Tests walking exercise alongside biologic medicine in people with axial spondyloarthritis
Tests 12 weeks of home walking against usual care in adults with axial spondyloarthritis.
Key facts
- Who runs it
- Loughborough University
- Where
- Leicester and Loughborough, United KingdomSee the 2 sites
- Trial code
- Registry title
- EXercise Therapy in Axial SpA, Inflammation and Biologic Therapy (ExTASI-B)
- Status
- Recruiting
- People taking part
- 60 people, planned
- Started
- 1 Aug 2024
- Expected to end
- 31 Jul 2029
- Type of study
- Interventional, 3 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- 12-week home based exercise
- Routine care
- Record updated
- 5 November 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with axial spondyloarthritis who take a stable dose of a biologic medicine. It tests a 12-week home walking programme. Healthy adult volunteers also join as a comparison group.
- Age
- Patients: 18 years or older. Healthy volunteers: 18 to 65 years.
- Sex
- All sexes can join.
- Disease stage
- Axial spondyloarthritis (axSpA) diagnosed by a consultant rheumatologist, without other significant heart or blood vessel conditions.
- Earlier treatment
- Patients must be on a stable dose of biologic treatment. Healthy volunteers must not take long-term medicine that affects inflammation or the immune system.
Main reasons for not taking part
- Cannot exercise because of physical or psychological barriers, or exercise is not advised
- Hip or peripheral joint disease (patients)
- Very high physical activity score on the IPAQ
- Pregnant, breastfeeding, or planning pregnancy during the study
- Chronic anaemia (patients)
The registry criteria, word for word
Show all 28 criteriaShow less
Who can take part
- 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
- 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
Who cannot take part
- Presence of hip or peripheral joint disease
- 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
- 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
- Unable to undertake exercise due to physical or psychological barriers
- 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
- Co-morbidity that the research team determine to be a contraindication to involvement; Inclusion and exclusion criteria of healthy controls:
- 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:
- Musculoskeletal injury that affects one's ability to partake in physical activity
Where in United Kingdom
- University Hospitals of Leicester NHS TrustLeicester, United KingdomContact: Arumugam Moorthy, DrTaking people
- Loughborough University, National Centre for Sport and Exercise MedicineLoughborough, United KingdomContact: Nicolette C Bishop, PhDTaking people
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
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.
The 3 groups in the trial
- ControlNo study treatment, for comparison
Healthy controls
- ExerciseTreatment being tested
12-weeks of home based exercise involving 30 minutes of brisk walking on 5 days per week.
Treatment: 12-week home based exercise
- Routine careTreatment being tested
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- EXercise As an Anti-inflammatory Treatment in Axial Spondyloarthritis (axSpA) for Patients Taking Biologic Therapy: a Proof of Concept Study (ExTASI-B).
- Plain-language title
- Tests walking exercise alongside biologic medicine in people with axial spondyloarthritisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 5 November 2024