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RECRUITING

NCT06669702

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

Sponsor: Loughborough University

View on ClinicalTrials.gov

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 therapy for people living with axial spondyloarthritis and taking biologic medications to further improve their quality of life and lower their symptoms and disease burden. The main questions it aims to answer are: Does a 12-week structured home-based aerobic exercise intervention have a favourable effect on markers of immune-mediated inflammation and symptom severity? As a secondary aim and outcome, this study will investigate: * The acceptability of this intervention using questionnaires with free text boxes and one-to-one semi-structured interviews in a subset (50%) of participants (Q-ExTASI-B substudy). * The effect of the home-based intervention on circulating markers of cardiometabolic health, anthropometrical measures, and immune markers that associate with systemic inflammation. * The effect of the home-based intervention on objective measures of physical function and exercise tolerance The study will compare the data of a healthy group with that of people living with axial spondyloarthritis. Within the patient population, 20 of the individuals will be allocated to the exercise group (randomly), and 20 will be allocated to the usual care group. In the exercise group, participants will be asked to do 30 minutes of brisk walking five days a week for 12 weeks, and they will be visiting Loughborough University every four weeks to provide blood samples and fill out questionnaires. Participants in the usual care group will continue with their current care routine and will visit the study site to provide blood samples and questionnaire data every 4 weeks. The data from all axSpA patients will be compared to healthy controls, and subgroup analysis will be conducted to investigate the difference between the exercise group and the usual care group.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-08-01

Completion Date

2029-07-31

Last Updated

2024-11-05

Healthy Volunteers

Yes

Conditions

Axial Spondyloarthrithis Inflammatory Diseases Arthritis

Interventions

BEHAVIORAL

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 rating of perceived exertion 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. Participants can break down the exercise time in a way that suits their time, i.e., they can do 3 × 10 minutes, 2 × 15 minutes, etc.

BEHAVIORAL

Routine care

Participants in this group will continue with their current routine care and will be given a diary of exercises that they can do, which are usually given to them as part of their health care routine by physiotherapists or consultants. The diary has information about yoga-like stretching practices.

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

Locations (2)

Loughborough University, National Centre for Sport and Exercise Medicine

Loughborough, Leicestershire, United Kingdom

University Hospitals of Leicester NHS trust

Leicester, United Kingdom, United Kingdom