Randomised controlled trial to investigate the effectiveness of online exercise interventions in reducing fatigue and the high burden of mental health symptoms in rheumatology patients.

Background Systemic autoimmune rheumatic diseases (SARDs) are incurable and have adverse impacts on multiple areas of patient lives. Treatment is largely pharmacological to suppress the immune system and side effects are common. The symptoms that patients report as the most life-changing (particularly fatigue) currently have limited pharmacological treatments and are rarely considered as a justification for treatment. The NHS and clinicians are under immense pressures, and patients and clinicians in our previous studies reported very limited holistic support for these life-changing symptoms. The onus is therefore on developing and trialling non-pharmacological interventions that can then be offered to SARD – and other chronic disease – patients to help improve their lives. We carried out a feasibility trial of multiple interventions to assess acceptability and feasibility, and online exercise classes scored highly. We are therefore proposing progression to a larger scale trial to assess effectiveness. Aims and objectives To assess the effectiveness of online instructor-led group exercise (Pilates or Tai Chi) classes for rheumatology patients compared to usual care, with specific objectives including to: Measure the effectiveness of online exercise courses for reducing fatigue (primary outcome), and improving QoL, depression, resilience, and disease adapting (secondary outcomes) among rheumatology patients. Evaluate the cost and cost-effectiveness of online classes. Ascertain participant views and experiences of the two types of online exercise classes (Pilates and Tai Chi). Assess sustainability of continuation of increased physical activity following the initial 8 week main intervention period. Methods This will be a three-armed assessor-blinded RCT comparing online exercise classes (Pilates or Tai Chi) to treatment as usual in adults with specified autoimmune rheumatic diseases. Online exercise classes will be twice per week, in 50-minute sessions, over 8 weeks via Zoom, in groups of 12-18. The target sample size is 420 (N=140 per-arm), based on 90% power in detecting a minimum 5-point difference in fatigue measurement (FACIT-F scores) at 6 months between the two exercise groups combined compared to the control group. Participants must be: aged 18 or over, able to provide informed consent, and provide written evidence (in the form of a copy of a clinic letter) of one of the following systemic autoimmune rheumatological disease diagnoses: Systemic lupus erythematosus (SLE), Sjögrens, systemic sclerosis, Undifferentiated and mixed connective tissue diseases (UCTD and MCTD), myositis or vasculitis. Participants will be recruited through rheumatology charities, disease support groups, and 3 rheumatology clinics, with a strategy to ensure equality of opportunity and diversity of participants. Surveys will be completed at baseline, 8 and 16 weeks, and 6 months post-baseline. Delivery and dissemination The duration of the trial will be 24 months. There will be a minimum of 3 main outputs generated that will be published in high-quality peer-reviewed journals. Target audiences for dissemination include: rheumatology charities, rheumatology patients, the academic community; commissioners, policy-makers, clinicians, professional bodies, and the general public. We have received a high level of media and MP interest in our previous work, and will also use these contacts to achieve high coverage of our results.