Table 1

Primary and secondary outcomes, methods and timepoints of assessment

Outcomes	Methods of assessment	Timepoint WP-I	Timepoint WP-II
Patient-reported outcomes
Fatigue (primary outcome)	FACIT-F questionnaire	Daily	Weekly
Autonomic symptoms	COMPASS-31 questionnaire	Baseline, day 7	Baseline, day 7, week 8
SLE disease activity	The SLAQ and PtGA questionnaires	Baseline, day 7	Weekly
Pain	Subjective pain on visual analogue scale	Baseline, day 7	Weekly
Quality of life	SF-12 questionnaire	Baseline, day 7	Baseline, day 7, week 8
Autonomic nervous system function
Resting autonomic function	5 min resting HRV and cardiac vagal tone 5 min resting blood pressure and heart rate Stimulation of sweat glands	Baseline, day 7	Baseline, day 7, week 8
Cardiovascular autonomic reflex function	Four cardiovascular reflex tests and response in changes to heart rate and blood pressure	Baseline, day 7	Baseline, day 7, week 8
Continuous autonomic function	Holter HRV monitoring	Continuously during WP-I	Continuously first week of WP-II
SLE disease activity indices
SLE disease activity	SLEDAI-2K, SRI-50, SLE-DAS, PGA, DAS-28 clinical disease evaluations	Baseline, day 7	Baseline, day 7, week 8
Treatment	Medication history	Retrospective change from inclusion to WP-I until 3 months after WP-II
Organ function
Pain tolerability	Cold pressor test, conditioned pain modulation	Baseline, day 7	Baseline, day 7, week 8
Cardiac function	Echocardiography	Baseline, day 7	Baseline, day 7, week 8
Vascular function	Capillaroscopy and arterial stiffness	Baseline, day 7	Baseline, day 7, week 8
Biochemical function
SLE routine status	Routine assessment of haematological, serological and urinary markers	Baseline, day 7	Baseline, day 7, week 8
SLE inflammatory status	Multiplex plasma cytokines, whole blood expression analyses, flow cytometry, whole blood stimulation assays	Baseline, day 7	Baseline, day 7, week 8
Renal function	eGFR and urine albumin and protein/creatinine ratio, spot-urine	Baseline, day 7	Baseline, day 7, week 8
Metabolic control	Plasma lipid and glucose profiles	Baseline, day 7	Baseline, day 7, week 8

COMPASS, Composite Autonomic Symptoms Score; DAS-28, Disease Activity Score; eGFR, estimated glomerular filtration rate; FACIT-F, Functional Assessment of Chronic Illness Therapy Fatigue; HRV, heart rate variability; PGA, Physician Global Assessment; PtGA, Patient Global Assessment; SF, short form; SLAQ, Systemic Lupus Activity Questionnaire; SLE, systemic lupus erythematosus; SLEDAI-2K, SLE Disease Activity Index 2000; SLE-DAS, SLE-Disease Activity Score; SRI-50, SLEDAI Responder Index-50%; SRI, SLEDAI responder index; WP, work package.