TY - JOUR
T1 - 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
AU - Buijze, G. A.
AU - de Jong, H. M.Y.
AU - Kox, M.
AU - van de Sande, M. G.
AU - van Schaardenburg, D.
AU - van Vugt, R. M.
AU - Popa, C. D.
AU - Pickkers, P.
AU - Baeten, D. L.P.
PY - 2019/1/1
Y1 - 2019/1/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85075791601&partnerID=8YFLogxK
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85075791601&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/31790484
U2 - https://doi.org/10.1371/journal.pone.0225749
DO - https://doi.org/10.1371/journal.pone.0225749
M3 - Article
C2 - 31790484
SN - 1932-6203
VL - 14
JO - PLOS ONE
JF - PLOS ONE
IS - 12
M1 - e0225749
ER -