Clinical trial NCT04368494: Exercise Therapy in Patients With Axial Spondyloarthritis
Official title: Exercise as an Anti-inflammatory Treatment in Axial Spondyloarthritis Patients (axSpA): a Proof of Concept Study (ExTASI).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Axial Spondyloarthritis
Inflammatory Disease
Arthritis
Keywords: Exercise
Lead sponsor: Loughborough University
Sponsor class: OTHER
Collaborators: name: University Hospitals, Leicester
First posted: 2020-04-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Random allocation into either a control group or an exercise group (12-weeks of home based exercise).
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in interleukin-6 blood concentrations before (week 0 - baseline), during (weeks 4, 8, and 12), and after (week 20) the 12-week home based exercise intervention.
timeFrame: 0, 4, 8, 12, 20 weeks.
measure: Changes in tumor necrosis factor-alpha blood concentrations before (week 0 - baseline), during (weeks 4, 8, and 12), and after (week 20) the 12-week home based exercise intervention.
timeFrame: 0, 4, 8, 12, 20 weeks.
measure: Changes in interleukin-10 blood concentrations before (week 0 - baseline), during (weeks 4, 8, and 12), and after (week 20) the 12-week home based exercise intervention.
timeFrame: 0, 4, 8, 12, 20 weeks.
measure: Changes in c-reactive protein blood concentrations before (week 0 - baseline), during (weeks 4, 8, and 12), and after (week 20) the 12-week home based exercise intervention.
timeFrame: 0, 4, 8, 12, 20 weeks.
Secondary outcomes:
measure: Changes in creatine kinase blood concentrations before (week 0 - baseline), during (weeks 4, 8, and 12), and after (week 20) the 12-week home based exercise intervention.
timeFrame: 0, 4, 8, 12, 20 weeks.
measure: Changes in inflammatory immune cell phenotypes before (week 0 - baseline), during (weeks 4, 8, and 12), and after (week 20) the 12-week home based exercise intervention.
timeFrame: 0, 4, 8, 12, 20 weeks.
measure: Changes in ankylosing spondylitis disease activity before (week 0 - baseline), during (weeks 4, 8, and 12), and after (week 20) the 12-week home based exercise intervention.
timeFrame: 0, 4, 8, 12, 20 weeks.
measure: Changes in the symptom burden of ankylosing spondylitis before (week 0 - baseline), during (weeks 4, 8, and 12), and after (week 20) the 12-week home based exercise intervention.
timeFrame: 0, 4, 8, 12, 20 weeks.
measure: Changes in spinal pain before (week 0 - baseline), during (weeks 4, 8, and 12), and after (week 20) the 12-week home based exercise intervention.
timeFrame: 0, 4, 8, 12, 20 weeks.
measure: Changes in overall health status before (week 0 - baseline), during (weeks 4, 8, and 12), and after (week 20) the 12-week home based exercise intervention.
timeFrame: 0, 4, 8, 12, 20 weeks.
measure: Changes in work productivity before (week 0 - baseline), during (weeks 4, 8, and 12), and after (week 20) the 12-week home based exercise intervention.
timeFrame: 0, 4, 8, 12, 20 weeks.
measure: Sedentary activity minutes per day
timeFrame: 7 days (+/- 3 days) in the 2 week period prior to baseline assessment.
measure: Light physical activity minutes per day
timeFrame: 7 days (+/- 3 days) in the 2 week period prior to baseline assessment.
measure: Moderate to vigorous physical activity minutes per day
timeFrame: 7 days (+/- 3 days) in the 2 week period prior to baseline assessment.
measure: Changes in subjective physical activity before (week 0 - baseline), during (week 12), and after (week 20) the 12-week home based exercise intervention.
timeFrame: 0, 12 and 20 weeks.
measure: Changes in exercise tolerance before (week 0 - baseline), during (week 12), and after (week 20) the 12-week home based exercise intervention.
timeFrame: 0, 12 and 20 weeks.
measure: Changes in physical function before (week 0 - baseline), during (week 12), and after (week 20) the 12-week home based exercise intervention.
timeFrame: 0, 12 and 20 weeks.
measure: Changes in secondary physical function before (week 0 - baseline), during (week 12), and after (week 20) the 12-week home based exercise intervention.
timeFrame: 0, 12 and 20 weeks.
measure: Changes in height before (week 0 - baseline), during (weeks 4, 8, and 12), and after (week 20) the 12-week home based exercise intervention.
timeFrame: 0, 4, 8, 12, 20 weeks.
measure: Changes in weight before (week 0 - baseline), during (weeks 4, 8, and 12), and after (week 20) the 12-week home based exercise intervention.
timeFrame: 0, 4, 8, 12, 20 weeks.
measure: Changes in waist circumference before (week 0 - baseline), during (weeks 4, 8, and 12), and after (week 20) the 12-week home based exercise intervention.
timeFrame: 0, 4, 8, 12, 20 weeks.
measure: Changes in hip circumference before (week 0 - baseline), during (weeks 4, 8, and 12), and after (week 20) the 12-week home based exercise intervention.
timeFrame: 0, 4, 8, 12, 20 weeks.
measure: Changes in systolic blood pressure before (week 0 - baseline), during (weeks 4, 8, and 12), and after (week 20) the 12-week home based exercise intervention.
timeFrame: 0, 4, 8, 12, 20 weeks.
measure: Changes in diastolic blood pressure before (week 0 - baseline), during (weeks 4, 8, and 12), and after (week 20) the 12-week home based exercise intervention.
timeFrame: 0, 4, 8, 12, 20 weeks.
measure: Changes in body fat percentage before (week 0 - baseline), during (weeks 4, 8, and 12), and after (week 20) the 12-week home based exercise intervention.
timeFrame: 0, 4, 8, 12, 20 weeks.
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS trust
city: Loughborough
country: United Kingdom
facility: Loughborough University, National Centre for Sport and Exercise Medicine
Study officials:
affiliation: University Hospitals, Leicester
name: Arumugam Moorthy, Dr
role: PRINCIPAL_INVESTIGATOR
References: