Systemic lupus erythematosus Musculoskeletal Diseases
Conditions
Interventions
This study will involve two groups of people with SLE and a third group of healthy female volunteers. For the SLE groups, there will be an intervention group (standard NHS care plus mHealth interventi
Sponsors
University of Birmingham
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Patients: 1. Age >18 years old 2. Female patients with SLE (fulfilling classification criteria [1997 ACR, 2012 SLICC or 2019 EULAR/ACR). Note: approximately 90% of people suffering with SLE are female, hence this inclusion criteria 3. Clinically stable disease activity as assessed by a member of the medical team and deemed eligible for inclusion if they have no A or B scores in the BILAG-2004 index 4. Both participant and physician feel that they are able to exercise safely (PAR-Q screening) 5. Consent: demonstrates an understanding of the study and willingness to participate, as evidenced by voluntary written informed consent Healthy controls: 1. Age: >18 years old 2. Female National online survey: 1. Age: >18 years old 2. Female patients with SLE (fulfilling classification criteria [1997 ACR, 2012 SLICC or 2019 EULAR/ACR). Note: approximately 90% of people suffering with SLE are female, hence this inclusion criteria 3. Clinically stable disease activity as assessed by a member of the medical team and deemed eligible for inclusion if they have no A or B scores in the BILAG-2004 index 4. Both participant and physician feel that they are able to exercise safely (PAR-Q screening) 5. Consent: demonstrates an understanding of the study and willingness to participate, as evidenced by voluntary written informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria for exercise intervention: 1. Increase in the dosage of current lupus-specific medications (e.g., steroids, anti-malarial medications and/or immunosuppressants) within the last 3 months 2. Addition of new lupus-specific medications (e.g., steroids, anti-malarial medications and/or immunosuppressants) within the last 3 months 3. Patients with inactive disease but in whom there is a planned change in medication 4. Uncontrolled blood pressure 5. Pregnancy or planning pregnancy 6. Undertaking over 60 minutes of structured exercise per week 7. Additional health conditions or medication that might put the participant at risk or interfere with a participant’s capacity to exercise will be at the PI’s discretion, e.g., kidney or heart complications 8. Not owning a smart device or having no data plan or access to WiFi 9. Unable to provide full informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Feasibility of the personalised exercise plan will be evaluated by quantifying recruitment, adherence, and completion rates throughout the 12-week intervention (patient exercise group only) 2. Acceptability of the personalised exercise plan will be evaluated using a questionnaire after completion (patient exercise group only) | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Health: 1. The incidence and severity of disease flares will be assessed using The British Isles Lupus Assessment Group (BILAG)-2004 Index at baseline, week 12, and week 18 (patient groups only) 2. Blood pressure and heart rate will be measured using a sphygmomanometer at baseline, week 12, and week 18 (baseline only for the healthy control group) 3. Anthropometric measures (e.g., height, weight, waist circumference, and hip circumference) will be determined at baseline, week 12, and week 18 (baseline only for the healthy control group) 4. Clinical haematology (full blood count), biochemistry (e.g., lipid Panel, complement proteins, c-reactive protein) and autoimmune serology profiles (e.g., quantitative DNA antibodies) will be obtained at baseline, week 12, and week 18 (baseline only for the healthy control group) Immune Cell Profiling: 1. The number of autoreactive immune cells (T and B cells) will be quantified using flow cytometry at baseline, week 12, and week 18 (baseline only for the healthy control group) 2. The metabolic profile of immune cells will be quantified using extracellular flux analysis at baseline, week 12, and week 18 (baseline only for the healthy control group) Lifestyle and Well-Being: 1. Objective physical activity will be evaluated for 7 days at baseline (week prior to intervention), week 11-12 (last week of intervention), and week 18 by using wrist-worn accelerometery (baseline only for the healthy control group) 2. Self-reported physical activity will be measured using the General practice physical activity questionnaire (GPPAQ) at baseline, week 12, and week 18 (baseline only for the healthy control group) 3. Health-related quality of life will be determined by using the lupus-specific quality of life (LupusQoL) questionnaire at baseline, week 12, and week 18 (baseline only for the healthy control group) 4. Fatigue will be determined by using the Multidimensional Fatigue Index (MFI) questionnaire at baseline, week 12, and week | — |
Countries
United Kingdom
Contacts
Public ContactAlex;Megan Wadley;Quickfall
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Outcome results
None listed