EXercise Therapy in Axial SpA, Inflammation and Biologic Therapy (ExTASI-B)
NCT ID: NCT06669702
Last Updated: 2024-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-08-01
2029-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Control
Healthy controls
No interventions assigned to this group
Exercise
12-weeks of home based exercise involving 30 minutes of brisk walking on 5 days per week.
12-week home based exercise
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). Each patient's heart rate range will be established during the baseline exercise test by recording the heart rate response at the required RPE target range. This will be provided to each patient to use in conjunction with the activity monitor they will be given to wear on their non-dominant wrist. The monitor reports heart rate and records daily steps, distance and activity duration.
Participants can break down the exercise time in a way that suits their time, i.e., they can do 3 × 10 minutes, 2 × 15 minutes, etc.
Routine care
Routine care
Routine care
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. The diary has information about yoga-like stretching practices.
Interventions
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12-week home based exercise
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). Each patient's heart rate range will be established during the baseline exercise test by recording the heart rate response at the required RPE target range. This will be provided to each patient to use in conjunction with the activity monitor they will be given to wear on their non-dominant wrist. The monitor reports heart rate and records daily steps, distance and activity duration.
Participants can break down the exercise time in a way that suits their time, i.e., they can do 3 × 10 minutes, 2 × 15 minutes, etc.
Routine care
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. The diary has information about yoga-like stretching practices.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
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
18 Years
ALL
Yes
Sponsors
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University Hospitals, Leicester
OTHER
Loughborough University
OTHER
Responsible Party
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Nicolette Bishop
Professor
Principal Investigators
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Arumugam Moorthy, Dr
Role: PRINCIPAL_INVESTIGATOR
University Hospitals, Leicester
Locations
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Loughborough University, National Centre for Sport and Exercise Medicine
Loughborough, Leicestershire, United Kingdom
University Hospitals of Leicester NHS trust
Leicester, United Kingdom, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Clare Stevinson, PhD
Role: backup
Sepehr Qooja, MSc
Role: backup
References
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Roberts MJ, Hamrouni M, Linsley V, Moorthy A, Bishop NC. Exercise as an anti-inflammatory Therapy in Axial Spondyloarthritis Therapeutic Intervention (EXTASI) study: a randomized controlled trial. Rheumatol Adv Pract. 2024 May 11;8(2):rkae062. doi: 10.1093/rap/rkae062. eCollection 2024.
Dungey M, Young HML, Churchward DR, Burton JO, Smith AC, Bishop NC. Regular exercise during haemodialysis promotes an anti-inflammatory leucocyte profile. Clin Kidney J. 2017 Dec;10(6):813-821. doi: 10.1093/ckj/sfx015. Epub 2017 Mar 27.
Minuzzi LG, Rama L, Bishop NC, Rosado F, Martinho A, Paiva A, Teixeira AM. Lifelong training improves anti-inflammatory environment and maintains the number of regulatory T cells in masters athletes. Eur J Appl Physiol. 2017 Jun;117(6):1131-1140. doi: 10.1007/s00421-017-3600-6. Epub 2017 Apr 8.
Viana JL, Kosmadakis GC, Watson EL, Bevington A, Feehally J, Bishop NC, Smith AC. Evidence for anti-inflammatory effects of exercise in CKD. J Am Soc Nephrol. 2014 Sep;25(9):2121-30. doi: 10.1681/ASN.2013070702. Epub 2014 Apr 3.
Gleeson M, Bishop NC, Stensel DJ, Lindley MR, Mastana SS, Nimmo MA. The anti-inflammatory effects of exercise: mechanisms and implications for the prevention and treatment of disease. Nat Rev Immunol. 2011 Aug 5;11(9):607-15. doi: 10.1038/nri3041.
Pecourneau V, Degboe Y, Barnetche T, Cantagrel A, Constantin A, Ruyssen-Witrand A. Effectiveness of Exercise Programs in Ankylosing Spondylitis: A Meta-Analysis of Randomized Controlled Trials. Arch Phys Med Rehabil. 2018 Feb;99(2):383-389.e1. doi: 10.1016/j.apmr.2017.07.015. Epub 2017 Aug 30.
Beavers KM, Brinkley TE, Nicklas BJ. Effect of exercise training on chronic inflammation. Clin Chim Acta. 2010 Jun 3;411(11-12):785-93. doi: 10.1016/j.cca.2010.02.069. Epub 2010 Feb 25.
Borg G, Hassmen P, Lagerstrom M. Perceived exertion related to heart rate and blood lactate during arm and leg exercise. Eur J Appl Physiol Occup Physiol. 1987;56(6):679-85. doi: 10.1007/BF00424810.
Highton PJ, White AEM, Nixon DGD, Wilkinson TJ, Neale J, Martin N, Bishop NC, Smith AC. Influence of acute moderate- to high-intensity aerobic exercise on markers of immune function and microparticles in renal transplant recipients. Am J Physiol Renal Physiol. 2020 Jan 1;318(1):F76-F85. doi: 10.1152/ajprenal.00332.2019. Epub 2019 Nov 18.
Billany RE, Smith AC, Stevinson C, Clarke AL, Graham-Brown MPM, Bishop NC. Perceived barriers and facilitators to exercise in kidney transplant recipients: A qualitative study. Health Expect. 2022 Apr;25(2):764-774. doi: 10.1111/hex.13423. Epub 2022 Jan 10.
Schafer JL. Multiple imputation: a primer. Stat Methods Med Res. 1999 Mar;8(1):3-15. doi: 10.1177/096228029900800102.
Other Identifiers
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IRAS project ID: 333667
Identifier Type: -
Identifier Source: org_study_id
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