EXercise Therapy in Axial SpA, Inflammation and Biologic Therapy (ExTASI-B)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLoughborough University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Diagnosis of axSpA by a consultant rheumatologist
Age=/>18 years old
Without other significant cardiovascular comorbidities
Receiving stable dose biologic treatment
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
12-week home based exercise
BehavioralPatients 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.
Routine care
BehavioralParticipants 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.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: ExerciseExperimental treatment 1 intervention
Group C: Routine careExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Changes in spinal pain before (week 0 - baseline), and during (weeks 4, 8, and 12), the 12-week home based exercise intervention.
Using the validated visual analogue scale for spinal pain. The scale consists of a straight line with the end points defining extreme limits 'no spinal pain' and 'spinal pain as bad as it could be'. The line is 10cm in length (0cm point representing no pain, 10cm point representing pain as bad as it could be). A score of 0-10 is given depending on where the patient marks the line (5cm representing a score of 5). The higher the score, the worse the spinal pain.
Time frame
0, 4, 8, 12 weeks2
Changes in inflammatory monocyte phenotypes before (week 0 - baseline), and during (weeks 4, 8, and 12), the 12-week home based exercise intervention
Expression of receptors associated with inflammatory activity and stimulated cell inflammatory cytokine release. This will be analysed via flow cytometry.
Time frame
0, 4, 8, 12, weeks.3
Changes in ankylosing spondylitis disease activity before (week 0 - baseline), and during (weeks 4, 8, and 12), the 12-week home based exercise intervention.
Using the validated Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The BASDAI consists of a 0-10 score (0 being no problem and 10 being the worst problem) which is used to answer 6 questions on fatigue, spinal pain, joint pain, tenderness, morning stiffness duration, and morning stiffness severity. To give each symptom equal weighting, the mean (average) of the two scores relating to stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final 0 - 10 BASDAI score. The higher the score, the higher the activity of disease.
Time frame
0, 4, 8, 12, weeks.4
Changes in characteristics of T-cell cell phenotypes (senescence) before (week 0 - baseline), and during (weeks 4, 8, and 12), the 12-week home based exercise intervention
Expression of receptors associated with senescence. This will be analysed via flow cytometry
Time frame
0, 4, 8, 12, weeks.Secondary outcomes
1
Changes in tumor necrosis factor-alpha blood concentrations before (week 0 - baseline), and during (weeks 4, 8, and 12), the 12-week home based exercise intervention.
Time frame
0, 4, 8, 12, weeks2
Changes in interleukin-6 blood concentrations before (week 0 - baseline), and during (weeks 4, 8, and 12), the 12-week home based exercise intervention.
Time frame
0, 4, 8, 12, weeks3
Changes in stimulated cytokine concentration released from isolated Peripheral blood mononuclear cells (PBMCs) before (week 0 - baseline), and after (weeks 12), the 12-week home based exercise intervention.
PBMCs will be isolated using centrifuge and then cultured with PMA ionomycin to stimulate cytokine release. Concentrations of released inflammatory cytokines will be compared to a control culture (no PMA ionomycin stimulation).
Time frame
0,12, weeks4
Changes in the symptom burden of ankylosing spondylitis before (week 0 - baseline), and during (weeks 4, 8, and 12), the 12-week home based exercise intervention.
Using the validated Bath Ankylosing Spondylitis Functional Index (BASFI). The index assesses the functional limitation in patients with ankylosing spondylitis by asking the patient about symptom burden. The index consists of 10 questions evaluating how hard the patient finds situations i.e 'how difficult is it to put on your socks?' A score of 0 represents easy, and a score of 10 represents impossible. The mean (average) of the 10 questions is used to assign a symptom burden score of 0-10. The higher the score, the higher the symptom burden caused by ankylosing spondylitis.
Time frame
0, 4, 8, 12, weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Loughborough University
Lead sponsor
University Hospitals, Leicester
Collaborator
Source ClinicalTrials.gov