Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06669702

EXercise As an Anti-inflammatory Treatment in Axial Spondyloarthritis (axSpA) for Patients Taking Biologic Therapy: a Proof of Concept Study (ExTASI-B)

Led by Loughborough University · Updated on 2024-11-05

60

Participants Needed

2

Research Sites

95 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

Researchers are evaluating the effects of a 12-week home-based aerobic exercise program on people living with axial spondyloarthritis (axSpA) who are receiving biologic medications. This randomized controlled trial aims to determine whether brisk walking can improve quality of life, reduce symptoms, and lower markers of immune-mediated inflammation. The study also compares data from axSpA patients with a healthy control group to better understand these effects. Participants in the exercise group will be asked to perform 30 minutes of brisk walking five days a week at a moderate intensity for 12 weeks, using a wrist-worn activity monitor to track heart rate and activity. They will visit the study site every four weeks for blood samples and questionnaires. The usual care group will continue their normal care routine and attend the same visits for assessments. Healthy controls will provide baseline comparisons. Throughout the study, researchers will monitor changes in spinal pain, disease activity, immune cell types, and various inflammatory markers at baseline and at weeks 4, 8, and 12. Additional assessments include quality of life, physical function, exercise capacity, body composition, symptom burden, work productivity, sleep quality, and medication adherence. The study will last 12 weeks, with regular evaluations to understand the impact of the exercise intervention.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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 demands 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
Not Eligible

You will not qualify if you...

  • Unable to undertake exercise due to physical or psychological barriers
  • Presence of hip or peripheral joint disease
  • Contraindication to exercise training as per guidelines
  • Excessively active (high score on IPAQ)
  • Unable to communicate sufficiently in English
  • Female participants who are pregnant, lactating, or planning pregnancy during the study
  • Inability to give informed consent or comply with protocol
  • Presence of chronic anaemia below specified hemoglobin or hematocrit levels
  • Co-morbidity contraindicating involvement
  • Healthy controls with immune system disorders, cardiovascular or cardiometabolic diseases, chronic health conditions affecting physical activity, or musculoskeletal injuries affecting physical activity
  • Healthy controls unable to undertake exercise or excessively active
  • Healthy controls unable to communicate sufficiently in English
  • Healthy controls who are pregnant, lactating, or planning pregnancy during the study
  • Healthy controls unable to give informed consent or comply with protocol
  • Healthy controls with any of the specified health issues mentioned above in exclusion criteria for healthy controls
  • Healthy controls with musculoskeletal injury affecting physical activity ability
  • Healthy controls excessively active (high IPAQ score) or unable to undertake exercise due to barriers
  • Healthy controls unable to communicate in English sufficiently
  • Healthy controls pregnant, lactating, or planning pregnancy during the study
  • Healthy controls unable to give informed consent or comply with study requirements
  • Healthy controls with diagnosed or aware of immune, cardiovascular, metabolic, or chronic conditions affecting physical activity or musculoskeletal injury

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants are assigned to either a 12-week home-based walking exercise program or routine care with exercise diaries, while continuing their biologic therapy. The exercise program involves 30 minutes of brisk walking on 5 days per week.

Visits at baseline, week 4, week 8, and week 12 for assessments

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

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Research Team

N

Nicolette C Bishop, PhD

M

Matthew J Roberts, PhD

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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Published Research Related To This Trial

Lifelong training improves anti-inflammatory environment and maintains the number of regulatory T cells in masters athletes.

Luciele G Minuzzi, Luis Rama, Nicolette C Bishop...

https://pubmed.ncbi.nlm.nih.gov/28391394

The anti-inflammatory effects of exercise: mechanisms and implications for the prevention and treatment of disease.

Michael Gleeson, Nicolette C Bishop, David J Stensel...

https://pubmed.ncbi.nlm.nih.gov/21818123

Effectiveness of Exercise Programs in Ankylosing Spondylitis: A Meta-Analysis of Randomized Controlled Trials.

Virginie Pécourneau, Yannick Degboé, Thomas Barnetche...

https://pubmed.ncbi.nlm.nih.gov/28860095

Influence of acute moderate- to high-intensity aerobic exercise on markers of immune function and microparticles in renal transplant recipients.

Patrick J Highton, Alice E M White, Daniel G D Nixon...

https://pubmed.ncbi.nlm.nih.gov/31736354