, 20 of the individuals will be allocated to the exercise group (randomly), and 20 will be allocated to the usual care group. In the exercise group, participants will be asked to do 30 minutes of brisk walking five days a week for 12 weeks, and they will be visiting Loughborough University every four weeks to provide blood samples and fill out questionnaires. Participants in the usual care group will continue with their current care routine and will visit the study site to provide blood samples and questionnaire data every 4 weeks. The data from all axSpA patients will be compared to healthy controls, and subgroup analysis will be conducted to investigate the difference between the exercise group and the usual care group.
More detail
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 spondyloarthritis (axSpA), with the potential to both promote well-being, increase flexibility and range of movement, improve posture and reduce stiffness and pain. axSpA is an inflammatory arthritis and raised levels of indicators ('markers') of this inflammatory process (e.g. CRP) can be detected in the blood of patients. These markers are released as a consequence of the condition, but some, such as TNF-alpha and interleukin-17 (IL-17), also promote further disease development. In other inflamed patient groups we have shown that regular exercise (brisk walking) can lower the levels of these pro-inflammatory markers in the blood and increase levels of anti-inflammatory markers, independently of weight loss. Despite axSpA being an inflammatory condition with prescribed medication focused on reducing inflammation there are no studies that have assessed the potential of exercise to act as an anti-inflammatory adjuvant to biologic therapy in axSpA. This research will investigate the effect of 12 weeks of a home-based walking exercise intervention on measures of systemic inflammation and body composition, well-being and measures of disease activity using established and validated methods in 20 axSpA patients on regular biologic therapy and compare this group with 20 patients on regular biologic therapy who carry on with their standard care and normal levels of activity. Also, a baseline comparison will be conducted between a group of 20 healthy individuals and axSpA patients (40).This proof-of-concept study will determine the potential of exercise as an adjuvant anti-inflammatory treatment for patients with axSpA taking biologic medication.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Diagnosis of axSpA by a consultant rheumatologist
- ✓Age=/\>18 years old
- ✓Without other significant cardiovascular other health conditions
- ✓Receiving stable dose biologic treatment
- ✓Able to commit to the time demands of the study
Who cannot take part
- ✗Unable to undertake exercise due to physical or psychological barriers
- ✗Presence of hip or peripheral joint disease
- ✗safety concern to exercise training (American College of Sports Medicine guidelines)
- ✗Excessively active (score of high on IPAQ)
- ✗Unable to communicate sufficiently in English
See the full criteria
Where Is This Study? (2 UK sites)
Loughborough University, National Centre for Sport and Exercise Medicine
Loughborough LE113TU, United Kingdom
University Hospitals of Leicester NHS trust
Leicester LE15WW, United Kingdom
How to Get in Touch
Nicolette C Bishop, PhD
Sponsor contactCONTACT
Matthew J Roberts, PhD
Sponsor contactCONTACT