EXercise Therapy in Axial SpA, Inflammation and Biologic Therapy (ExTASI-B)

NCT06669702 | Recruiting DMC

• 1 other identifier: IRAS project ID: 333667
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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

Axial Spondyloarthrithis; Inflammatory Diseases; Arthritis

Keywords

Exercise; Inflammation; Immunosenescence

Outcome Measures

Primary Outcomes (4)

• Changes in spinal pain before (week 0 - baseline), and during (weeks 4, 8, and 12), the 12-week home based exercise intervention.

  Using the validated visual analogue scale for spinal pain. The scale consists of a straight line with the end points defining extreme limits 'no spinal pain' and 'spinal pain as bad as it could be'. The line is 10cm in length (0cm point representing no pain, 10cm point representing pain as bad as it could be). A score of 0-10 is given depending on where the patient marks the line (5cm representing a score of 5). The higher the score, the worse the spinal pain.

  0, 4, 8, 12 weeks

• Changes in inflammatory monocyte phenotypes before (week 0 - baseline), and during (weeks 4, 8, and 12), the 12-week home based exercise intervention

  Expression of receptors associated with inflammatory activity and stimulated cell inflammatory cytokine release. This will be analysed via flow cytometry.

  0, 4, 8, 12, weeks.

• Changes in ankylosing spondylitis disease activity before (week 0 - baseline), and during (weeks 4, 8, and 12), the 12-week home based exercise intervention.

  Using the validated Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The BASDAI consists of a 0-10 score (0 being no problem and 10 being the worst problem) which is used to answer 6 questions on fatigue, spinal pain, joint pain, tenderness, morning stiffness duration, and morning stiffness severity. To give each symptom equal weighting, the mean (average) of the two scores relating to stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final 0 - 10 BASDAI score. The higher the score, the higher the activity of disease.

  0, 4, 8, 12, weeks.

• Changes in characteristics of T-cell cell phenotypes (senescence) before (week 0 - baseline), and during (weeks 4, 8, and 12), the 12-week home based exercise intervention

  Expression of receptors associated with senescence. This will be analysed via flow cytometry

  0, 4, 8, 12, weeks.

Secondary Outcomes (24)

• Changes in tumor necrosis factor-alpha blood concentrations before (week 0 - baseline), and during (weeks 4, 8, and 12), the 12-week home based exercise intervention.

  0, 4, 8, 12, weeks

• Changes in interleukin-6 blood concentrations before (week 0 - baseline), and during (weeks 4, 8, and 12), the 12-week home based exercise intervention.

  0, 4, 8, 12, weeks

• Changes in stimulated cytokine concentration released from isolated Peripheral blood mononuclear cells (PBMCs) before (week 0 - baseline), and after (weeks 12), the 12-week home based exercise intervention.

  0,12, weeks

• Changes in the symptom burden of ankylosing spondylitis before (week 0 - baseline), and during (weeks 4, 8, and 12), the 12-week home based exercise intervention.

  0, 4, 8, 12, weeks.

• Changes in work productivity before (week 0 - baseline), and during (weeks 4, 8, and 12), the 12-week home based exercise intervention.

  0, 4, 8, 12, weeks.

Study Arms (3)

Control

NO INTERVENTION

Healthy controls

Exercise

EXPERIMENTAL

12-weeks of home based exercise involving 30 minutes of brisk walking on 5 days per week.

Behavioral: 12-week home based exercise

Routine care

EXPERIMENTAL

Routine care

Behavioral: Routine care

Interventions

12-week home based exercise BEHAVIORAL

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.

Exercise

Routine care BEHAVIORAL

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.

Routine care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to undertake exercise due to physical or psychological barriers
• 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
• 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
• 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)

Sponsors & Collaborators

• Loughborough University: lead
• University Hospitals, Leicester: collaborator

Study Sites (2)

Loughborough University, National Centre for Sport and Exercise Medicine

Loughborough, Leicestershire, LE113TU, United Kingdom

RECRUITING

University Hospitals of Leicester NHS trust

Leicester, United Kingdom, LE15WW, United Kingdom

RECRUITING

Related Publications (11)

• 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.

  PMID: 38854418 BACKGROUND

• 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.

  PMID: 29225811 BACKGROUND

• 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.

  PMID: 28391394 BACKGROUND

• 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.

  PMID: 24700875 BACKGROUND

• 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.

  PMID: 21818123 BACKGROUND

• 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.

  PMID: 28860095 BACKGROUND

• 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.

  PMID: 20188719 BACKGROUND

• 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.

  PMID: 3678222 BACKGROUND

• 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.

  PMID: 31736354 BACKGROUND

• 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.

  PMID: 35014114 BACKGROUND

• Schafer JL. Multiple imputation: a primer. Stat Methods Med Res. 1999 Mar;8(1):3-15. doi: 10.1177/096228029900800102.

  PMID: 10347857 BACKGROUND

MeSH Terms

Conditions

Arthritis; Motor Activity; Inflammation

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arumugam Moorthy, Dr

  University Hospitals, Leicester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolette C Bishop, PhD

CONTACT

01509226385; N.C.Bishop@lboro.ac.uk

Matthew J Roberts, PhD

CONTACT

M.Roberts3@lboro.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Random allocation into either a control group or an exercise group (12-weeks of home based exercise).

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 1, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): July 31, 2029
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)