NCT06669702: ExTASI-B

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

Recruiting now NA Last updated 5 November 2024

What this trial tests

NA trial testing 12-week home based exercise in Axial Spondyloarthrithis in 60 participants. Currently enrolling.

Timeline

1 August 2024

Primary endpoint
30 September 2027

31 July 2029

Quick facts

Lead sponsor	Loughborough University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	60
Start date	1 August 2024
Primary completion	30 September 2027
Estimated completion	31 July 2029
Sites	2 locations across United Kingdom

Drugs / interventions tested

• 12-week home based exercise
• Routine care

Conditions studied

• Axial Spondyloarthrithis — all drugs for Axial Spondyloarthrithis →
• Inflammatory Diseases — all drugs for Inflammatory Diseases →
• Arthritis — all drugs for Arthritis →

Sponsor

Loughborough University

Who can join

18 and older, any sex, with Axial Spondyloarthrithis or Inflammatory Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.