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Can Pilates and Tai Chi group online classes improve fatigue and mental health symptoms in patients with rheumatological diseases?

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13944706
Enrollment
420
Registered
2025-08-19
Start date
2026-01-14
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatological diseases Musculoskeletal Diseases

Interventions

Participants are randomly divided into three groups. One group will receive usual care (i.e. the control group), one will be offered Pilates classes, and the other group will be offered Tai Chi classe

Sponsors

University of East Anglia
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 years and over 2. Resident in the UK 3. Report a diagnosis of a systemic autoimmune rheumatic disease (SARD). These include, but are not limited to, inflammatory arthritis, systemic lupus erythematosus, systemic sclerosis, Sjögren’s, myositis, vasculitis, and undifferentiated (UCTD) or mixed (MCTD) connective tissue disease 4. Report a score of 3 or more on question 1 of the Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scale (BRAF-NRS) for fatigue severity 5. Able to attend a minimum of two exercise classes per week, from the choice of timeslots offered in the expression of interest form 6. Understand spoken English language 7. Able to read/write English

Exclusion criteria

Exclusion criteria: 1. Are unable to provide informed consent 2. Currently attend regular exercise classes, either in person or online, once a week or more regularly. Added 30/09/2025: An exercise class is defined as an instructor-led session delivered either online or in person. Online classes include those delivered live in real time (e.g. over Zoom) and videos accessed on demand and/or catch up (e.g. YouTube). 3. Have medical (physical and/or mental health) instability or comorbidities preventing safe participation in physical activity 4. Are participating in another fatigue-related intervention study

Design outcomes

Primary

MeasureTime frame
Fatigue measured by Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) at baseline and 6 months post-randomisation

Secondary

MeasureTime frame
1. Fatigue measured by FACIT-Fatigue at baseline, 10 weeks and 18 weeks post-randomisation 2. Quality of life measured by the EQ-5D-5L at baseline, 10 weeks and 6 months 3. Depression measured by the Patient Health Questionnaire –8 (PHQ-8) at baseline, 10 weeks and 6 months 4. Anxiety measured by the Generalised Anxiety Disorder Questionnaire (GAD-7) at baseline, 10 weeks and 6 months 5. Cognitive dysfunction measured by the Cognitive Failures Questionnaire (CFQ) 2.0 at baseline, 10 weeks and 6 months 6. Resilience measured by the Connor-Davidson resilience scale (CD-RISC 10) at baseline, 10 weeks and 6 months 7. Physical activity measured by the International Physical Activity Questionnaire (IPAQ-SF) at baseline, 10 weeks and 6 months 8. Coping, control, participation in life, and satisfaction with life, measured using the ADAPT instrument, our patient-designed disease adapting tool, at baseline, 10 weeks, 18 weeks and 6 months 9. Proportion of participants achieving oral steroid reduction, measured using a non-validated four-item questionnaire at baseline and 6 months post-intervention 10. Proportion of participants achieving opioid reduction, measured using a non-validated single-item question at 6 months post-intervention In addition, the following will be measured: 1. Views and experiences of the exercise classes, collected via in-depth qualitative interviews at 6 months 2. Health and social care use, and costs borne by patients, measured using a retrospective resource use questionnaire at baseline and 6 months

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 25, 2026