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


Autoři: G. A. Buijze aff001;  H. M. Y. De Jong aff002;  M. Kox aff003;  M. G. van de Sande aff002;  D. Van Schaardenburg aff002;  R. M. Van Vugt aff005;  C. D. Popa aff006;  P. Pickkers aff003;  D. L. P. Baeten aff002
Působiště autorů: Department of Orthopaedic Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands aff001;  Department of Rheumatology and Clinical Immunology, Amsterdam UMC, University of Amsterdam, Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands aff002;  Department of Intensive Care Medicine, Nijmegen Institute for Infection, Inflammation and Immunity, RadboudUMC Nijmegen, Nijmegen, The Netherlands aff003;  Reade, Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands aff004;  Department of Rheumatology and Clinical Immunology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands aff005;  Department of Rheumatology, Sint Maartenskliniek, Nijmegen, The Netherlands aff006;  Department of Rheumatology, RadboudUMC Nijmegen, Nijmegen, The Netherlands aff007
Vyšlo v časopise: PLoS ONE 14(12)
Kategorie: Research Article
doi: 10.1371/journal.pone.0225749

Souhrn

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

Klíčová slova:

Adverse events – Breathing – Exercise – Immune response – Inflammatory bowel disease – Inflammatory diseases – NSAIDs – Quality of life


Zdroje

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2019 Číslo 12