Add-on Therapy for Axial Spondyloarthritis

NCT02744014 | Completed

• 1 other identifier: Academic_Medical_Center
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

Rationale: 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. 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. Study population: Twenty-four patients with active axial spondyloarthritis between 18 and 45 years of age. Intervention: A 30-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. Main study parameters/endpoints: Safety evaluation of the program is the primary aim of the study. Secondary endpoint is the modulation of serum CRP levels. Exploratory objectives include modulation of clinical disease activity (ASDAS), quality of life (SF-36, EQ-5D), depressive symptoms (HADS), and predictive role of generalized and specific outcome expectancies (EPQ-N, LOT-R, VAS scales).

Conditions

Axial Spondyloarthritis

Outcome Measures

Primary Outcomes (2)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

  60 days

• Change in CRP value

  60 days

Secondary Outcomes (2)

• Change in circulating cytokines

  30, 60, 180 days

• Change in other serum inflammation biomarkers (ESR, calprotectin)

  30, 60, 180 days

Other Outcomes (7)

• Change in disease activity as measured by the Ankylosing Spondylitis Disease Activity Score (ASDAS)

  30, 60, 180 days

• Change in quality of life as measured by the SF-36

  30, 60, 180 days

• Change in quality of life as measured by the EQ-5D

  30, 60, 180 days

Study Arms (2)

Early intervention group

EXPERIMENTAL

The program starts with a 30-days training course led by course instructor Wim Hof and supervised by the research team. The mindset \& physical therapy based on the Wim Hof Method includes breathing techniques, training of mindset and concentration, and gradual cold exposure.

Behavioral: Add-on Therapy for Axial Spondyloarthritis

Late intervention group

OTHER

This group will receive the same training with a delay of 60-90 days, serving initially as control.

Behavioral: Add-on Therapy for Axial Spondyloarthritis

Interventions

Add-on Therapy for Axial Spondyloarthritis BEHAVIORAL

Also known as: Wim Hof Method

Early intervention group; Late intervention group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of axSpA as assessed by the treating rheumatologist fulfilling the ASAS classification for axial SpA \[Rudwaleit 2009\]
• Between 18 and 45 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.

You may not qualify if:

• 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 45 yrs, hypercholesterolemia and stroke.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Bernhoven Hospital: collaborator
• Radboud University Medical Center: collaborator

Study Sites (2)

Academic Medical Center

Amsterdam, Netherlands

Location

Ziekenhuis Bernhoven

Uden, Netherlands

Location

Related Publications (3)

• Kox M, Stoffels M, Smeekens SP, van Alfen N, Gomes M, Eijsvogels TM, Hopman MT, van der Hoeven JG, Netea MG, Pickkers P. The influence of concentration/meditation on autonomic nervous system activity and the innate immune response: a case study. Psychosom Med. 2012 Jun;74(5):489-94. doi: 10.1097/PSY.0b013e3182583c6d.

  PMID: 22685240 BACKGROUND

• Kox M, van Eijk LT, Zwaag J, van den Wildenberg J, Sweep FC, van der Hoeven JG, Pickkers P. Voluntary activation of the sympathetic nervous system and attenuation of the innate immune response in humans. Proc Natl Acad Sci U S A. 2014 May 20;111(20):7379-84. doi: 10.1073/pnas.1322174111. Epub 2014 May 5.

  PMID: 24799686 RESULT

• Buijze GA, De Jong HMY, Kox M, van de Sande MG, Van Schaardenburg D, Van Vugt RM, Popa CD, Pickkers P, Baeten DLP. 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. PLoS One. 2019 Dec 2;14(12):e0225749. doi: 10.1371/journal.pone.0225749. eCollection 2019.

  PMID: 31790484 DERIVED

MeSH Terms

Conditions

Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Dominique Baeten, MD PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: April 19, 2016
• Study Start: April 21, 2016
• Primary Completion: March 22, 2017
• Study Completion: December 19, 2017
• Last Updated: June 12, 2018

Record last verified: 2018-06

Locations

NL (2)