Status:

RECRUITING

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

Lead Sponsor:

Loughborough University

Collaborating Sponsors:

University Hospitals, Leicester

Conditions:

Axial Spondyloarthrithis

Inflammatory Diseases

Eligibility:

All Genders

18+ years

Phase:

NA

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 the...

Detailed Description

Over 200,000 people in the UK have axial spondyloarthritis. In 80% of cases the condition begins in the second or third decade of life. Exercise is encouraged as an essential treatment of axial spondy...

Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Inclusion and exclusion criteria of healthy controls:

Inclusion Criteria:

  • 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:

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

Key Trial Info

Start Date :

August 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 31 2029

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT06669702

Start Date

August 1 2024

End Date

July 31 2029

Last Update

November 5 2024

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Loughborough University, National Centre for Sport and Exercise Medicine

Loughborough, Leicestershire, United Kingdom, LE113TU

2

University Hospitals of Leicester NHS trust

Leicester, United Kingdom, United Kingdom, LE15WW

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