Abstract
ObjectivesThe primary objective of this trial was to assess safety and anti-inflammatory effects of an add-on training program involving breathing exercises, cold exposure, and meditation in patients with axial spondyloarthritisMethodsThis study was an open-label, randomised, one-way crossover clinical proof-of-concept trial. Twenty-four patients with moderately active axial spondyloarthritis(ASDAS >2.1) and hs-CRP ≥5mg/L were included and randomised to an intervention (n = 13) and control group (n = 11) group that additionally received the intervention after the control period. The intervention period lasted for 8 weeks. The primary endpoint was safety, secondary endpoints were change in hs-CRP, serum calprotectin levels and ESR over the 8-week period. Exploratory endpoints included disease activity measured by ASDAS-CRP and BASDAI, quality of life (SF-36, EQ-5D, EQ-5D VAS), and hospital anxiety and depression (HADS).ResultsWe found no significant differences in adverse events between groups, with one serious adverse event occurring 8 weeks after end of the intervention and judged ‘unrelated’. During the 8-week intervention period, there was a significant decline of ESR from (median [interquartile range] to 16 [9–26.5] to 9 [5–23] mm/hr, p = 0.040, whereas no effect was found in the control group (from 14 [8.3–27.3] to 16 [5–37] m/hr, p = 0.406). ASDAS-CRP declined from 3.1 [2.5–3.6] to 2.3 [1.9–3.2] in the intervention group (p = 0.044). A similar trend was observed for serum calprotectin (p = 0.064 in the intervention group versus p = 0.182 in the control group), but not for hs-CRP.ConclusionsThis proof-of-concept study in axial spondyloarthritis met its primary endpoint with no safety signals during the intervention. There was a significant decrease in ESR levels and ASDAS-CRP upon the add-on training program in the intervention group. These findings warrant full-scale randomised controlled trials of this novel therapeutic approach in patients with inflammatory conditions.Trial registrationClinicalTrials.gov; NCT02744014
Highlights
Previous research in healthy individuals exposed to experimental endotoxemia showed that the innate immune response can be voluntarily modulated by a training program involving breathing exercises, exposure to cold and meditation.[1,2] Practicing the techniques learned in the add-on training program induced intermittent respiratory alkalosis and hypoxia, as well as profoundly increased plasma epinephrine levels, indicating activation of the sympathetic nervous system
We found no significant differences in adverse events between groups, with one serious adverse event occurring 8 weeks after end of the intervention and judged ‘unrelated’
Add-on training program in axial spondyloarthritis the 8-week intervention period, there was a significant decline of erythrocyte sedimentation rate (ESR) from
Summary
Previous research in healthy individuals exposed to experimental endotoxemia showed that the innate immune response can be voluntarily modulated by a training program involving breathing exercises, exposure to cold and meditation (further referred to as: ‘add-on training program’).[1,2] Practicing the techniques learned in the add-on training program induced intermittent respiratory alkalosis and hypoxia, as well as profoundly increased plasma epinephrine levels, indicating activation of the sympathetic nervous system. These changes correlated with increased plasma levels of the anti-inflammatory cytokine IL-10 and attenuated levels of pro-inflammatory mediators such as TNF-α, IL-6, and IL-8 during experimental endotoxemia.[2]. More importantly, it is not known whether this training program can safely be applied in patients with a chronic inflammatory disorder
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