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

Multiple Sclerosis Clinical Trial

— COBRAMS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06280573
• Other study ID #: MS1
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: March 2024
• Source: Comenius University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Combination Product:
• Wim Hoff method
breathing exercises, cold exposure, and meditation

Locations

Country	Name	City	State
Slovakia	Derer's University Hospital	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
Comenius University

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	concentration of pro-inflammatory cytokines	blood concentrations in pg/ml of; • cytokines (interleukins - IL-1ß, IL-6, IL-8, IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33, interferons IFN-a2 and IFN-?, tumor necrosis factor TNF-a, monocyte chemoattractant protein MCP-1)	12 weeks
Primary	concentration of markers of oxidative stress	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
Primary	concentration of NfL	neurofilamen light chains	12 weeks
Primary	concentration of GFAP	glial fibrillary acidic protein	12 weeks
Primary	concentration of ecDNA	cell-free extracellular DNA	12 weeks
Secondary	Expanded Disability Status Scale	physical disability - score from 0.0 to 10.0	12 weeks
Secondary	Timed 25-Foot Walk	walking speed in seconds	12 weeks
Secondary	Nine-Hole Peg Test	finger dexterity in seconds	12 weeks
Secondary	Symbol Digit Modalities Test	cognitive status - score in 90s	12 weeks
Secondary	Fatigue Scale for Motor and Cognitive Functions	to assess multiple sclerosis-related fatigue	12 weeks
Secondary	General Anxiety Disorder-7	level of anxiety	12 weeks
Secondary	Patient Health Questionnaire-9	assesses degree of depression severity	12 weeks