Dataset Information

A randomized clinical trial to stimulate the cholinergic anti-inflammatory pathway in patients with moderate COVID-19-pneumonia using a slow-paced breathing technique.

ABSTRACT:

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.

SUBMITTER: Balint EM

PROVIDER: S-EPMC9574246 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Publications

A randomized clinical trial to stimulate the cholinergic anti-inflammatory pathway in patients with moderate COVID-19-pneumonia using a slow-paced breathing technique.

Balint Elisabeth Maria EM Grüner Beate B Haase Sophia S Kaw-Geppert Mandakini M Thayer Julian F JF Gündel Harald H Jarczok Marc N MN

Frontiers in immunology 20221003

<h4>Purpose</h4>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.<h4>Method</h4>Single-center randomized controlled clinical trial with enrolment of 46 patients hospitalized with confirmed ...[more]

PMID: 36263035

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Project description:This research aims to investigate whether slow-paced breathing (SPB) improves adaptation to psychological stress, and specifically inhibition, when it is performed before or after physical exertion (PE). According to the resonance model, SPB is expected to increase cardiac vagal activity (CVA). Further, according to the neurovisceral integration model, CVA is positively linked to executive cognitive performance, and would thus play a role in the adaptation to psychological stress. We hypothesized that SPB, in comparison to a control condition, will induce a better adaptation to psychological stress, measured via better inhibitory performance. Two within-subject experiments were conducted with athletes: in the first experiment (N = 60) SPB (or control - neutral TV documentary) was realized before PE ("relax before PE"), and in the second experiment (N = 60) SPB (or the watching TV control) was realized after PE ("relax after PE"). PE consisted of 5 min Burpees, a physical exercise involving the whole body. In both experiments the adaptation to psychological stress was investigated with a Stroop task, a measure of inhibition, which followed PE. Perceived stress increased during PE (partial η2 = 0.63) and during the Stroop task (partial η2 = 0.08), and decreased during relaxation (partial η2 = 0.15), however, no effect of condition was found. At the physiological level PE significantly increased HR, RF, and decreased CVA [operationalized in this research via the root mean square of successive differences (RMSSD)] in both experiments. Further, the number of errors in the incongruent category (Stroop interference accuracy) was found to be lower in the SPB condition in comparison to the control condition, however, these results were not mediated by RMSSD. Additionally, the Stroop interference [reaction times (RTs)] was found to be lower overall in "relax before PE," however, no effect was found regarding SPB and Stroop interference (RTs). Overall, our results suggest that SPB realized before or after PE has a positive effect regarding adaptation to psychological stress and specifically inhibition, however, the underlying mechanisms require further investigation.

Dataset Information

A randomized clinical trial to stimulate the cholinergic anti-inflammatory pathway in patients with moderate COVID-19-pneumonia using a slow-paced breathing technique.

Purpose

Method

Results

Conclusion

Clinical trial registration

Publications

A randomized clinical trial to stimulate the cholinergic anti-inflammatory pathway in patients with moderate COVID-19-pneumonia using a slow-paced breathing technique.

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