Actively Recruiting
EXercise Therapy in Axial SpA, Inflammation and Biologic Therapy (ExTASI-B)
Led by Loughborough University · Updated on 2024-11-05
60
Participants Needed
2
Research Sites
260 weeks
Total Duration
On this page
Sponsors
L
Loughborough University
Lead Sponsor
U
University Hospitals, Leicester
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
EXercise Therapy in Axial SpA, Inflammation and Biologic Therapy (ExTASI-B)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of axial spondyloarthritis by a consultant rheumatologist
- Age 18 years or older
- No significant cardiovascular comorbidities
- Receiving a stable dose of biologic treatment
- Able to commit to the time requirements of the study
- Healthy controls aged between 18 and 65 years
- Healthy controls not taking long-term medication affecting inflammation
- Healthy controls free from infection or infection symptoms
You will not qualify if you...
- Unable to undertake exercise due to physical or psychological barriers
- Presence of hip or peripheral joint disease
- Contraindications to exercise training as per American College of Sports Medicine guidelines
- Excessively active individuals (high score on IPAQ)
- Unable to communicate sufficiently in English
- Female participants who are pregnant, lactating, or planning pregnancy during the study
- Unable to give informed consent or comply with study protocols
- Presence of chronic anaemia (low hemoglobin or hematocrit levels)
- Co-morbidities deemed contraindications by the research team
- Healthy controls with immune system disorders
- Healthy controls with cardiovascular or cardiometabolic diseases, including high blood pressure, high triglycerides or cholesterol, or diabetes mellitus
- Healthy controls with chronic health conditions affecting physical activity
- Healthy controls with musculoskeletal injuries affecting physical activity
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Loughborough University, National Centre for Sport and Exercise Medicine
Loughborough, Leicestershire, United Kingdom, LE113TU
Actively Recruiting
2
University Hospitals of Leicester NHS trust
Leicester, United Kingdom, United Kingdom, LE15WW
Actively Recruiting
Research Team
N
Nicolette C Bishop, PhD
CONTACT
M
Matthew J Roberts, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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