Exercise Therapy in Patients With Axial Spondyloarthritis

NCT ID: NCT04368494

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2022-12-10

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.

Conditions

Axial Spondyloarthritis; Inflammatory Disease; Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control

Continue with normal activity.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Exercise

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

Group Type: EXPERIMENTAL

12-week home based exercise

Intervention Type: 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 RPE 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.

Interventions

12-week home based exercise

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 RPE 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals, Leicester

OTHER

Sponsor Role: collaborator

Loughborough University

OTHER

Sponsor Role: lead

Responsible Party

Nicolette Bishop

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arumugam Moorthy, Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospitals, Leicester

Locations

University Hospitals of Leicester NHS trust

Leicester, , United Kingdom

Loughborough University, National Centre for Sport and Exercise Medicine

Loughborough, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 38854418 (View on PubMed)

Other Identifiers

IRAS project ID: 268333

Identifier Type: -

Identifier Source: org_study_id