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Exercise Therapy in Patients With Axial Spondyloarthritis (ExTASI)

L

Loughborough University

Status

Completed

Conditions

Arthritis
Axial Spondyloarthritis
Inflammatory Disease

Treatments

Behavioral: 12-week home based exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT04368494
IRAS project ID: 268333

Details and patient eligibility

About

Regular exercise, such as brisk walking, has been shown to lower levels of indicators of inflammation in the blood in people with long term conditions. This includes people with heart disease, kidney disease and diabetes. Axial Spondyloarthritis (axSpA) is an inflammatory condition with prescribed medication focusing on reducing inflammation. However, the effect of exercise on indicators of inflammation in axSpA is unknown.

The research study intends to investigate whether a 12-week period of regular exercise can have favourable effects on inflammatory markers in the blood.

Full description

Over 200,000 people in the UK have axial spondyloarthritis (axSpA). In 80% of cases the condition begins between 20-30 years of age. Exercise is encouraged as an essential treatment of axSpA, with the potential to promote well-being, flexibility, posture and pain management. Axial spondyloarthritis is an inflammatory arthritis and raised levels of indicators can be detected in the blood (e.g C-reactive protein). These markers are released as a consequence of the condition, but some, such as TNF-alpha, also promote further disease development.

In other patient groups with inflammatory diseases it has been demonstrated that regular exercise (brisk walking) can lower the levels of pro-inflammatory blood markers and increase levels of anti-inflammatory markers, independent of weight loss. Despite axSpA being an inflammatory condition with prescribed medication focused on reducing inflammation, there are no studies which have assessed the potential of exercise as an anti-inflammatory treatment in axSpA.

This research study will investigate the effect of 12 weeks of a home-based walking exercise intervention on measures of systemic inflammation and body composition. Measures of well-being and disease activity will also be investigated using established and validated methods. There will be an exercise and control group, both containing 10 participants. In the control group, patients will carry on with their normal activity. This proof-of-concept study will determine the potential of exercise as an additional anti-inflammatory treatment for patients with axSpA.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of Axial Spondyloarthritis by a consultant rheumatologist.
  • Without other significant cardiovascular comorbidities.
  • Receiving stable dose NSAID 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 International Physical Activity Questionnaire).
  • 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 the testing and training protocol for any reason.
  • Presence of chronic anaemia.
  • Co-morbidity that the research team determine to be a contraindication to involvement.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Control
No Intervention group
Description:
Continue with normal activity.
Exercise
Experimental group
Description:
12-weeks of home based exercise involving 30 minutes of brisk walking on 5 days per week.
Treatment:
Behavioral: 12-week home based exercise

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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