PURPOSE: A characteristic problem occurring in COVID-19 is excessive elevations of pro-inflammatory cytokines (e.g. IL-6 and CRP) which are associated with worse clinical outcomes. Stimulation of the vagally-mediated cholinergic anti-inflammatory reflex by slow paced breathing with prolonged exhalation may present a clinically relevant way to reduce circulating IL-6. METHOD: Single-center randomized controlled clinical trial with enrolment of 46 patients hospitalized with confirmed severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) infection and moderate COVID-19 pneumonia (primary diagnosis). Differences between intervention (4sec inhalation, 6sec exhalation for 20 minutes 3x daily) and control group in IL-6 calculated using multilevel mixed-effect linear regression models with random slope including the covariates relevant comorbidities, COVID-19 medication, and age. Both groups received standard care. RESULTS: Mean age was 57 years ± 13 years, N= 28 (60%) male, N=30 (65%) with relevant comorbidities. The model including group-by-time interaction revealed a significantly lower trajectory of IL-6 in the intervention group (effect size Cohens f2 = 0.11, LR-test p=.040) in the intention-to-treat sample, confirmed by per-protocol analysis (f2 = 0.15, LR-test p=.022). Exploratory analysis using the median split of practice time to predict IL-6 of the next morning indicated a dose-response relationship with beneficial effects of practice time above 45 minutes per day. Oxygen saturation remained unchanged during slow-paced breathing (95.1% ± 2.1% to 95.4% ± 1.6%). CONCLUSION: Patients practicing slow-paced breathing had significantly lower IL-6 values than controls with a small to medium effect size and without relevant side effects. Further trials should evaluate clinical outcomes and an earlier start of the intervention. Slow-paced breathing could be an easy to implement, low-cost, safe and feasible adjuvant therapeutic approach to reduce circulating IL-6 in moderate COVID-19 pneumonia. CLINICAL TRIAL REGISTRATION: https://www.drks.de, identifier DRKS00023971, Universal Trial Number (UTN) U1111-1263-8658.

New tools for non-specific primary prevention strategies covering somatic and mental health in occupational medicine are urgently needed. Heart rate variability (HRV) reflects the capacity of the body to adapt to environmental challenges and of the mind to regulate emotions. Hence, a 24 h-measurement of HRV offers a unique possibility to quantify the interaction between situation-specific emotional regulation within a specific psychosocial environment and physiological state, thereby increasing self-perception and inducing motivation to change behavior. The focus of the present study represents such a 24 h-measurement of HRV and its presentation as a comprehensive graph including protocol situations of the client. A special training program for occupational health physicians and questionnaires for clients were developed and administered. The article reports the first data of the study healthy leadership and work - body signals for managers and employees, an investigator-initiated, interventional, single-arm, open (non-blinded), multicenter, national trial with 168 participants. They reported a significantly improved perception of their bodily needs after the consultation (from Median = 7, interquartile range 5-8 to Median = 8, interquartile range 7-9; scale range from 1 to 10; p < 0.001, Wilcoxon rank test; effect size 0.49). The 16 occupational health physicians stated that the measurement of HRV was very well suited to enter into dialog with the managers and was feasible to show interactions between situations, thoughts, feelings, and bodily reactions. Taken together, we show that a 24 h-HRV-measurement can be a feasible and effective approach for holistic, psychosomatic primary prevention in occupational medicine. We discuss possible mechanisms for improving the individual health via the consultation, containing mindset and improved ANS activity.