Trial reportPloS one2019
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.
Trial report in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02744014 (Evidence-Based Mindset & Physical Therapy for Add-on Treatment of Active Axial Spondyloarthritis), which is not on this map. Cited by 18 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Evidence-Based Mindset & Physical Therapy for Add-on Treatment of Active Axial Spondyloarthritis: Safety and Efficacy
Who cites it
18 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.
- Pooled it
- The effect of breathing exercises and mindset with or without cold exposure on mental and physical health in persons with a spinal cord injury-Results of a randomized controlled trial.Clinical rehabilitation · 2026Trial
- A semi-randomised control trial assessing psychophysiological effects of breathwork and cold immersion.Scientific reports · 2025Trial
- Targeting low-grade inflammation in multiple sclerosis through the Wim Hof method or lifestyle intervention: a pilot comparative study.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026Article
- The untapped potential of cold water therapy as part of a lifestyle intervention for promoting healthy aging.GeroScience · 2025Review
- Combined cold-water immersion and breathwork may be associated with improved mental health and reduction in the duration of upper respiratory tract infection - a case-control study.International journal of circumpolar health · 2024Article
- A randomized controlled clinical trial of a Wim Hof Method intervention in women with high depressive symptoms.Comprehensive psychoneuroendocrinology · 2024Article
- Article
- The Effect of Mindset and Breathing Exercises on Physical and Mental Health in Persons with Spinal Cord Injury-A Pilot Feasibility Study.International journal of environmental research and public health · 2023Article
- Biomodulating healing after arthroscopic rotator cuff repair: the protocol of a randomised proof of concept trial (BIOHACK).BMJ open · 2023Article
- Conscious connected breathing with breath retention intervention in adults with chronic low back pain: protocol for a randomized controlled pilot study.Pilot and feasibility studies · 2023Article
- The positive effects of combined breathing techniques and cold exposure on perceived stress: a randomised trial.Current psychology (New Brunswick, N.J.) · 2022Article
- Utilization of Mind-Body Intervention for Integrative Health Care of COVID-19 Patients and Survivors.International journal of environmental research and public health · 2022Review
- A novel Wim Hof psychophysiological training program to reduce stress responses during an Antarctic expedition.The Journal of international medical research · 2022Observational
- Yoga, Meditation, Breathing Exercises, and Inflammatory Biomarkers with Possible Implications in COVID-19: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Evidence-based complementary and alternative medicine : eCAM · 2022Review
- Treat-to-target in axial spondyloarthritis - what about physical function and activity?Nature reviews. Rheumatology · 2021Review
- Impact of Exercise Intensity on Calprotectin Levels in Healthy Volunteers and Patients with Inflammatory Rheumatic Diseases.Life (Basel, Switzerland) · 2021Review
- Can Yogic Breathing Techniques LikeFrontiers in psychology · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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 spondyloarthritis.
methodsThis 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.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.