An add-on training program involving breathing exercises, cold exposure, and meditation attenuates inflammation and disease activity in axial spondyloarthritis - A proof of concept trial.
Author: Buijze GA1, De Jong HMY2, Kox M3, van de Sande MG2, Van Schaardenburg D2,4, Van Vugt RM5, Popa CD6,7, Pickkers P3, Baeten DLP2
Affiliation:
1Department of Orthopaedic Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
2Department of Rheumatology and Clinical Immunology, Amsterdam UMC, University of Amsterdam, Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands.
3Department of Intensive Care Medicine, Nijmegen Institute for Infection, Inflammation and Immunity, RadboudUMC Nijmegen, Nijmegen, The Netherlands.
4Reade, Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands.
5Department of Rheumatology and Clinical Immunology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
6Department of Rheumatology, Sint Maartenskliniek, Nijmegen, The Netherlands.
7Department of Rheumatology, RadboudUMC Nijmegen, Nijmegen, The Netherlands.
Conference/Journal: PLoS One.
Date published: 2019 Dec 2
Other:
Volume ID: 14 , Issue ID: 12 , Pages: e0225749 , Special Notes: doi: 10.1371/journal.pone.0225749. eCollection 2019. , Word Count: 291
OBJECTIVES: The 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 spondyloarthritis.
METHODS: This 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).
RESULTS: 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'. 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.
CONCLUSIONS: This 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 REGISTRATION: ClinicalTrials.gov; NCT02744014.
PMID: 31790484 DOI: 10.1371/journal.pone.0225749
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