To investigate whether an add-on mindset & physical therapy program based on the *Wim Hof Method* can safely and efficaciously be applied in patients with active axial spondyloarthritis.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
- 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)
Background summary
Recent investigations suggest that, through certain concentration/meditation
techniques, it is possible to modulate autonomic activity. The results of a
recent randomized controlled trial investigating the *Wim Hof Method* have
shown a direct biological effect on in-vivo cytokine production and are
strongly encouraging the clinical evaluation of the technique*s efficacy in
immune-mediated inflammatory diseases.
Study objective
To investigate whether an add-on mindset & physical therapy program based on
the *Wim Hof Method* can safely and efficaciously be applied in patients with
active axial spondyloarthritis.
Study design
Prospective open-label randomized controlled trial, safety and efficacy.
Intervention
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 of mindset and concentration, and
gradual cold exposure.
Study burden and risks
The program starts with a 30-days training course introduced by
weekend-sessions (burden 8 hours). Subsequently there will be eight evening
sessions (burden 1-2hours) and patients will be instructed to do a daily
30-minute training session at home. During the four week follow-up study period
there will be one evening session per week led by the instructor (burden
1-2hours per session). Additionally patients are instructed to continue the
30-minute daily practice session at least during the first 60 days or as long
as deemed useful to the patient. Based on empirical data we do not anticipate
treatment related risks related to participation in this study, but it is
possible (though unlikely) that the patient*s condition might worsen.
Furthermore, patients with axSpA are typically young adults with little or no
comorbidity, hence representing a relatively safe study group. The benefits
seem to outweigh the risks as patient*s condition may improve significantly
within 60 days.
Meibergdreef 9
Amsterdam 1100DD
NL
Meibergdreef 9
Amsterdam 1100DD
NL
Listed location countries
Age
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
-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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL55398.018.15 |