COld Exposure With Controlled BReathing And Meditation in Patients With Multiple Sclerosis (COBRAMS) (COBRAMS)

March 17, 2024 updated by: Comenius University

The goal of this interventional study is to test the effect of the anti-inflammatory and neuroprotective effects of this supplementary training program that includes breathing exercises, cold exposure, and meditation in patients diagnosed with multiple sclerosis.

Researchers will compare the effect to control groups of MS patients without intervention.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovakia
      • Bratislava, Slovakia, 83305
        • Derer's University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • RRMS diagnosed according to the official 2020 McDonald's criteria,
  • age 18-55 years,
  • MS duration up to 10 years,
  • EDSS 1.0-5.5,
  • willingness to participate

Exclusion Criteria:

  • relapse or corticosteroid treatment within 3 months prior to study enrollment
  • severe/unstable comorbidity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
Experimental: intervention group
Combination product: Wim Hoff method
breathing exercises, cold exposure, and meditation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
concentration of NfL
Time Frame: 12 weeks
neurofilamen light chains
12 weeks
concentration of GFAP
Time Frame: 12 weeks
glial fibrillary acidic protein
12 weeks
concentration of ecDNA
Time Frame: 12 weeks
cell-free extracellular DNA
12 weeks
concentration of pro-inflammatory cytokines
Time Frame: 12 weeks

blood concentrations in pg/ml of

• cytokines (interleukins - IL-1β, IL-6, IL-8, IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33, interferons IFN-α2 and IFN-γ, tumor necrosis factor TNF-α, monocyte chemoattractant protein MCP-1)
12 weeks
concentration of markers of oxidative stress
Time Frame: 12 weeks
blood concentration in mmol/l of markers of oxidative stress (OS) - advanced glycation end products (AGEs), fructosamine, advanced oxidation protein products (AOPP), thiobarbituric acid reactive substances (TBARS), total antioxidant capacity (TAC), ferric reducing ability of plasma (FRAP),
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expanded Disability Status Scale
Time Frame: 12 weeks
physical disability - score from 0.0 to 10.0
12 weeks
Timed 25-Foot Walk
Time Frame: 12 weeks
walking speed in seconds
12 weeks
Nine-Hole Peg Test
Time Frame: 12 weeks
finger dexterity in seconds
12 weeks
Symbol Digit Modalities Test
Time Frame: 12 weeks
cognitive status - score in 90s
12 weeks
Fatigue Scale for Motor and Cognitive Functions
Time Frame: 12 weeks
to assess multiple sclerosis-related fatigue
12 weeks
General Anxiety Disorder-7
Time Frame: 12 weeks
level of anxiety
12 weeks
Patient Health Questionnaire-9
Time Frame: 12 weeks
assesses degree of depression severity
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Comenius University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 23, 2024

First Submitted That Met QC Criteria

February 23, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 17, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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