NCT06669702Recruiting
EXercise Therapy in Axial SpA, Inflammation and Biologic Therapy (ExTASI-B)
EXercise As an Anti-inflammatory Treatment in Axial Spondyloarthritis (axSpA) for Patients Taking Biologic Therapy: a Proof of Concept Study (ExTASI-B).
Source: ClinicalTrials.gov · Last updated 5 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 30 Oct 2024
- Start date
- 1 Aug 2024
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Loughborough University
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT06669702
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Aug 2024 to the primary completion date, 30 Sept 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- 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.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals of Leicester NHS Trust Coordinator of this site? Confirm its status | Leicester | United Kingdom | Recruiting |
| Loughborough University, National Centre for Sport and Exercise Medicine Coordinator of this site? Confirm its status | Loughborough | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.