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
Buijze GA, De Jong HMY, Kox M, van de Sande MG, Van Schaardenburg D, Van Vugt RM, Popa CD, Pickkers P, Baeten DLP
PloS one · 22 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
Según la declaración de financiación del texto completo.
Publicación
- Publicado
- 2019-12-02 · PLoS One · vol. 14 · número 12 · pág. e0225749
- Editorial
- Public Library of Science
- Citado
- 35 citas · más que el 89% de estudios similares · 2.5× el promedio de su campo
- Referencias
- 15 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY
- Áreas de investigación
- Spondyloarthritis Studies and Treatments · Inflammatory Bowel Disease · Musculoskeletal pain and rehabilitation
- Palabras clave
- axial spondyloarthritis, breathing exercises, cold exposure, meditation, inflammation, disease activity, C-reactive protein, calprotectin, erythrocyte sedimentation rate, quality of life, anxiety and depression, non-pharmacological treatment, safety and tolerability, exercise therapy, ankylosing spondylitis, psoriatic arthritis, reactive arthritis
- MeSH
- humans, spondylarthritis, inflammation, breathing exercises, meditation, endpoint determination, adult, female, male, cold temperature, biomarkers, proof of concept study
9 autores
- Geert Alexander Buijze🇳🇱 · autor de correspondenciaAmsterdam University Medical Centers; University of Amsterdam
- Henriëtte M. de Jong🇳🇱Amsterdam University Medical Centers; University of Amsterdam
- Matthijs Kox🇳🇱Radboud University Nijmegen; Radboud University Medical Center
- Marleen G H van de Sande🇳🇱Amsterdam University Medical Centers; University of Amsterdam
- Dirkjan van Schaardenburg🇳🇱Reade; Amsterdam University Medical Centers; University of Amsterdam
- Richard M. van Vugt🇳🇱Amsterdam University Medical Centers; Vrije Universiteit Amsterdam
- Călin D. Popa🇳🇱Radboud University Nijmegen; Radboud University Medical Center; Sint Maartenskliniek
- Peter Pickkers🇳🇱Radboud University Nijmegen; Radboud University Medical Center
- Dominique Baeten🇳🇱Amsterdam University Medical Centers; University of Amsterdam
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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