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Add-on Therapy for Axial Spondyloarthritis

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ClinicalTrials.gov Identifier: NCT02744014
Recruitment Status : Completed
First Posted : April 19, 2016
Last Update Posted : June 12, 2018
Sponsor:
Collaborators:
Bernhoven Hospital
Radboud University
Information provided by (Responsible Party):
D.L.P. Baeten, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Tracking Information
First Submitted Date  ICMJE March 2, 2016
First Posted Date  ICMJE April 19, 2016
Last Update Posted Date June 12, 2018
Actual Study Start Date  ICMJE April 21, 2016
Actual Primary Completion Date March 22, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2016)
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 60 days ]
    Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
  • Change in CRP value [ Time Frame: 60 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02744014 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2016)
  • Change in circulating cytokines [ Time Frame: 30, 60, 180 days ]
  • Change in other serum inflammation biomarkers (ESR, calprotectin) [ Time Frame: 30, 60, 180 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 15, 2016)
  • Change in disease activity as measured by the Ankylosing Spondylitis Disease Activity Score (ASDAS) [ Time Frame: 30, 60, 180 days ]
  • Change in quality of life as measured by the SF-36 [ Time Frame: 30, 60, 180 days ]
  • Change in quality of life as measured by the EQ-5D [ Time Frame: 30, 60, 180 days ]
  • Change in depressive symptoms as measured by the Hospital Anxiety Depression Score (HADS). [ Time Frame: 30, 60, 180 days ]
  • Generalized expectations as measured by the Eysenck Personality Questionnaire - Neuroticism scale (EPQ-N) [ Time Frame: Baseline ]
  • Generalized expectations as measured by the Eysenck Personality Questionnaire - Life Orientation Test-Revised (LOT-R). [ Time Frame: Baseline ]
  • Specific expectations regarding the effects of the training, measured by VAS scales that are framed to the specific intervention. [ Time Frame: Baseline ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Add-on Therapy for Axial Spondyloarthritis
Official Title  ICMJE Evidence-Based Mindset & Physical Therapy for Add-on Treatment of Active Axial Spondyloarthritis: Safety and Efficacy
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).

Detailed Description

Axial spondyloarthritis (axSpA) is a common systemic autoinflammatory disease affecting approximately 7 in 1.000 individuals. Recent investigations suggest that, through certain concentration/meditation techniques, it is possible to modulate autonomic activity. The endotoxemia experiment in an individual (named Wim Hof) who used a self-created concentration/meditation technique is strongly supportive of these findings. The use of his technique - including breathing techniques, training of mindset and concentration, and gradual cold exposure - seemed to evoke a controlled stress response. This response was characterized by sympathetic nervous system activation and subsequent catecholamine/cortisol release, which seemed to attenuate the innate immune response. The remarkable results in the studied individual led to a randomised controlled trial of this technique at the Radboud UMC. Twenty-four healthy individuals were randomised to receive an instruction course of the technique or no instructions at all and subsequently underwent an endotoxemia experiment. The experiment involved the intravenous administration of very low doses of lipopolysaccharide and measuring the in-vivo cytokine response and clinical symptoms. The results of this study have shown a direct biological effect on in-vivo cytokine production and are strongly encouraging the evaluation of the technique's efficacy in clinical practice.

The techniques of the Wim Hof Method have been modulated to a scientifically reproducible mindset & physical training program for add-on therapy of axSpA. Specifically, it has been adjusted for potential functional limitations of axSpA.

Primary Objective: To investigate whether the add-on mindset & physical therapy program can safely be applied in patients with active axSpA using clinical safety parameters.

Secondary Objective: To assess whether the add-on mindset & physical therapy program can modulate objective signs of inflammation in patients with active axSpA using serum biomarkers (e.g. CRP).

Exploratory objective: To assess whether the add-on mindset & physical therapy program has an influence on the Ankylosing Spondylitis Disease Activity Score, quality of life, and depressive symptoms (HADS), and to explore the predictive role of generalized and specific outcome expectancies in patients with active axSpA

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Axial Spondyloarthritis
Intervention  ICMJE Behavioral: Add-on Therapy for Axial Spondyloarthritis
Other Name: Wim Hof Method
Study Arms  ICMJE
  • Experimental: Early intervention group
    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.
    Intervention: Behavioral: Add-on Therapy for Axial Spondyloarthritis
  • Late intervention group
    This group will receive the same training with a delay of 60-90 days, serving initially as control.
    Intervention: Behavioral: Add-on Therapy for Axial Spondyloarthritis
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 15, 2016)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 19, 2017
Actual Primary Completion Date March 22, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

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 45 yrs, hypercholesterolemia and stroke.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02744014
Other Study ID Numbers  ICMJE Academic_Medical_Center
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party D.L.P. Baeten, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Sponsor  ICMJE Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators  ICMJE
  • Bernhoven Hospital
  • Radboud University
Investigators  ICMJE
Principal Investigator: Dominique Baeten, MD PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
PRS Account Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP