RA reumatoid arthritis
Conditions
Interventions
a cold exposure course and training in *Strength Ventilation* breathing
technique in various modalities:
1. `Cold Exposure` group. A group of subjects (n=12) that will receive an
extensive cold expo
Sponsors
Intensive Care
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Written informed consent Age >=18 and
Exclusion criteria
Exclusion criteria: Prior experience with any of the elements of the intervention developed by Hof;Prior experience with other breathing, meditation, or cold exposure techniques;Use of any medication;Smoking;History of asthma;Previous spontaneous vagal collapse;History of atrial or ventricular arrhythmia;(Family) history of myocardial infarction or stroke under the age of 65 years;Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrioventricular block or a complex bundle branch block;Hypertension (defined as RR systolic > 160 or RR diastolic > 90);Hypotension (defined as RR systolic < 100 or RR diastolic < 50);Renal impairment (defined as plasma creatinin >120 µmol/l);Liver enzyme abnormalities;Medical history of any disease associated with immune deficiency;CRP > 20 mg/L, WBC > 12x109/L, or clinically significant acute illness, including infections, within;4 weeks before endotoxin administration;Participation in a drug trial or donation of blood 3 months prior to the LPS challenge;Use of recreational drugs within 7 days prior to endotoxemia experiment day;Recent hospital admission or surgery with general anaesthesia (<3 months)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is the difference in circulating TNF-a over time following LPS administration between groups | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences between groups in: - Levels of other circulating cytokines (including, but not limited to IL-6, IL-10 and IL-1RA) - Plasma adrenaline levels - Plasma cortisol levels - Blood gas parameters - Mitochondrial oxygen tension - Metabolome - Body temperature - Illness score - Hemodynamic parameters (heart rate, blood pressure) - Leukocyte counts and differentiation - Pain thresholds - Presence of TLR ligands in plasma - HSP70 levels in plasma. - Production of inflammatory mediators by ex vivo-stimulated leukocytes - Inflammatory transcriptional pathways (by use of qPCR/microarrays/RNA sequencing - Heart rate variability | — |
Countries
Netherlands
Outcome results
None listed