Axial Spondyloarthritis Bechterew
Conditions
Interventions
A 60-day training program of add-on mindset and physical therapy for axial
spondyloarthritis, using the methodology as designed and instructed by Wim Hof.
It involves breathing techniques, training
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Clinical diagnosis of axSpA as assessed by the treating rheumatologist fulfilling the ASAS classification for axial SpA [Rudwaleit 2009] -Between 18 and 55 years of age at screening -Active disease as defined by an Ankylosing Spondylitis Disease Activity Score (ASDAS) of >2.1 and a CRP value of *5 at the screening visit. -Ability and willingness to participate to the study and give written informed consent.
Exclusion criteria
Exclusion criteria: -Patients who cannot give written consent or, in the opinion of the investigator, cannot comply to the requirements of the study protocol. Significant comorbidity, including a cardiac, renal, hepatic, neurological, metabolic or any other severe disease, which in the opinion of the investigator may interfere with the study or lead to deleterious effects for the patient. -Recent history of (or persistent) infection requiring hospitalization or antibiotic treatment within 4 weeks of baseline. -If female, patient should not be pregnant. A urine pregnancy-test will be performed at screening and has to be negative. -Initiation of treatment with corticosteroids or DMARDs (synthetic and biologic) within 8 weeks before screening. -Initiation of treatment with NSAID within 2 weeks before screening. -Variation of the treatment doses within 6 weeks of screening. -Intra-articular injection with corticosteroids within 4 weeks prior to screening. -Daily doses of systemic corticosteroids exceeding the equivalent of 10 mg prednisolone per day. -Use of other drugs and treatments that may affect the evaluation of systemic inflammation as judged by the investigator. -Cardiovascular risk factors such as a personal history of cardiovascular disease, familial history of major adverse cardiovascular events (MACE) at age younger than 55 yrs, hypercholesterolemia and stroke.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation of the program is the primary aim of the study, and therefore, the primary outcome measure is chosen to detect changes at the level of severity of the axial spondyloarthritis (axSpA) using clinical parameters. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Difference in CRP between baseline and week 8 - Difference in circulating cytokines between baseline and week 8 - Change in Ankylosing Spondylitis Disease Activity Score (ASDAS) - Change in other serum inflammation biomarkers (ESR, calprotectin) - Change in quality of life as measured by the SF-36, the EQ-5D - Change in depressive symptoms as measured by the Beck Depression Inventory (BDI-II) - Predictive role of generalized and specific outcome expectancies (EPQ-N, LOT-R, VAS scales) | — |
Countries
Netherlands
Outcome results
None listed