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

Not Applicable

Active, not recruiting

• Conditions: Multiple Sclerosis
• Interventions: Combination Product: Wim Hoff method

• Registration Number: NCT06280573
• Lead Sponsor: Comenius University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2024-01-23
• Study First Submitted QC: 2024-02-23
• Study First Posted: 2024-02-28
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-17
• Last Update Posted: 2024-03-19
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	Wim Hoff method	-

Primary Outcome Measures

Name	Time	Method
concentration of markers of oxidative stress	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),
concentration of pro-inflammatory cytokines	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)
concentration of NfL	12 weeks	neurofilamen light chains
concentration of GFAP	12 weeks	glial fibrillary acidic protein
concentration of ecDNA	12 weeks	cell-free extracellular DNA

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Derer's University Hospital; 🇸🇰 Bratislava, Slovakia